undertaking of proper information provided at ce/unfp

36
Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22 Sr. Company Name Item Code Generic Name Pack Size Mfg By Quoted Brand Strength Country of Origin Valid License to Manufactur e/Import Medical Devices DSL (For Sole agent) Undertaking of valid sole agency agreement Undertaking of not blacklisted/ debarred by any procuring agency. Firm will provide valid ISO 13485. Valid GMP (For local manufact urer) Valid CE/UNFP A/JMHLW /US FDA approval certificati on or prequalifi cation by WHO Undertaking of Proper warehouseproper warehouse and storage facility as per recommendation of the manufacturer and at required temperature and follows good storage and distribution practice. Firm will provide undertaking on legally notarized stamp paper of rupees 100. Procuring Agency may physically verify firm’s claim. Firm must mention address of its storage facility on undertaking. Information provided at Annexure-A, B,C, and E or any other information provided in accordance with terms & conditions of the PQD Minimum Annual financial turnover Valid registration of manufacturing firm with chamber of commerce from country of manufacturer. Building fitness certificate (For manufacture r only) Undertaking following labor laws (For manufacturer only) Undertaking of its supplied batch in Public Sector Institutions has been declared Spurious/Adulte rated Form-29 issued by SECP. (Article of association of companies) /Form C (Registered from registrar of firms)/ sole proprietorship. (For manufacturer only) Undertaking of Non prosecuted by PQCB on the offense of Spurious/Adulte rated Medical Device. Original Receipt Undertaki ng of acceptanc e of T&C of PQD Apply on online portal (PQOD) Valid CE/UNFP A/JMHLW /US FDA approval certificati on or prequalifi cation by WHO Device Enlistment Certificate Undertaking for Required storage temperature as per product's requirement Valid Sole Agency Agreemen t of quoted item foratleast one year (for importers) Public Sector Purchase Orders (Last Three Years) Undertaking for Spurious/Ad ulterated Samples for quoted item Undertaking for substandard samples of quoted item not over 5% since 01-01- 2020 Undertaking for substandard batch recall history since 01-01-2020 Undertaking for any punitive action taken by DRAP since 01-01-2020 Undertaking for any punitive action taken by PQCB since 01-01-2020 GDs certificates for quoted item for atleast last three consective years Status Remarks 1 3N-Lifemed 9 Bicarbonate Solution of appropriate composition for hemodialysis 4 3N- Lifemed Sargodha , Pakistan Lifemed Bicarb Concentrate 4 Liter to 10 Liter Pakistan Yes Yes N/A Yes Yes Yes No Yes Yes No N/A Yes Yes Yes No Yes Yes Yes Yes No No Yes N/A Yes Yes Yes Yes Yes Yes N/A Not- Prequalified 1. The firm did not attach Valid CE/UNFPA/JMHLW/US FDA approval certification or prequalification by WHO for the quoted item. 2. The Annual financial turnover of the firm is less than the required Minimum Annual financial turnover i.e., 330 Million as per clause no. 10 of the firm wise knockdown criteria of the prequalification document. 3. The firm did not attach Form-29 issued by SECP. /Form C / sole proprietorship. 4. The firm did not attach valid DRC/Device Enlistment certificate of the quoted item. 2 AKRAM BROTHERS & CO 10 Black Silk, Size 2/0,60mm straight cutting needle 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO Black Braided Silk Suture WEGO Black Braided Silk Suture Size 2/0, 60mm Straight Cutting Needle China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 3 AKRAM BROTHERS & CO 11 Black Silk, Size 1, 30mm, 1/2Circle round body needle 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO Black Braided Silk Suture WEGO Black Braided Silk Suture Size 1, 30mm 1/2 Circle Round Body Needle China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 4 AKRAM BROTHERS & CO 12 Black Silk, Size1,40mm 3/8 Circle curve cutting (CC) needle 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO Black Braided Silk Suture WEGO Black Braided Silk Suture Size 1, 40mm 3/8 Circle Curved Cutting China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 5 AKRAM BROTHERS & CO 13 Black Silk,2/0,30mm 1/2 circle round body needle 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO Black Braided Silk Suture WEGO Black Braided Silk Suture 2/0, 30mm 1/2 Circle Round Body China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 6 AKRAM BROTHERS & CO 18 Catgut Chromic, Size 1, with 40mm Intestinal RB Needle 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO Chromic Catgut WEGO Chromic Catgut Size 1, 40mm 1/2 Circle Round Body China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 7 AKRAM BROTHERS & CO 19 Catgut Chromic, Size 1,30mm, ½ Circle RB Needle 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO Chromic Catgut WEGO Chromic Catgut Size 1, 30mm 1/2 Circle Round Body China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 8 AKRAM BROTHERS & CO 20 Catgut Chromic, Size 1,40mm, curved Needle 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO Chromic Catgut WEGO Chromic Catgut Size 1, 40mm Curved Cutting Needle China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 9 AKRAM BROTHERS & CO 21 Catgut Chromic, Size2/0 ,30mm, 1/2 Circle Round Body needle 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO Chromic Catgut WEGO Chromic Catgut Size 2/0, 30mm 1/2 Circle Round Body China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 10 AKRAM BROTHERS & CO 49 Poly propylene Size 1, 40mm 1/2 circle RB Needle 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO Prolene Polypropylene WEGO Prolene Polypropylene 1, 40mm 1/2 Circle Round Body China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 11 AKRAM BROTHERS & CO 50 Poly propylene, Size 2/0, 30mm 1/2 circle RB Needle 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO Prolene Polypropylene WEGO Prolene Polypropylene Size 2/0, 30mm 1/2 Circle Round Body China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 12 AKRAM BROTHERS & CO 51 Poly propylene, Size 2/0,60mm Straight Cutting needle (SCN) 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO Prolene Polypropylene WEGO Prolene Polypropylene 2/0, 60,, Staright Cutting China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 13 AKRAM BROTHERS & CO 52 Polyglactin/ Polyglycolic acid, Size 1,40mm.1/2 Circle Round Body needle 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO PGA Polyglycolic Acid/ WEGO PGLA Poly Lactic co Glycolic Acid WEGO PGA Polyglycolic Acid/WEGO PGLA Poly Lactic co Glycolic Acid Size 1, 40mm 1/2 Circle Round Body China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 14 AKRAM BROTHERS & CO 53 Polyglactin/ Polyglycolic acid, size 2/0,30mm, 1/2 Circle Round Body needle 12 WEGO Sutures Foosin Medical Supplies Inc. Ltd. WEGO PGA Polyglycolic Acid/ WEGO PGLA Poly Lactic co Glycolic Acid WEGO PGA Polyglycolic Acid/ WEGO PGLA Poly Lactic co Glycolic Acid 2/0, 30mm 1/2 Circle Round Body China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach valid Device Enlistment certificate of the quoted item. 15 AL-HAMD ENTERPRISES 34 Examination Gloves Latex (S.M.L) 100 Tan Sin Lian Industrie s Sdn Bhd Optishield S,M.L Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Not- Prequalified 1. The firm did not attach FBR sales/income tax returns of last three financial/calendar years. Page 1 of 29

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Page 1: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

1 3N-Lifemed 9Bicarbonate Solution of

appropriate composition

for hemodialysis

4

3N-

Lifemed

Sargodha

, Pakistan

Lifemed Bicarb

Concentrate4 Liter to 10 Liter Pakistan Yes Yes N/A Yes Yes Yes No Yes Yes No N/A Yes Yes Yes No Yes Yes Yes Yes No No Yes N/A Yes Yes Yes Yes Yes Yes N/A

Not-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

3. The firm did not attach Form-29 issued by

SECP. /Form C / sole proprietorship.

4. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

2AKRAM

BROTHERS & CO10

Black Silk, Size

2/0,60mm straight

cutting needle

12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO Black

Braided Silk

Suture

WEGO Black Braided Silk

Suture Size 2/0, 60mm

Straight Cutting Needle

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

3AKRAM

BROTHERS & CO11

Black Silk, Size 1, 30mm,

1/2Circle round body

needle

12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO Black

Braided Silk

Suture

WEGO Black Braided Silk

Suture Size 1, 30mm 1/2

Circle Round Body Needle

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

4AKRAM

BROTHERS & CO12

Black Silk, Size1,40mm

3/8 Circle curve cutting

(CC) needle

12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO Black

Braided Silk

Suture

WEGO Black Braided Silk

Suture Size 1, 40mm 3/8

Circle Curved Cutting

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5AKRAM

BROTHERS & CO13

Black Silk,2/0,30mm 1/2

circle round body

needle

12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO Black

Braided Silk

Suture

WEGO Black Braided Silk

Suture 2/0, 30mm 1/2 Circle

Round Body

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

6AKRAM

BROTHERS & CO18

Catgut Chromic, Size 1,

with 40mm Intestinal RB

Needle

12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO Chromic

Catgut

WEGO Chromic Catgut Size

1, 40mm 1/2 Circle Round

Body

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

7AKRAM

BROTHERS & CO19

Catgut Chromic, Size

1,30mm, ½ Circle RB

Needle

12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO Chromic

Catgut

WEGO Chromic Catgut Size

1, 30mm 1/2 Circle Round

Body

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

8AKRAM

BROTHERS & CO20

Catgut Chromic, Size

1,40mm, curved Needle 12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO Chromic

Catgut

WEGO Chromic Catgut Size

1, 40mm Curved Cutting

Needle

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

9AKRAM

BROTHERS & CO21

Catgut Chromic, Size2/0

,30mm, 1/2 Circle Round

Body needle

12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO Chromic

Catgut

WEGO Chromic Catgut Size

2/0, 30mm 1/2 Circle Round

Body

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

10AKRAM

BROTHERS & CO49

Poly propylene Size 1,

40mm 1/2 circle RB

Needle

12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO Prolene

Polypropylene

WEGO Prolene

Polypropylene 1, 40mm 1/2

Circle Round Body

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

11AKRAM

BROTHERS & CO50

Poly propylene, Size 2/0,

30mm 1/2 circle RB

Needle

12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO Prolene

Polypropylene

WEGO Prolene

Polypropylene Size 2/0,

30mm 1/2 Circle Round

Body

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

12AKRAM

BROTHERS & CO51

Poly propylene, Size

2/0,60mm Straight

Cutting needle (SCN)

12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO Prolene

Polypropylene

WEGO Prolene

Polypropylene 2/0, 60,,

Staright Cutting

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

13AKRAM

BROTHERS & CO52

Polyglactin/ Polyglycolic

acid, Size 1,40mm.1/2

Circle Round Body

needle

12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO PGA

Polyglycolic

Acid/ WEGO

PGLA Poly Lactic

co Glycolic Acid

WEGO PGA Polyglycolic

Acid/WEGO PGLA Poly

Lactic co Glycolic Acid Size

1, 40mm 1/2 Circle Round

Body

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

14AKRAM

BROTHERS & CO53

Polyglactin/ Polyglycolic

acid, size 2/0,30mm, 1/2

Circle Round Body

needle

12

WEGO

Sutures

Foosin

Medical

Supplies

Inc. Ltd.

WEGO PGA

Polyglycolic

Acid/ WEGO

PGLA Poly Lactic

co Glycolic Acid

WEGO PGA Polyglycolic

Acid/ WEGO PGLA Poly

Lactic co Glycolic Acid 2/0,

30mm 1/2 Circle Round

Body

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

15AL-HAMD

ENTERPRISES34

Examination Gloves

Latex (S.M.L) 100

Tan Sin

Lian

Industrie

s Sdn Bhd

Optishield S,M.L Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

Page 1 of 29

Page 2: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

16AL-HAMD

ENTERPRISES39

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 18G

50

Farcomak

e for

Advance

d Medical

Industrie

s

Farcocathe 18G Egypt Yes Yes Yes Yes Yes N/A Yes Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

4. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

17AL-HAMD

ENTERPRISES40

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 20G

50

Farcomak

e for

Advance

d Medical

Industrie

s

Farcocathe 20G Egypt Yes Yes Yes Yes Yes N/A Yes Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

4. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

18AL-HAMD

ENTERPRISES41

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 22G

50

Farcomak

e for

Advance

d Medical

Industrie

s

Farcocathe 22G Egypt Yes Yes Yes Yes Yes N/A Yes Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

4. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

19AL-HAMD

ENTERPRISES42

I.V Cannula

with/without Injection

Port with Integrated

Closing Cone Sterile Pack

24G

50

Farcomak

e for

Advance

d Medical

Industrie

s

Farcocathe 24G Egypt Yes Yes Yes Yes Yes N/A Yes Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

4. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

20AL-HAMD

ENTERPRISES56

Sterile Surgical Gloves

Pairs 6 ½, 7, 7 ½

(Powdered)

50

Suzhou

Colour-

way New

Material

Co., Ltd

Surgitex 6.5, 7, 7.5 China Yes Yes Yes Yes Yes N/A Yes Yes Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

21

Ali Gohar &

Company

(Private)

Limitted

55Spinal Needle Sterile

Packs All Sizes 1

Smiths

Medical

Internati

onal,

United

Kingdom

Portex 25G, 26G, 27GUnited

StatesYes Yes No Yes Yes N/A Yes Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes No No No No No No No No

Not-

Prequalified

1. The firm did not attach valid sole agency

certificate for the quoted item for at least 1

year till the submisssion of PQ application.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach undertakings for

the clause no.6, 7,8,9 & 10 of the product

wise knockdown criteria of prequalification

document.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

22Amson Vaccines

and Pharma

(Private) Ltd

28Disposable syringe 10ml

with needle. (Blister

pack)

100

Amson

Vaccines

and

Pharma

(Pvt) Ltd.

Islamaba

d,

Pakistan

Apple

Disposable

Syringe 10ml

10 Pakistan Yes N/A N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes Yes N/A Prequalified

Page 2 of 29

Page 3: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

23ASTO Life

Sciences Private

Limited

28Disposable syringe 10ml

with needle. (Blister

pack)

100

Becton

Dickinson

Holdings

Pte Ltd

BD 10ML Singapore Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

24ASTO Life

Sciences Private

Limited

55Spinal Needle Sterile

Packs All Sizes 25

Becton

Dickinson

S.A

BD All Sized Spain Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

25B. Braun

Pakistan Private

Limited

22CVP Line (Double

Lumen) (All Sizes) 1

B.Braun

Melsunge

n AG

CERTOFIX DUO

S 72016|16 Germany Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

26B. Braun

Pakistan Private

Limited

23CVP Line (Triple Lumen)

(All Sizes) 1

B.Braun

Melsunge

n AG

CERTOFIX TRIO

S 72016|16 Germany Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

27B. Braun

Pakistan Private

Limited

27Disposable Insulin

Syringe 1ml with needle

(Blister Pack)

1B.Braun

Melsunge

n AG

OMNICAN 1CC Germany Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

28B. Braun

Pakistan Private

Limited

39

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 18G

1

B.Braun

Medical

Industrie

s SDN

BHD

VASOFIX 18G 18G Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

29B. Braun

Pakistan Private

Limited

40

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 20G

1

B.Braun

Medical

Industrie

s SDN

BHD

VASOFIX 20G 20G Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

30B. Braun

Pakistan Private

Limited

41

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 22G

1

B.Braun

Medical

Industrie

s SDN

BHD

VASOFIX 22G 22G Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

31B. Braun

Pakistan Private

Limited

42

I.V Cannula

with/without Injection

Port with Integrated

Closing Cone Sterile Pack

24G

1

B.Braun

Medical

Industrie

s SDN

BHD

INTROCAN -W

24G IV Cannula24G Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

32B. Braun

Pakistan Private

Limited

43I.V. Sets Sterile blister

Pack 1

B.Braun

Melsunge

n AG

Intrafix

Primeline180 CM Germany Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

33B. Braun

Pakistan Private

Limited

55Spinal Needle Sterile

Packs All Sizes 1

B.Braun

Medical

Industrie

s SDN

BHD

SPINOCAN

18G,20G,22G,23

G,25G,26G,27G

18G,20G,22G,23G,25G,26G,

27GMalaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

34B. Braun

Pakistan Private

Limited

61Three-way stopper with

Tubing  1

B.Braun

Melsunge

n AG

Discofix 3 Blue

With 10cm

Tubing LL

10 CM Tubing Germany Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

35B. Braun

Pakistan Private

Limited

62Three-way stopper

without Tubing  1

B.Braun

Melsunge

n AG

Discofix 3-way

stopcock Blue LL3 SC Germany Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

36Bio Pharma

International17 Caps Surgical 100

ZHEJIANG

RUNLAB

TECHNAL

OGY

Co,LTD

No 6

Minghui

road

Xinqian

street,Hu

angyan

318020,T

aizhou,Zh

ejiang

China

Disposable

Surgical Cap100 pcs pkt China Yes Yes Yes Yes No N/A No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No No No Yes No No No No No No No

Not-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach valid Device

Enlistment certificate of the quoted item.

6. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach undertakings for

the clause no. 3, 6, 7,8,9 & 10 of the product

wise knockdown criteria of prequalification

document.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 3 of 29

Page 4: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

37Bio Pharma

International35 Face Mask Surgical 50

ZHEJIANG

RUNLAB

TECHNAL

OGY

Co,LTD

No 6

Minghui

road

Xinqian

street,Hu

angyan

318020,T

aizhou,Zh

ejiang

China

Disposable

Medical Mask50 pcs pkt 17.5cmX9.5cm China Yes Yes Yes Yes No N/A No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No No No Yes No No No No No No No

Not-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach valid Device

Enlistment certificate of the quoted item.

6. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach undertakings for

the clause no. 3, 6, 7,8,9 & 10 of the product

wise knockdown criteria of prequalification

document.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

38CABBOT

SURGICALS 35 Face Mask Surgical 51

CABBOT

SURGICA

LS

SECURE EACH Pakistan Yes Yes N/A Yes No No No Yes Yes No N/A No Yes Yes No Yes Yes Yes Yes No No Yes N/A No No No No No No N/ANot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

4. The firm did not attach authenticated

building fitness certificate.

5. The firm did not attach Form-29 issued by

SECP. /Form C / sole proprietorship.

6. The firm did not attach valid Device

Enlistment certificate of the quoted item.

7. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

8. The firm did not attach undertakings for

the clause no. 6, 7,8,9 & 10 of the product

wise knockdown criteria of prequalification

document.

39DKT Pakistan

Private Limited45

IUCD (CU-T 380A)

UNFPA/WHO

Prequalified

50

Injeflex

Industria

e

Comercio

De

Heer 50 Brazil Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

40DKT Pakistan

Private Limited46

Male Latex Condom

(UNFPA/WHO

prequalified)

144

Thai

Nippon

Rubber

Industry

Public

Limited

Josh 144 Thailand Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes No Yes Yes Yes Yes Yes NONot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

41EASTERN

MEDICAL CARE

PVT LTD

34Examination Gloves

Latex (S.M.L) 100

ASAP

Internati

onal Sdn.

Bhd, No.

1Jalan

Sitar

33/6,

Seksyen

33 Shah

Alam,

Selangor,

40400,

Malaysia

ASAP S.M.L Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

42

Fresenius

Medical Care

Pakistan (Pvt.)

Ltd

38

Hollow Fiber Dialyzer

(All Sizes) Individually

Sterile Packed (with BTL

and A.V Fistula Needle

Pair)

1

Fresenius

Medical

Care AG

& Co.

KGaA -

61346

Bad

Homburg

,

Germany

Fresenius

Low Flux Dialyzer FX8

Surface Area 1.4m2, FX10

Surface Area 1.8m2 & FX5

Surface Area 1.0m2 with

Blood Tubing Line 6.5mm

with one transducer

protector (Fluid Barrier) &

pre-pump arterial pressure

monitoring line AND Fistula

Needle with fixed wing

16G/17G (Pair)

Germany Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

Page 4 of 29

Page 5: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

43

Fresenius

Medical Care

Pakistan (Pvt.)

Ltd

7

AV Fistula Needles

(Arterial+ venous) with

fixed wings. (Individually

Sterile Packed) size

16/17G.

1

Fresenius

Medical

Care AG

& Co.

KGaA

61346

Bad

Homburg

Germany

Fresenius

Fistula Needle (Arterial

+Venous) with fixed wing

16G/17G (Pair)

Thailand Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

44

Fresenius

Medical Care

Pakistan (Pvt.)

Ltd

8

AV Set Blood Tubing

Lining with one

transducer protector

(Fluid Barrier) & Pre-

Pump Arterial Pressure

Monitoring Line

(Individually Sterile

Packed).

1

Fresenius

Medical

Care AG

& Co.

KGaA

61346

Bad

Homburg

Germany

Fresenius

Blood Tubing Line 6.5mm

with one transducer

protector (Fluid Barrier) &

pre-pump arterial pressure

monitoring line

China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

45Greenstar Social

Marketing 46

Male Latex Condom

(UNFPA/WHO

prequalified)

20

Karex

Industrie

s kuala

lumpur,

Malaysia

Sathi N/A Malaysia Yes Yes No No Yes N/A Yes No No Yes Yes N/A N/A No N/A No Yes No Yes Yes No No No No No No No No No NoNot-

Prequalified

1. The firm did not attach valid sole agency

certificate for the quoted item.

2. The firm did not attach undertakings for

the clause no.4,8,9,14,16 & 18 of the firm

wise knockdown criteria of prequalification

document.

3. The firm did not attach valid Device

Enlistment certificate of the quoted item.

4. The firm did not attach undertakings for

the clause no. 3,6, 7,8,9 & 10 of the product

wise knockdown criteria of prequalification

document.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

46Hakimsons

(Private)

Limited

25Disposable Airways

Sterile Blister Pack (All

sizes)

50

Ningbo

Mflab

Medical

Instrume

nts Co.,

Ltd.

Foyomed 00,0,1,2, 3,4,5 China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach valid Device

Enlistment certificate of the quoted item.

47Hakimsons

(Private)

Limited

32Endotracheal tube (all

sizes) Sterile Packs with

cuff Set

100

Ningbo

Mflab

Medical

Instrume

nts Co.,

Ltd.

Foyomed 2.5 to 8.5 China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach valid Device

Enlistment certificate of the quoted item.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

48Hakimsons

(Private)

Limited

33Endotracheal tube (all

sizes) Sterile Packs

without cuff Set

100

Ningbo

Mflab

Medical

Instrume

nts Co.,

Ltd.

Foyomed 2.5 to 7.0 China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

49Hakimsons

(Private)

Limited

43I.V. Sets Sterile blister

Pack 50

Jiangsu

Suyun

Medical

Materials

Co., Ltd.

Suyun 150cm China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

50Hakimsons

(Private)

Limited

47Nasogastric tube (all

sizes) Sterile Packs 40

Ningbo

Mflab

Medical

Instrume

nts Co.,

Ltd.

Foyomed 4 to 20 Fr China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach valid Device

Enlistment certificate of the quoted item.

51Hakimsons

(Private)

Limited

48Nelton Catheter Sterile

Packs 400

Jiangsu

Suyun

Medical

Materials

Co., Ltd.

Suyun 8 to 24Fr China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

52Hakimsons

(Private)

Limited

58Sterilized Surgical Blades

Sterile Packs All Sizes 100

Ningbo

Mflab

Medical

Instrume

nts Co.,

Ltd.

Foyomed 10,11,15,20,21,22,23,24 China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach valid Device

Enlistment certificate of the quoted item.

53Hakimsons

(Private)

Limited

59Suction Catheter (All

Sizes) 100

Ningbo

Mflab

Medical

Instrume

nts Co.,

Ltd.

Foyomed 6 to 20Fr China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

"1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach valid Device

Enlistment certificate of the quoted item."

Page 5 of 29

Page 6: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

54Hakimsons

(Private)

Limited

63Urine Bags Sterile

(2000ml) Packs 100

Ningbo

Mflab

Medical

Instrume

nts Co.,

Ltd.

Foyomed 2000ml China Yes Yes Yes Yes No N/A No Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes No No Yes Yes Yes Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

55Hakimsons

(Private)

Limited

64Volumetric Chamber (I.V

Burette) Sterile Packs

100ml size

100

Ningbo

Mflab

Medical

Instrume

nts Co.,

Ltd.

Foyomed 100ml China Yes Yes Yes Yes No N/A No Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes No No Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

56Hashir Surgical

Services 34

Examination Gloves

Latex (S.M.L) 100

N.A.Z

Medical

Supplies

Sdn., Bhd

NAZCARE SMALL, MEDIUM, LARGE Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

57Hashir Surgical

Services 35 Face Mask Surgical 50

Shenggua

ng

Medical

Instrume

nt Co.,

Ltd.

SHENGGUANG 17.5CMX9.5CM China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

58Hashir Surgical

Services 37

Foley’s catheter (all

sizes) Sterile Packs All

sizes

10

Jiangxi

Fenglin

Medical

Technolo

gy Co.,

Ltd.

urocath6FR,8FR,10FR,12FR,14FR,16

FR,18FR,20FRChina Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

59Hashir Surgical

Services 39

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 18G

50

USM

Healthcar

e Medical

Devices

Factory

JSC

FAVOCATH G18 Vietnam Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

60Hashir Surgical

Services 40

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 20G

50

USM

Healthcar

e Medical

Devices

Factory

JSC

FAVOCATH 20G Vietnam Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

61Hashir Surgical

Services 41

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 22G

50

USM

Healthcar

e Medical

Devices

Factory

JSC

FAVOCATH 22G Vietnam Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

62Hashir Surgical

Services 42

I.V Cannula

with/without Injection

Port with Integrated

Closing Cone Sterile Pack

24G

50

USM

Healthcar

e Medical

Devices

Factory

JSC

FAVOCATH G24 Vietnam Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

63Hashir Surgical

Services 43

I.V. Sets Sterile blister

Pack 50

Jiangxi

Fenglin

Medical

Applianc

es Co.,

Ltd.

BIOSOFT 150 Pakistan Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

64Hashir Surgical

Services 55

Spinal Needle Sterile

Packs All Sizes 20

Meditop

Corporati

on

(Malaysia

) Sdn.

Bhd. (A

wholly

owned

subsidiar

y of TOP

Corporati

on Japan

TOP18G,20G,21G,22G,23G,25G,

27GMalaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

65Hashir Surgical

Services 58

Sterilized Surgical Blades

Sterile Packs All Sizes 100

TRINON

Titanium

GmbH

TRINON Size.11, 15, 20, 21, 22, 23 Germany Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

Page 6 of 29

Page 7: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

66Hashir Surgical

Services 63

Urine Bags Sterile

(2000ml) Packs 10

Jiangsu

Kangjin

Medical

Instrume

nts Co.,

Ltd

BIO BAG 2000ML China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

67Hashir Surgical

Services 64

Volumetric Chamber (I.V

Burette) Sterile Packs

100ml size

10

Jiangxi

Fenglin

Medical

Applianc

es Co.,

Ltd.

BIOSOFT 100ML China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

68Hospital Supply

Corporation24

Double Lumen catheter

for Haemodialysis 5

Bioteque

Corporati

on

BIOTEQ Standard Taiwan Yes Yes Yes Yes Yes N/A No Yes Yes Yes No N/A N/A No N/A No Yes No Yes No No Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach undertaking for

the clause no.14, 16 & 18 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

69Hospital Supply

Corporation27

Disposable Insulin

Syringe 1ml with needle

(Blister Pack)

100

Shanghai

Kindly

Enterpris

es

Develop

ment

Group

Co., Ltd.

China

YMS 1cc China Yes Yes Yes Yes No N/A Yes Yes Yes Yes No N/A N/A No N/A No Yes No Yes Yes No Yes Yes No Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach undertaking for

the clause no.14, 16 & 18 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

70Hospital Supply

Corporation28

Disposable syringe 10ml

with needle. (Blister

pack)

100

Shanghai

Kindly

Enterpris

es

Develop

ment

Group

Co., Ltd.

China

YMS 10 CC China Yes Yes Yes Yes No N/A Yes Yes Yes Yes No N/A N/A No N/A No Yes No Yes Yes No Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach undertaking for

the clause no.14, 16 & 18 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

71Hospital Supply

Corporation29

Disposable Syringe 20ml

with needle. (Blister

pack)

100

Shanghai

Kindly

Enterpris

e

Develop

ment Ltd.

China

YMS 20 CC China Yes Yes Yes Yes No N/A Yes Yes Yes Yes No N/A N/A No N/A No Yes No Yes Yes No Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach undertaking for

the clause no.14, 16 & 18 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

72Hospital Supply

Corporation43

I.V. Sets Sterile blister

Pack 25

shanghai

kindly

enterpris

e

develop

ment

group

co., ltd

YMS Standard China Yes Yes Yes Yes No N/A Yes Yes Yes Yes No N/A N/A No N/A No Yes No Yes Yes No Yes Yes No Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach undertaking for

the clause no.14, 16 & 18 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

Page 7 of 29

Page 8: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

73Hospital Supply

Corporation54

Scalp Vein Set Sterile

Packs (All Sizes) 50

shanghai

kindly

enterpris

e

develop

ment

group

co., ltd

YMS 20, 22, 24 China Yes Yes Yes Yes No N/A Yes Yes Yes Yes No N/A N/A No N/A No Yes No Yes Yes No Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach undertaking for

the clause no.14, 16 & 18 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

74Hospital Supply

Corporation63

Urine Bags Sterile

(2000ml) Packs 10

Shanghai

Kindly

Enterpris

es

Develop

ment

Group

Co., Ltd.

China

YMS 2000 China Yes Yes Yes Yes No N/A Yes Yes Yes Yes No N/A N/A No N/A No Yes No Yes Yes No Yes Yes No Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach undertaking for

the clause no.14, 16 & 18 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

75Hospital Supply

Corporation64

Volumetric Chamber (I.V

Burette) Sterile Packs

100ml size

10

Shanghai

Kindly

Enterpris

e

Develop

ment Ltd.

China

YMS 100 China Yes Yes Yes Yes No N/A Yes Yes Yes Yes No N/A N/A No N/A No Yes No Yes Yes No Yes Yes No Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach undertaking for

the clause no.14, 16 & 18 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

76Hospital Supply

Corporation7

AV Fistula Needles

(Arterial+ venous) with

fixed wings. (Individually

Sterile Packed) size

16/17G.

600Bioteque

Corporati

on

BIOTEQ 16, 17 Taiwan Yes Yes Yes Yes Yes N/A No Yes Yes Yes No N/A N/A No N/A No Yes No No Yes No Yes Yes No Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach undertaking for

the clause no.14, 16 & 18 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

77Hospital Supply

Corporation8

AV Set Blood Tubing

Lining with one

transducer protector

(Fluid Barrier) & Pre-

Pump Arterial Pressure

Monitoring Line

(Individually Sterile

Packed).

24Bioteque

Corporati

on

BIOTEQ Standard Taiwan Yes Yes Yes Yes Yes N/A No Yes Yes Yes No N/A N/A No N/A No Yes No No Yes No Yes Yes No Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach undertaking for

the clause no.14, 16 & 18 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach valid Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

78IBL

HEALTHCARE

LIMITED

14Blood Bags Sterile Packs

250ml single 100

Shandon

g Weigao

Group

Medical

Polymer

Co. Ltd

WEGO 5 Bags in a pouch China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No No Yes No Yes Yes NoNot-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach undertakings for

the clause no.6, & 8 of the product wise

knockdown criteria of prequalification

document.

4. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 8 of 29

Page 9: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

79IBL

HEALTHCARE

LIMITED

15Blood Bags Sterile Packs

500ml single 100

Shandon

g Weigao

Group

Medical

Polymer

Co. Ltd

WEGO 5 BAGS IN ONE POUCH China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes No Yes Yes NoNot-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach undertakings for

the clause no.6, & 8 of the product wise

knockdown criteria of prequalification

document.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

80IBL

HEALTHCARE

LIMITED

16Blood Transfusion Set

Sterile Packs 400

Ultra for

medical

products-

Ultramed

Ultramed single Egypt Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes No Yes No Yes No Yes Yes YesNot-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach valid sole agency

certificate for the quoted item.

3. The firm did not attach undertakings for

the clause no.6, & 8 of the product wise

knockdown criteria of prequalification

document.

81IBL

HEALTHCARE

LIMITED

38

Hollow Fiber Dialyzer

(All Sizes) Individually

Sterile Packed (with BTL

and A.V Fistula Needle

Pair)

1

Suzhou

ZOEY

Medical

Devices

Co. Ltd.

Hollow Fiber

Hemodialyzer

Hollow Fiber Hemodialyzer,

Low Flux / 1.4, 1.6, 1.8, 2.0China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes No Yes No Yes Yes No

Not-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach valid Device

Enlistment certificate of the quoted item.

3. The firm did not attach undertakings for

the clause no.6, & 8 of the product wise

knockdown criteria of prequalification

document.

4. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

82IBL

HEALTHCARE

LIMITED

43I.V. Sets Sterile blister

Pack 500

Shandon

g Weigao

Group

Medical

Polymer

Co. Ltd

WEGO Single China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No No Yes No Yes Yes YesNot-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach undertakings for

the clause no.6, & 8 of the product wise

knockdown criteria of prequalification

document.

83IBL

HEALTHCARE

LIMITED

63Urine Bags Sterile

(2000ml) Packs 250

Ultra for

medical

products-

Ultramed

Ultramed Single Egypt Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes No No Yes No Yes Yes NoNot-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach undertakings for

the clause no.6, & 8 of the product wise

knockdown criteria of prequalification

document.

4. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

84 intra health 16Blood Transfusion Set

Sterile Packs 300

WEIFANG

KAWA

MEDICAL

PRODUCT

S CO.LTD

Unison 18Gx1½ China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

85 intra health 33Endotracheal tube (all

sizes) Sterile Packs

without cuff Set

10Flexicare

Medical

Limited

VentiSeal 2.5, 3.0, 3.5, 4.0, 4.5United

KingdomYes Yes Yes Yes No N/A No Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

4. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

86 intra health 34Examination Gloves

Latex (S.M.L) 100

Terang

NusaNugard Small, Medium, Large Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

87 intra health 43I.V. Sets Sterile blister

Pack 500

WEIFANG

KAWA

MEDICAL

PRODUCT

S CO.LTD

Unison 185 cm China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

88 intra health 44Instrumental

Disinfectant Solution Of

appropriate composition

6

ANTISEPT

ICA

DR.HANS

JOACHIM

MOLITOR

GMBH

Combi

Instruments N1 Liter Germany Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach Purchase Orders

of quoted item for the last three

consecutive years.

Page 9 of 29

Page 10: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

89 intra health 44Instrumental

Disinfectant Solution Of

appropriate composition

6

ANTISEPT

ICA

DR.HANS

JOACHIM

MOLITOR

GMBH

Triacid N 1 Liter Germany Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

90 intra health 56Sterile Surgical Gloves

Pairs 6 ½, 7, 7 ½

(Powdered)

50Terang

NusaMaxitex 6.5, 7.0, 7.5 Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

91 intra health 60Surface Disinfectant

Solution Of appropriate

composition

6

ANTISEPT

ICA

DR.HANS

JOACHIM

MOLITOR

GMBH

Biguacid S 1 Liter Germany Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

92 intra health 60Surface Disinfectant

Solution Of appropriate

composition

6

ANTISEPT

ICA

DR.HANS

JOACHIM

MOLITOR

GMBH

Descocid N 1 Liter Germany Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

93 intra health 61Three-way stopper with

Tubing  40

WEIFANG

KAWA

MEDICAL

PRODUCT

S CO.LTD

Kawa with Tubing China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

94 intra health 62Three-way stopper

without Tubing  40

WEIFANG

KAWA

MEDICAL

PRODUCT

S CO.LTD

Kawa without tubing China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

95 intra health 64Volumetric Chamber (I.V

Burette) Sterile Packs

100ml size

100

WEIFANG

KAWA

MEDICAL

PRODUCT

S CO.LTD

Unison 60 Drops / ml China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

96 Iqbal and

Company22 CVP Line (Double

Lumen) (All Sizes) 10 Medcom

pMedcomp USA All Sizes

United

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

97 Iqbal and

Company23 CVP Line (Triple Lumen)

(All Sizes) 10 Medcom

pMedcomp USA All sizes

United

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

98 Iqbal and

Company24 Double Lumen catheter

for Haemodialysis 10 Medcom

pMedcomp USA All sizes

United

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

99KM

ENTERPRISES27

Disposable Insulin

Syringe 1ml with needle

(Blister Pack)

100

Changzho

u Medical

Applianc

es

General

Factory

Co,Ltd

AMD 100IU China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

100KM

ENTERPRISES28

Disposable syringe 10ml

with needle. (Blister

pack)

100

Changzho

u Medical

Applianc

es

General

Factory

Co,Ltd

AMD 10ml China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

101KM

ENTERPRISES29

Disposable Syringe 20ml

with needle. (Blister

pack)

50

Changzho

u Medical

Applianc

es

General

Factory

Co,Ltd

AMD 20ml China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

102KM

ENTERPRISES34

Examination Gloves

Latex (S.M.L) 100

BioMax

Rubber

Industrie

s SDN

BHD

Malaysia

BioMax all size Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

103KM

ENTERPRISES34

Examination Gloves

Latex (S.M.L) 100

SUPER

MAX

GLOVES

MANUFA

CTRING

SDN BDH

Maxpro all size Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

104KM

ENTERPRISES35 Face Mask Surgical 50

Changzho

u Medical

Applianc

es

General

Factory

Co,Ltd

AMD standred China Yes Yes Yes Yes No N/A No Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO

13485.Submitted certificate is

forged/edited/fake.The scope mentioned

on online website of issuaing organization

(TUV Rheinland) is different from certificate

submitted in the bid.face mask is

mentioned in submitted certificate while

online certificate does not contain face

mask in its scope.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3.The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 10 of 29

Page 11: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

105KM

ENTERPRISES37

Foley’s catheter (all

sizes) Sterile Packs All

sizes

1

Euromed

of

medical

industrie

s

EURO Flow-

Foley Catheterall size Egypt Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

3.The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

106KM

ENTERPRISES39

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 18G

100

Euromed

of

medical

industrie

s

EURO FLOW

I.V.Cannula18G Egypt Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

107KM

ENTERPRISES40

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 20G

100

Euromed

of

medical

industrie

s

EURO FLOW IV

CANNULA20G Egypt Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

108KM

ENTERPRISES41

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 22G

100

Euromed

of

medical

industrie

s

EURO FLOE IV

CANNULA22G Egypt Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

109KM

ENTERPRISES42

I.V Cannula

with/without Injection

Port with Integrated

Closing Cone Sterile Pack

24G

100

Euromed

of

medical

industrie

s

EURO FLOW IV

CANULLA24G Egypt Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

110KM

ENTERPRISES43

I.V. Sets Sterile blister

Pack 25

Changzho

u Medical

Applianc

es

General

Factory

Co,Ltd

AMD standred China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

111KM

ENTERPRISES63

Urine Bags Sterile

(2000ml) Packs 25

Changzho

u Medical

Applianc

es

General

Factory

Co,Ltd

AMD standred size China Yes Yes Yes Yes No N/A No Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes No No Yes Yes Yes Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach valid Device

Enlistment certificate of the quoted item. 4.

The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 11 of 29

Page 12: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

112KM

ENTERPRISES64

Volumetric Chamber (I.V

Burette) Sterile Packs

100ml size

1

Changzho

u Medical

Applianc

es

General

Factory

Co,Ltd

AMD 100ml China Yes Yes Yes Yes No N/A No Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO

13485.Submitted certificate is

forged/edited/fake.The scope mentioned

on online website of issuaing organization

(TUV Rheinland) is different from certificate

submitted in the bid.Burett infusion set is

mentioned in submitted certificate while

online certificate does not contain burett

infusion set in its scope.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.Submitted certificate is

forged/edited/fake.The scope mentioned

on online website of issuaing organization

(TUV Rheinland) is different from certificate

submitted in the bid.Burett infusion set is

mentioned in submitted certificate while

online certificate does not contain burett

infusion set in its scope

3. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

4. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

5. The firm did not attach valid Device

113Lab Link

Enterprises27

Disposable Insulin

Syringe 1ml with needle

(Blister Pack)

100PT Nipro

Indonesia

Jaya

Nipro Insulin

Syringe30G 5/16 Japan Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

114Lab Link

Enterprises28

Disposable syringe 10ml

with needle. (Blister

pack)

100PT Nipro

Indonesia

Jaya

nipro 21G 1 1/2" Indonesia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

115Lab Link

Enterprises29

Disposable Syringe 20ml

with needle. (Blister

pack)

100PT Nipro

Indonesia

Jaya

Nipro 21G 1 1/2" Japan Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

116Lab Link

Enterprises39

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 18G

50PT Nipro

Indonesia

Jaya

Nipro Wing cath 18G Japan Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

117Lab Link

Enterprises40

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 20G

50PT Nipro

Indonesia

Jaya

Nipro Wing Cath 20G Japan Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

118Lab Link

Enterprises41

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 22G

50PT Nipro

Indonesia

Jaya

Nipro Wing Cath 22G Japan Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

119Lab Link

Enterprises42

I.V Cannula

with/without Injection

Port with Integrated

Closing Cone Sterile Pack

24G

50PT Nipro

Indonesia

Jaya

Nipro Wing Cath 24G Japan Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

120Lab Link

Enterprises43

I.V. Sets Sterile blister

Pack 100

Amsino

Medical

(Shanghai

) Co.,Ltd

AMSINO 165cmUnited

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

121Lab Link

Enterprises54

Scalp Vein Set Sterile

Packs (All Sizes) 50

Nipro

(Thailand

)

Corporati

on

Limited

Nipro Scalp Vein

Set12"/30MM Japan Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

122Lab Link

Enterprises55

Spinal Needle Sterile

Packs All Sizes 25

Nipro

Corporati

on Japan

Nipro Spinal

Needle90mm Japan Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

123Lab Link

Enterprises64

Volumetric Chamber (I.V

Burette) Sterile Packs

100ml size

50

Amsino

Medical

(Shanghai

) Co.,Ltd

Amsino

spike,flow regulator,

burette with cap drip

chammber, fluid filter, tube,

injection port

United

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

124 Lucky Lab 34Examination Gloves

Latex (S.M.L)

Mexpo

Internati

onal

Not mentioned

in the bidUSA Yes Yes No Yes Yes N/A No Yes Yes No No N/A N/A No N/A No Yes Yes No No No No No No No No No No No No

Not-

Prequalified

1. The firm did not attach valid sole agency

certificate for the quoted item. Moreover,

the firm did not mention the brand name

for the quoted item.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach undertaking for

the clause no. 14 16 of the firm wise

knockdown criteria of prequalification

document.

6. The firm did not apply for prequalification

on PQOD portal as per the clause no. 19 of

the firm wise knockdown criteria of

prequalification document.

7. The firm did not attach valid Device

Enlistment certificate of the quoted item.

8. The firm did not attach undertakings for

Page 12 of 29

Page 13: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

125 Lucky Lab 56Sterile Surgical Gloves

Pairs 6 ½, 7, 7 ½

(Powdered)

Mexpo

Internati

onal

Not mentioned

in the bidUSA Yes Yes No Yes Yes N/A No Yes Yes No No N/A N/A No N/A No Yes Yes No No No No No No No No No No No No

Not-

Prequalified

1. The firm did not attach valid sole agency

certificate for the quoted item. Moreover,

the firm did not mention the brand name

for the quoted item.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach undertaking for

the clause no. 14 16 of the firm wise

knockdown criteria of prequalification

document.

6. The firm did not apply for prequalification

on PQOD portal as per the clause no. 19 of

the firm wise knockdown criteria of

prequalification document.

7. The firm did not attach valid Device

Enlistment certificate of the quoted item.

8. The firm did not attach undertakings for

126 M & M Pharma. 45IUCD (CU-T 380A)

UNFPA/WHO

Prequalified

1HLL

Lifecare

Limited.

n/a Cu-T 380A India Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

127 M & M Pharma. 46Male Latex Condom

(UNFPA/WHO

prequalified)

144

Suzhou

Colour-

way New

Material,

Haushi

industry

Park,2144

21

Jiangyin,

China

N/A WHO SPEC China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

128Medinostic

Health Care

(Pvt.) Ltd.

44Instrumental

Disinfectant Solution Of

appropriate composition

1

Medimar

k

Scientific

Limited

ReproDIS N/AUnited

KingdomYes No Yes Yes Yes N/A Yes Yes Yes No Yes N/A Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach valid DSL.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

129Medinostic

Health Care

(Pvt.) Ltd.

60Surface Disinfectant

Solution Of appropriate

composition

1

Medimar

k

Scientific

Limited

ChemGENE N/AUnited

KingdomYes No Yes Yes Yes N/A Yes Yes Yes No Yes N/A Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach valid DSL.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

130 Meher Traders 17 Caps Surgical 100

NINGBO

GREATM

OUNTAIN

MEDICAL

INSTRUM

ENTS CO

LTD

WELLMED Surgical Caps China Yes Yes Yes Yes No Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

7. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 13 of 29

Page 14: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

131 Meher Traders 25Disposable Airways

Sterile Blister Pack (All

sizes)

1

NINGBO

GREATM

OUNTAIN

MEDICAL

INSTRUM

ENTS CO

LTD

WELLMED ALL SIZES China Yes Yes Yes Yes No Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No No Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

6. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

7. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

8. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

132 Meher Traders 32Endotracheal tube (all

sizes) Sterile Packs with

cuff Set

1

Nanchan

g Kaimed

Medical

Apparatu

s Co.,Ltd.

WELLMED All Sizes China Yes Yes Yes Yes No Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

7. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

133 Meher Traders 33Endotracheal tube (all

sizes) Sterile Packs

without cuff Set

1

Nanchan

g Kaimed

Medical

Apparatu

s Co.,Ltd.

WELLMED All Sizes China Yes Yes Yes Yes No Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

7. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

134 Meher Traders 34Examination Gloves

Latex (S.M.L) 100

TG

Medical

Sdn Bhd

WELLMED SML Malaysia Yes Yes Yes Yes No Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

7. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 14 of 29

Page 15: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

135 Meher Traders 35 Face Mask Surgical 50

NINGBO

GREATM

OUNTAIN

MEDICAL

INSTRUM

ENTS CO

LTD

WELLMED Standard Disposable China Yes Yes Yes Yes No Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

7. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

136 Meher Traders 36Face Mask Surgical with

Tie 50

NINGBO

GREATM

OUNTAIN

MEDICAL

INSTRUM

ENTS CO

LTD

Wellmed Disposable Tie China Yes Yes Yes Yes No Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

7. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

137 Meher Traders 37Foley’s catheter (all

sizes) Sterile Packs All

sizes

1

NINGBO

GREATM

OUNTAIN

MEDICAL

INSTRUM

ENTS CO

LTD

WELLMED ALL SIZES China Yes Yes Yes Yes No Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

7. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

138 Meher Traders 47Nasogastric tube (all

sizes) Sterile Packs 1

CHANGZ

HOU

YAPING

MEDICAL

MATERIA

LS

WELLMED ALL SIZES China Yes Yes Yes Yes Yes Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 15 of 29

Page 16: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

139 Meher Traders 48Nelton Catheter Sterile

Packs 1

CHANGZ

HOU

YAPING

MEDICAL

MATERIA

LS

WELLMED STERILE PACK China Yes Yes Yes Yes Yes Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

140 Meher Traders 56Sterile Surgical Gloves

Pairs 6 ½, 7, 7 ½

(Powdered)

1

ANHUI

ANYU

LATEX

PRODUCT

S

WELLMED ALL SIZES China Yes Yes Yes Yes Yes Yes Yes Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

4. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

5. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

141 Meher Traders 57Sterilized Cord Clamps

Sterile Packs 1

NINGBO

GREATM

OUNTAIN

MEDICAL

INSTRUM

ENTS CO

LTD

WELLMED STANDARD SIZE China Yes Yes Yes Yes No Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

7. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

142 Meher Traders 59Suction Catheter (All

Sizes) 1

CHANGZ

HOU

YAPING

MEDICAL

MATERIA

LS

WELLMED ALL SIZES China Yes Yes Yes Yes Yes Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 16 of 29

Page 17: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

143 Meher Traders 61Three-way stopper with

Tubing  1

Suzhou

Health

Plastic

Products

Co., Ltd

WELLMED STOPPER WITH TUBING China Yes Yes Yes Yes No Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

144 Meher Traders 62Three-way stopper

without Tubing  1

Suzhou

Health

Plastic

Products

Co., Ltd

WELLMEDTHREE WAY WITHOUT

STOPPERChina Yes Yes Yes Yes No Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes No

Not-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

7. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

145 Meher Traders 63Urine Bags Sterile

(2000ml) Packs 1

CHANGZ

HOU

YAPING

MEDICAL

MATERIA

LS

WELLMED 2000ML China Yes Yes Yes Yes Yes Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

146 Meher Traders 64Volumetric Chamber (I.V

Burette) Sterile Packs

100ml size

1

Hunan

Luzhou

Huikang

Develop

ment

Co.,Ltd.

China

WELLMED 100ML China Yes Yes Yes Yes No Yes No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No No Yes Yes Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

4. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

7. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 17 of 29

Page 18: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

147Moon

Enterprises34

Examination Gloves

Latex (S.M.L) 100

AXG

Industrie

s SDN

BHD

AXGlove 6 Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes No No N/A Yes Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

2. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

3. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

148Nipro Medical

Pvt Ltd24

Double Lumen catheter

for Haemodialysis 60

Shunmei

Medical

Co., Ltd

Hemodialysis

Catheter Kits

12Fr x 15 cm Straight/ 12Fr

x 16 cm Straight/ 12Fr x 15

cm Curved/ 12Fr x 20 cm

Straight/ 8.5 Fr x 11 cm

Straight/ 8.5 Fr x 12 cm

Straight

China Yes Yes Yes Yes Yes N/A Yes Yes Yes No Yes N/A N/A No N/A No Yes Yes Yes Yes No Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

2. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

3. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

149Nipro Medical

Pvt Ltd38

Hollow Fiber Dialyzer

(All Sizes) Individually

Sterile Packed (with BTL

and A.V Fistula Needle

Pair)

24Nipro

Corporati

on Japan

Elisio 1.1/ 1.3/ 1.5/ 1.7/ 1.9/ 2.1 Japan Yes Yes Yes Yes Yes N/A Yes Yes Yes No Yes N/A N/A No N/A No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

2. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

150Nipro Medical

Pvt Ltd7

AV Fistula Needles

(Arterial+ venous) with

fixed wings. (Individually

Sterile Packed) size

16/17G.

25PT. Nipro

Indonesia

JAYA

Nipro AVF 16G/17G Indonesia Yes Yes Yes Yes Yes N/A Yes Yes Yes No Yes N/A N/A No N/A No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

2. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

151Nipro Medical

Pvt Ltd8

AV Set Blood Tubing

Lining with one

transducer protector

(Fluid Barrier) & Pre-

Pump Arterial Pressure

Monitoring Line

(Individually Sterile

Packed).

30

Ningbo

Tianyi

Medical

Applianc

e Co., Ltd

Nipro

Extracorporeal

Blood Circuit

6.4mm China Yes Yes Yes Yes Yes N/A Yes Yes Yes No Yes N/A N/A No N/A No Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

2. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

3. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

4. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

152 Nisa . SF 16Blood Transfusion Set

Sterile Packs 25

Nisa.SF

(Pvt) LtdBM 18G Needle Size Pakistan Yes N/A N/A Yes Yes No No Yes Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes N/A No Yes Yes Yes Yes Yes N/A

Not-

Prequalified

1. The firm did not attach valid GMP

certificate.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

153 Nisa . SF 28Disposable syringe 10ml

with needle. (Blister

pack)

1Nisa.SF

(Pvt) LtdBM 10cc Pakistan Yes N/A N/A Yes Yes No No Yes Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes Yes N/A

Not-

Prequalified

1. The firm did not attach valid GMP

certificate.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

154 Nisa . SF 29Disposable Syringe 20ml

with needle. (Blister

pack)

50Nisa.SF

(Pvt) LtdBM 20cc Pakistan Yes N/A N/A Yes Yes No No Yes Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes Yes N/A

Not-

Prequalified

1. The firm did not attach valid GMP

certificate.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

Page 18 of 29

Page 19: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

155 Nisa . SF 43I.V. Sets Sterile blister

Pack 25

Nisa.SF

(Pvt) LtdBM 150 CM Pakistan Yes N/A N/A Yes Yes No No Yes Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes N/A No Yes Yes Yes Yes Yes N/A

Not-

Prequalified

1. The firm did not attach valid GMP

certificate.

2. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

3. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

156Nisa Impex

(Private)

Limited

16Blood Transfusion Set

Sterile Packs 25

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA 18G Needle Size China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes No No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach valid sole agency

certificate for the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3.The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

157Nisa Impex

(Private)

Limited

27Disposable Insulin

Syringe 1ml with needle

(Blister Pack)

100

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA 1cc China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

158Nisa Impex

(Private)

Limited

28Disposable syringe 10ml

with needle. (Blister

pack)

100

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA 10cc China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

159Nisa Impex

(Private)

Limited

29Disposable Syringe 20ml

with needle. (Blister

pack)

50

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA 20cc China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

160Nisa Impex

(Private)

Limited

30Disposable Syringe 50ml

with needle. (Blister

pack)

25

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA50cc 50cc China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

161Nisa Impex

(Private)

Limited

31

Disposable Syringe 60ml

with Central Nozzle or

Catheter Tip (Blister

Pack)

25

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA 60cc China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

162Nisa Impex

(Private)

Limited

35 Face Mask Surgical 50

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA 3 Ply Medical Grade China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

The firm did not attach Purchase orders and

GDs certificates for quoted item for atleast

last three consective years

163Nisa Impex

(Private)

Limited

39

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 18G

50

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA 18G Pakistan Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes No No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach valid sole agency

certificate for the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3.The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

164Nisa Impex

(Private)

Limited

40

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 20G

50

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA 20G China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes No No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach valid sole agency

certificate for the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3.The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

165Nisa Impex

(Private)

Limited

41

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 22G

50

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA 22G China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes No No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach valid sole agency

certificate for the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3.The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 19 of 29

Page 20: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

166Nisa Impex

(Private)

Limited

42

I.V Cannula

with/without Injection

Port with Integrated

Closing Cone Sterile Pack

24G

50

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA 24G China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes No No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach valid sole agency

certificate for the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3.The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

167Nisa Impex

(Private)

Limited

43I.V. Sets Sterile blister

Pack 1

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA 150 CM China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

168Nisa Impex

(Private)

Limited

54Scalp Vein Set Sterile

Packs (All Sizes) 50

Chengdu

Xinjin

Shifeng

Medical

Apparatu

s &

Instrume

nt Co.Ltd

NISA 14G-27G China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes No No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach valid sole agency

certificate for the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3.The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

169Noor

International55

Spinal Needle Sterile

Packs All Sizes 25

UNISIS

CORP.UniEver 18, 20, 22, 23, 25, 27 Japan Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

170Noor

International56

Sterile Surgical Gloves

Pairs 6 ½, 7, 7 ½

(Powdered)

50

KOSSAN

INTERNA

TIONAL

SDN.

BHD. (

iNtouch

Powdered &

Powder free

5.0 to 8.5 Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach valid sole agency

certificate for the quoted item.

171Renacon

Pharma Ltd9

Bicarbonate Solution of

appropriate composition

for hemodialysis

4Renacon

Pharma

Ltd

Renacarb

Concentrate4 Pakistan Yes N/A N/A Yes Yes Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes N/A Yes Yes Yes Yes Yes Yes N/A

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

172Silver Surgical

Complex (Pvt.)

Ltd

39

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 18G

1

Silver

Surgical

Complex

(Pvt.) Ltd,

Karachi,

Pakistan

GREEN 18guage Pakistan Yes N/A N/A No Yes Yes No No No Yes N/A Yes No No Yes No Yes No Yes No Yes No N/A Yes No No No No No N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach undertakings for

the clause no. 4, 8,9, 13, 14, 16 & 18 of the

firm wise knockdown criteria of

prequalification document.

3. The firm did not attach undertakings for

the clause no. 3, 6, 7,8,9 & 10 of the product

wise knockdown criteria of prequalification

document.

173Silver Surgical

Complex (Pvt.)

Ltd

40

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 20G

1

Silver

Surgical

Complex

(Pvt.) Ltd,

Karachi,

Pakistan

GREEN 20guage Pakistan Yes N/A N/A No Yes Yes No No No Yes N/A Yes No No Yes No Yes No Yes No Yes No N/A Yes No No No No No N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach undertakings for

the clause no. 4, 8,9, 13, 14, 16 & 18 of the

firm wise knockdown criteria of

prequalification document.

3. The firm did not attach undertakings for

the clause no. 3, 6, 7,8,9 & 10 of the product

wise knockdown criteria of prequalification

document.

174Silver Surgical

Complex (Pvt.)

Ltd

41

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 22G

1

Silver

Surgical

Complex

(Pvt.) Ltd,

Karachi,

Pakistan

GREEN 22guage Pakistan Yes N/A N/A No Yes Yes No No No Yes N/A Yes No No Yes No Yes No Yes No Yes No N/A Yes No No No No No N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach undertakings for

the clause no. 4, 8,9, 13, 14, 16 & 18 of the

firm wise knockdown criteria of

prequalification document.

3. The firm did not attach undertakings for

the clause no. 3, 6, 7,8,9 & 10 of the product

wise knockdown criteria of prequalification

document.

175Silver Surgical

Complex (Pvt.)

Ltd

42

I.V Cannula

with/without Injection

Port with Integrated

Closing Cone Sterile Pack

24G

1

Silver

Surgical

Complex

(Pvt.) Ltd,

Karachi,

Pakistan

GREEN 24 GAUGE Pakistan Yes N/A N/A No Yes Yes No No No Yes N/A Yes No No Yes No Yes No Yes No Yes No N/A Yes No No No No No N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach undertakings for

the clause no. 4, 8,9, 13, 14, 16 & 18 of the

firm wise knockdown criteria of

prequalification document.

3. The firm did not attach undertakings for

the clause no. 3, 6, 7,8,9 & 10 of the product

wise knockdown criteria of prequalification

document.

176Sind Medical

Stores10

Black Silk, Size

2/0,60mm straight

cutting needle

12

DemeTEC

H

Corporati

on USA

DemeSILK Size 2/0, 60mm StraightUnited

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

177Sind Medical

Stores11

Black Silk, Size 1, 30mm,

1/2Circle round body

needle

12

DemeTEC

H

Corporati

on USA

DemeSILK Size 1,30mmUnited

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 20 of 29

Page 21: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

178Sind Medical

Stores18

Catgut Chromic, Size 1,

with 40mm Intestinal RB

Needle

12

DemeTEC

H

Corporati

on USA

DemeGUT Size 1,40mmUnited

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

179Sind Medical

Stores19

Catgut Chromic, Size

1,30mm, ½ Circle RB

Needle

12

DemeTEC

H

Corporati

on USA

DemeGUT Size 1, 30mmUnited

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

180Sind Medical

Stores21

Catgut Chromic, Size2/0

,30mm, 1/2 Circle Round

Body needle

12

DemeTEC

H

Corporati

on USA

DemeGUT Size 2/0,30mmUnited

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

181Sind Medical

Stores27

Disposable Insulin

Syringe 1ml with needle

(Blister Pack)

100

Wuxi

Yushou

Medical

Applianc

es Co.,

Ltd.

Yushou 1ml (30G x 5/16) China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

182Sind Medical

Stores28

Disposable syringe 10ml

with needle. (Blister

pack)

100

Wuxi

Yushou

Medical

Applianc

es Co.,

Ltd.

Yushou 10ml (22G x 1 1/4) China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

183Sind Medical

Stores29

Disposable Syringe 20ml

with needle. (Blister

pack)

100

Wuxi

Yushou

Medical

Applianc

es Co.,

Ltd.

Yushou 20ml (21G x 1 1/2) China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

184Sind Medical

Stores30

Disposable Syringe 50ml

with needle. (Blister

pack)

50

Wuxi

Yushou

Medical

Applianc

es Co.,

Ltd.

Yushou 50ml (21G x 1 1/2) China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

185Sind Medical

Stores49

Poly propylene Size 1,

40mm 1/2 circle RB

Needle

12

DemeTEC

H

Corporati

on USA

DemeLENE Size 1,40mmUnited

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

186Sind Medical

Stores50

Poly propylene, Size 2/0,

30mm 1/2 circle RB

Needle

12

DemeTEC

H

Corporati

on USA

DemeLENE Size 2/0 , 30mmUnited

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

187Sind Medical

Stores51

Poly propylene, Size

2/0,60mm Straight

Cutting needle (SCN)

12

DemeTEC

H

Corporati

on USA

DemeLENE Size 2/0, 60mmUnited

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

188Sind Medical

Stores52

Polyglactin/ Polyglycolic

acid, Size 1,40mm.1/2

Circle Round Body

needle

12

DemeTEC

H

Corporati

on USA

DemeSORB Size 1,40mmUnited

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

189Sind Medical

Stores53

Polyglactin/ Polyglycolic

acid, size 2/0,30mm, 1/2

Circle Round Body

needle

12

DemeTEC

H

Corporati

on USA

DemeSORB Size 2/0,30mmUnited

StatesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

190Sind Medical

Stores63

Urine Bags Sterile

(2000ml) Packs 250

NINGBO

GREATCA

RE

MEDICAL

INSTRUM

ENTS

CO.,LTD

Great Uro 2000ml China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach valid Device

Enlistment certificate of the quoted item.

2. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

191 SY'AH IMPEX 27Disposable Insulin

Syringe 1ml with needle

(Blister Pack)

100

CHANGZ

HOU

TONGDA

MEDICAL

APPLIAN

CE CO

LTD

SHIFA SINGLE PACK China Yes Yes Yes Yes Yes N/A Yes No Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No No Yes No No Yes No No Yes YesNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not attach undertaking for

the clause no. 8 of the firm wise knockdown

criteria of prequalification document.

3. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

4. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of prequalification

document.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

Page 21 of 29

Page 22: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

192 SY'AH IMPEX 28Disposable syringe 10ml

with needle. (Blister

pack)

100

CHANGZ

HOU

TONGDA

MEDICAL

APPLIAN

CE CO

LTD

SHIFA SINGLE PACK China Yes Yes Yes Yes Yes N/A Yes No Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No No Yes Yes No Yes No No Yes YesNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not attach undertaking for

the clause no. 8 of the firm wise knockdown

criteria of prequalification document.

3. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

4. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of prequalification

document.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

193 SY'AH IMPEX 29Disposable Syringe 20ml

with needle. (Blister

pack)

50

CHANGZ

HOU

TONGDA

MEDICAL

APPLIAN

CE CO

LTD

SHIFA SINGLE PACK China Yes Yes Yes Yes Yes N/A Yes No Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No No Yes Yes No Yes No No Yes YesNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not attach undertaking for

the clause no. 8 of the firm wise knockdown

criteria of prequalification document.

3. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

4. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of prequalification

document.

194 SY'AH IMPEX 30Disposable Syringe 50ml

with needle. (Blister

pack)

25

CHANGZ

HOU

TONGDA

MEDICAL

APPLIAN

CE CO

LTD

SHIFA SINGLE PACK China Yes Yes Yes Yes Yes N/A Yes No Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No No Yes No No Yes No No Yes YesNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not attach undertaking for

the clause no. 8 of the firm wise knockdown

criteria of prequalification document.

3. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

4. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of prequalification

document.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

195 SY'AH IMPEX 31

Disposable Syringe 60ml

with Central Nozzle or

Catheter Tip (Blister

Pack)

50

CHANGZ

HOU

TONGDA

MEDICAL

APPLIAN

CE CO

LTD

SHIFA SINGLE PACK China Yes Yes Yes Yes Yes N/A Yes No Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No No Yes Yes No Yes No No Yes NoNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not attach undertaking for

the clause no. 8 of the firm wise knockdown

criteria of prequalification document.

3. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

4. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of prequalification

document.

5. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

196 SY'AH IMPEX 39

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 18G

50

JIANGXI

SANXIN

MEDTEC

CO LTD

SHIFA SINGLE PACK China Yes Yes Yes Yes Yes N/A No No Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes No No Yes No No Yes No No Yes NoNot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach undertaking for

the clause no. 8 of the firm wise knockdown

criteria of prequalification document.

5. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

6. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of prequalification

document.

7. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

8. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 22 of 29

Page 23: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

197 SY'AH IMPEX 40

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 20G

50

JIANGXI

SANXIN

MEDTEC

CO LTD

SHIFA SINGLE PACK Chile Yes Yes Yes Yes Yes N/A No No Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes No No Yes No No Yes No No Yes NoNot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach undertaking for

the clause no. 8 of the firm wise knockdown

criteria of prequalification document.

5. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

6. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of prequalification

document.

7. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

8. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

198 SY'AH IMPEX 41

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 22G

50

JIANGXI

SANXIN

MEDTEC

CO LTD

SHIFA SINGLE PACK China Yes Yes Yes Yes Yes N/A No No Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes No No Yes No No Yes No No Yes NoNot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach undertaking for

the clause no. 8 of the firm wise knockdown

criteria of prequalification document.

5. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

6. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of prequalification

document.

7. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

8. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

199 SY'AH IMPEX 42

I.V Cannula

with/without Injection

Port with Integrated

Closing Cone Sterile Pack

24G

50

JIANGXI

SANXIN

MEDTEC

CO LTD

SHIFA SINGLE PACK China Yes Yes Yes Yes Yes N/A No No Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes No No Yes No No Yes No No Yes NoNot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach undertaking for

the clause no. 8 of the firm wise knockdown

criteria of prequalification document.

5. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

6. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of prequalification

document.

7. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

8. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 23 of 29

Page 24: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

200 SY'AH IMPEX 43I.V. Sets Sterile blister

Pack 500

CHANGZ

HOU

TONGDA

MEDICAL

APPLIAN

CE CO

LTD

SHIFA SINGLE PACK China Yes Yes Yes Yes Yes N/A Yes No Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No No Yes No No Yes No No Yes NoNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not attach undertaking for

the clause no. 8 of the firm wise knockdown

criteria of prequalification document.

3. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

4. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of prequalification

document.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

201 SY'AH IMPEX 56Sterile Surgical Gloves

Pairs 6 ½, 7, 7 ½

(Powdered)

50

Shanghai

Motex

Healthcar

e Co.,

Ltd.

SHIFA PAIR China Yes Yes Yes Yes Yes N/A Yes No Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes No Yes No No Yes No No Yes NoNot-

Prequalified

1. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not attach undertaking for

the clause no. 8 of the firm wise knockdown

criteria of prequalification document.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of prequalification

document.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

202 SY'AH IMPEX 63Urine Bags Sterile

(2000ml) Packs 250

CHANGZ

HOU

YUEKAN

G

MEDICAL

APPLIAN

CE CO

LTD

EXPORTE

D BY

CHANGZ

HOU

LIANJIE

IMP. &

EXP CO

SHIFA SINGLE USE Chad Yes Yes Yes Yes No N/A Yes No Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes No No Yes No No Yes No No Yes NoNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

2. The firm did not attach undertaking for

the clause no. 8 of the firm wise knockdown

criteria of prequalification document.

3. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

4. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of prequalification

document.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

203The Searle

Company34

Examination Gloves

Latex (S.M.L) 100

TG

Medical

Sdn Bhd

Selangor

Malaysia

Protiex S,M.L Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A No Yes Yes Yes Yes Yes No Yes Yes No Yes No Yes Yes NoNot-

Prequalified

1. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

2. The firm did not attach undertakings for

the clause no. 3, 6, & 8 of the product wise

knockdown criteria of prequalification

document.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

204The Searle

Company39

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 18G

Abu

Dhabi

Medical

Devices

Co. LLC

Medeco 18 GUnited Arab

EmiratesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A No N/A No Yes Yes Yes Yes Yes No Yes No No Yes No Yes Yes No

Not-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

3. The firm did not attach undertakings for

the clause no. 3, 6, & 8 of the product wise

knockdown criteria of prequalification

document.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 24 of 29

Page 25: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

205The Searle

Company40

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 20G

Abu

Dhabi

Medical

Devices

Co. LLC

Medeco 20United Arab

EmiratesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A No N/A No Yes Yes Yes Yes Yes No Yes No No Yes No Yes Yes No

Not-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

3. The firm did not attach undertakings for

the clause no. 3, 6, & 8 of the product wise

knockdown criteria of prequalification

document.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

206The Searle

Company41

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 22G

Abu

Dhabi

Medical

Devices

Co. LLC

Medeco 22 GUnited Arab

EmiratesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A No N/A No Yes Yes Yes Yes Yes No Yes No No Yes No Yes Yes Yes

Not-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

3. The firm did not attach undertakings for

the clause no. 3, 6, & 8 of the product wise

knockdown criteria of prequalification

document.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

207The Searle

Company42

I.V Cannula

with/without Injection

Port with Integrated

Closing Cone Sterile Pack

24G

Abu

Dhabi

Medical

Devices

Co. LLC

MedecoUnited Arab

EmiratesYes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A No N/A No Yes Yes Yes Yes Yes No Yes No No Yes No Yes Yes No

Not-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

3. The firm did not attach undertakings for

the clause no. 3, 6, & 8 of the product wise

knockdown criteria of prequalification

document.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

208The Searle

Company56

Sterile Surgical Gloves

Pairs 6 ½, 7, 7 ½

(Powdered)

TG

Medical

Sdn Bhd

Selangor

Malaysia

Protiex Size 6.5, 7.0, 7.5 Malaysia Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A No Yes Yes Yes Yes Yes No Yes Yes No Yes No Yes Yes NoNot-

Prequalified

1. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

2. The firm did not attach undertakings for

the clause no. 3, 6, & 8 of the product wise

knockdown criteria of prequalification

document.

3. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

209Total

Technologies

(Pvt.) Limited

44Instrumental

Disinfectant Solution Of

appropriate composition

1

Borer

Chemie

Switzerla

nd

Borer Chemie

AGLiter Switzerland Yes Yes No Yes Yes N/A Yes Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes No No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach valid sole agency

certificate for the quoted item.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 25 of 29

Page 26: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

210Total

Technologies

(Pvt.) Limited

60Surface Disinfectant

Solution Of appropriate

composition

1

Borer

Chemie

Switzerla

nd

Borer Chemie

AGLiter Switzerland Yes Yes No Yes Yes N/A Yes Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes No No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach valid sole agency

certificate for the quoted item.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

211UNISA (PVT)

Limited 28

Disposable syringe 10ml

with needle. (Blister

pack)

100

Unisa

Private

Limited

Main G.T.

Road,

Adamzai,

Akora

Khattak,

District

Nowsher

a K.P.K

Pakistan.

UNIJECT 10ml Pakistan Yes N/A N/A Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes No Yes Yes N/A Yes Yes Yes No Yes Yes N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach undertaking for

the clause no. 8of the product wise

knockdown criteria of prequalification

document.

212UNISA (PVT)

Limited 43

I.V. Sets Sterile blister

Pack 20

Unisa

Private

Limited

Main G.T.

Road,

Adamzai,

Akora

Khattak,

District

Nowsher

a K.P.K

Pakistan.

UNISET Blister pack Pakistan Yes N/A N/A Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes No Yes Yes N/A Yes Yes No No Yes No N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The firm did not attach undertaking for

the clause no. 8of the product wise

knockdown criteria of prequalification

document.

3.Declared substandard by DTL Lahore Vide

TRA No.01-143002186.

4.The firm is prosecuted by PQCB in 231-M

on the offence of substandard.

213Usmanco

International28

Disposable syringe 10ml

with needle. (Blister

pack)

100

JiangXi

Sanxin

Medtec

Co., Ltd.

UCI Disposable

Syringe

10ml Syringe with Needle

22G x 1¼''China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

3. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

214Usmanco

International29

Disposable Syringe 20ml

with needle. (Blister

pack)

50

JiangXi

Sanxin

Medtec

Co., Ltd.

UCI Disposable

Syringe

20ml Syringe with Needle

21G x 1½'Turkey Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

215Usmanco

International30

Disposable Syringe 50ml

with needle. (Blister

pack)

20

JiangXi

Sanxin

Medtec

Co., Ltd.

UCI Disposable

Syringe

50ml Syringe with Needle

21G x 1½''China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

2. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

3. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

4. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

216Usmanco

International32

Endotracheal tube (all

sizes) Sterile Packs with

cuff Set

10

Chilecom

Medical

Devices

Co., Ltd

Endosoft

Endotracheal

Tubes With Cuff

2.5,3.0,3.5,4.0,4.5,5.0,5.5,6.

0,6.5,7.0,7.5,8.0 & 8.5China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 26 of 29

Page 27: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

217Usmanco

International33

Endotracheal tube (all

sizes) Sterile Packs

without cuff Set

10

Chilecom

Medical

Devices

Co., Ltd

Endosoft

Endotracheal

Tubes Without

Cuff

2.5,3.0,3.5,4.0,4.5,5.0 & 5.5 China Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

218Usmanco

International39

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 18G

50

BIÇAKCIL

AR TIBBI

CIHAZLAR

SANAYI

ve

TICARET

A.S.

B-Cat 2 I.V.

Cannula18 G Turkey Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

219Usmanco

International40

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 20G

50

BIÇAKCIL

AR TIBBI

CIHAZLAR

SANAYI

ve

TICARET

A.S.

B-Cat 2 I.V.

Cannula20 G Turkey Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

220Usmanco

International41

I.V Cannula with

Injection Port and

Integrated Closing Cone

Sterile Pack 22G

50

BIÇAKCIL

AR TIBBI

CIHAZLAR

SANAYI

ve

TICARET

A.S.

B-Cat 2 I.V.

Cannula22 G Turkey Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

221Usmanco

International42

I.V Cannula

with/without Injection

Port with Integrated

Closing Cone Sterile Pack

24G

50

BIÇAKCIL

AR TIBBI

CIHAZLAR

SANAYI

ve

TICARET

A.S.

B-Cat 2 I.V.

Cannula24 G Turkey Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

222Usmanco

International47

Nasogastric tube (all

sizes) Sterile Packs 150

BIÇAKCIL

AR TIBBI

CIHAZLAR

SANAYI

ve

TICARET

A.S.

Nasogastric

Catheter

12Ch,14Ch,16Ch,18Ch &

20Ch x 121cm LengthTurkey Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

223Usmanco

International48

Nelton Catheter Sterile

Packs 100

BIÇAKCIL

AR TIBBI

CIHAZLAR

SANAYI

ve

TICARET

A.S.

Nelaton

Catheter

06Ch,08Ch, 10Ch, 12Ch,

14Ch, 16Ch,

18Ch,20Ch,22Ch & 24Ch x

40cm Length

Turkey Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

224Usmanco

International59

Suction Catheter (All

Sizes) 100

BIÇAKCIL

AR TIBBI

CIHAZLAR

SANAYI

ve

TICARET

A.S.

Suction

Catheter

06Ch, 08Ch, 10Ch, 12Ch,

14Ch, 16Ch & 18Ch x 50cm

Length

Turkey Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

225Usmanco

International61

Three-way stopper with

Tubing  150

BIÇAKCIL

AR TIBBI

CIHAZLAR

SANAYI

ve

TICARET

A.S.

3-Way Stopcock 10cm Tubing Turkey Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

226Usmanco

International62

Three-way stopper

without Tubing  150

BIÇAKCIL

AR TIBBI

CIHAZLAR

SANAYI

ve

TICARET

A.S.

3-Way Stopcock Plain Turkey Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A No N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach undertaking for

the clause no.14 of the firm wise

knockdown criteria of prequalification

document i.e., "none of its supplied batch in

public sector institutions has been declared

Spurious/Adulterated since January 2018

onwards."

2. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

227VIKOR

Healthcare Pvt

Limited Karachi

10Black Silk, Size

2/0,60mm straight

cutting needle

12Vikor

Healthcar

e

Surgiline Silk

Braided (SS004)2/0M3 Pakistan Yes N/A N/A Yes Yes Yes No Yes Yes No Yes Yes Yes No Yes No Yes Yes Yes No Yes Yes N/A No Yes Yes Yes Yes Yes N/A

Not-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

3. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

Page 27 of 29

Page 28: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

228VIKOR

Healthcare Pvt

Limited Karachi

11Black Silk, Size 1, 30mm,

1/2Circle round body

needle

12Vikor

Healthcar

e

Surgiline Silk

Braided

(STH202)

1M4 Pakistan Yes N/A N/A Yes Yes Yes No Yes Yes No Yes Yes Yes No Yes No Yes Yes Yes No Yes Yes N/A No Yes Yes Yes Yes Yes N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

3. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

229VIKOR

Healthcare Pvt

Limited Karachi

13Black Silk,2/0,30mm 1/2

circle round body

needle

12Vikor

Healthcar

e

Surgilene Silk

Braided (ST204)2/0M3 Pakistan Yes N/A N/A Yes Yes Yes No Yes Yes No Yes Yes Yes No Yes No Yes Yes Yes No Yes Yes N/A No Yes Yes Yes Yes Yes N/A

Not-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

3. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

230VIKOR

Healthcare Pvt

Limited Karachi

18Catgut Chromic, Size 1,

with 40mm Intestinal RB

Needle

12Vikor

Healthcar

e

Surgilene

Surgigut

Chromic (CT205)

1M5 Pakistan Yes N/A N/A Yes Yes Yes No Yes Yes No Yes Yes Yes No Yes No Yes Yes Yes No Yes Yes N/A Yes Yes Yes Yes Yes Yes N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

3. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

231VIKOR

Healthcare Pvt

Limited Karachi

19Catgut Chromic, Size

1,30mm, ½ Circle RB

Needle

12Vikor

Healthcar

e

Surgiline

Surgigut

Chromic (CT207)

1M5 Pakistan Yes N/A N/A Yes Yes Yes No Yes Yes No Yes Yes Yes No Yes No Yes Yes Yes No Yes Yes N/A Yes Yes Yes Yes Yes Yes N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

3. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

232VIKOR

Healthcare Pvt

Limited Karachi

21Catgut Chromic, Size2/0

,30mm, 1/2 Circle Round

Body needle

12Vikor

Healthcar

e

Surgiline

Surgigut

Chromic (CT220)

2/0M3.5 Pakistan Yes N/A N/A Yes Yes Yes No Yes Yes No Yes Yes Yes No Yes No Yes Yes Yes No Yes Yes N/A Yes Yes Yes Yes Yes Yes N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

3. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

233VIKOR

Healthcare Pvt

Limited Karachi

49Poly propylene Size 1,

40mm 1/2 circle RB

Needle

12Vikor

Healthcar

e

Surgiline

Surgilene

(NT202)

1M4 Pakistan Yes N/A N/A Yes Yes Yes No Yes Yes No Yes Yes Yes No Yes No Yes Yes Yes No Yes Yes N/A No Yes Yes Yes Yes Yes N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2.

3. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

Page 28 of 29

Page 29: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of Medical Devices for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By Quoted Brand Strength

Country of

Origin

Valid

License to

Manufactur

e/Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking

of valid sole

agency

agreement

Undertaking of

not blacklisted/

debarred by any

procuring

agency.

Firm will

provide

valid ISO

13485.

Valid

GMP (For

local

manufact

urer)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Undertaking of Proper

warehouseproper

warehouse and storage

facility as per

recommendation of the

manufacturer and at

required temperature and

follows good storage and

distribution practice. Firm

will provide undertaking

on legally notarized stamp

paper of rupees 100.

Procuring Agency may

physically verify firm’s

claim. Firm must mention

address of its storage

facility on undertaking.

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufacture

r only)

Undertaking

following labor

laws (For

manufacturer

only)

Undertaking of

its supplied

batch in Public

Sector

Institutions has

been declared

Spurious/Adulte

rated

Form-29 issued

by SECP. (Article

of association of

companies)

/Form C

(Registered from

registrar of

firms)/ sole

proprietorship.

(For

manufacturer

only)

Undertaking of

Non prosecuted

by PQCB on the

offense of

Spurious/Adulte

rated Medical

Device.

Original

Receipt

Undertaki

ng of

acceptanc

e of T&C

of PQD

Apply on

online

portal

(PQOD)

Valid

CE/UNFP

A/JMHLW

/US FDA

approval

certificati

on or

prequalifi

cation by

WHO

Device

Enlistment

Certificate

Undertaking for

Required

storage

temperature as

per product's

requirement

Valid Sole

Agency

Agreemen

t of

quoted

item

foratleast

one year

(for

importers)

Public

Sector

Purchase

Orders

(Last

Three

Years)

Undertaking

for

Spurious/Ad

ulterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP since

01-01-2020

Undertaking

for any

punitive

action taken

by PQCB since

01-01-2020

GDs certificates

for quoted item

for atleast last

three

consective

years

Status Remarks

234VIKOR

Healthcare Pvt

Limited Karachi

50Poly propylene, Size 2/0,

30mm 1/2 circle RB

Needle

12Vikor

Healthcar

e

Surgiline

Surgilene

(NT205)

2/0M3 Pakistan Yes N/A N/A Yes Yes Yes No Yes Yes No Yes Yes Yes No Yes No Yes Yes Yes No Yes Yes N/A No Yes Yes Yes Yes Yes N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

3. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

235VIKOR

Healthcare Pvt

Limited Karachi

51Poly propylene, Size

2/0,60mm Straight

Cutting needle (SCN)

12Vikor

Healthcar

e

Surgiline

Surgilene

(NS002)

2/0M3 Pakistan Yes N/A N/A Yes Yes Yes No Yes Yes No Yes Yes Yes No Yes No Yes Yes Yes No Yes Yes N/A No Yes Yes Yes Yes Yes N/ANot-

Prequalified

1. The firm did not attach Valid

CE/UNFPA/JMHLW/US FDA approval

certification or prequalification by WHO for

the quoted item.

2. The Annual financial turnover of the firm

is less than the required Minimum Annual

financial turnover i.e., 330 Million as per

clause no. 10 of the firm wise knockdown

criteria of the prequalification document.

3. The firm did not attach undertaking for

the clause no. 14 & 16 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

236 ZEDCO 14Blood Bags Sterile Packs

250ml single 100

Terumo

BCT, Ltd.

old

belfast

Road,

millbrook

, larne.

BT 40,

2SH,

United

Kingdom

Teruflex SingleUnited

KingdomYes Yes Yes Yes Yes N/A Yes No Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach undertaking for

the clause no.8 of the firm wise knockdown

criteria of prequalification document.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

5. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

237 ZEDCO 15Blood Bags Sterile Packs

500ml single 100

Terumo

BCT, Ltd.

old

belfast

Road,

millbrook

, larne.

BT 40,

2SH,

United

Kingdom

Teruflex SingleUnited

KingdomYes Yes Yes Yes Yes N/A Yes No Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No

Not-

Prequalified

1. The firm did not attach undertaking for

the clause no.8 of the firm wise knockdown

criteria of prequalification document.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

238 ZEDCO 16Blood Transfusion Set

Sterile Packs 50

Terumo

BCT, Ltd.

old

belfast

Road,

millbrook

, larne.

BT 40,

2SH,

United

Kingdom

Terufusion Single Japan Yes Yes Yes Yes Yes N/A Yes No Yes No No N/A N/A Yes N/A Yes Yes Yes Yes Yes No Yes Yes No Yes Yes Yes Yes Yes NoNot-

Prequalified

1. The firm did not attach undertaking for

the clause no.8 of the firm wise knockdown

criteria of prequalification document.

2. The firm did not attach FBR sales/income

tax returns of last three financial/calendar

years.

3. The firm did not submit valid registration

of manufacturing firm with chamber of

commerce from country of manufacturer.

4. The firm did not attach valid DRC/Device

Enlistment certificate of the quoted item.

5. The firm did not attach Purchase orders

of quoted item for the last three

consecutive years.

6. The firm did not attach GD certificates of

quoted item for the last three consecutive

years.

Page 29 of 29

Page 30: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of AD/RUP Syringes for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By

Quoted

BrandStrength

Country of

Origin

Valid License

to

Manufacture/

Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking of

valid sole

agency

agreement

Undertaking of

not

blacklisted/

debarred by

any procuring

agency.

Firm will

provide

valid ISO

13485.

Valid GMP

(For local

manufactu

rer)

Valid

CE/UNFPA

/JMHLW/

US FDA

approval

certificati

on or

prequalific

ation by

WHO

Undertaking of

Proper

warehouseproper

warehouse and

storage facility as

per

recommendation

of the

manufacturer and

at required

temperature and

follows good

storage and

distribution

practice. Firm will

provide

undertaking on

legally notarized

stamp paper of

rupees 100.

Procuring Agency

may physically

verify firm’s

claim. Firm must

mention address

of its storage

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufactu

rer only)

Undertaking

following

labor laws

(For

manufacture

r only)

Undertaking

of its supplied

batch in

Public Sector

Institutions

has been

declared

Spurious/Adul

terated

Form-29

issued by

SECP.

(Article of

association

of

companies)

/Form C

(Registered

from

registrar of

firms)/ sole

proprietors

hip. (For

manufactur

er only)

Undertaking

of Non

prosecuted

by PQCB on

the offense

of

Spurious/Ad

ulterated

Medical

Device.

Original

Receipt

Undertaking

of acceptance

of T&C of

PQD

Apply on

online

portal

(PQOD)

Valid US FDA

approval

certification

or

prequalificati

on by WHO

Device

Enlistment

Certificate

Undertaking

for Required

storage

temperature

as per

product's

requirement

Valid Sole

Agency

Agreement of

quoted item

foratleast

one year (for

importers)

Undertaking

for

Spurious/Adu

lterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP

since 01-01-

2020

Undertaking

for any

punitive

action taken

by PQCB

since 01-01-

2020

Status Remarks

1Amson Vaccines

and Pharma

(Private) Ltd

2

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 2ml with

needle (Blister

Pack)

100

Amson

Vaccines

and Pharma

(Pvt) Ltd

Apple K1

2ml Auto

Disable

Syringe

2 Pakistan Yes N/A N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes Prequalified

2

Amson Vaccines

and Pharma

(Private) Ltd

4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

100

Amson

Vaccines

and Pharma

(Pvt) Ltd

Apple K1

5ml Auto

Disable

Syringe

5 Pakistan Yes N/A N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes Prequalified

3Amson Vaccines

and Pharma

(Private) Ltd

5

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 0.5ml

with needle

(Blister Pack)

100

Amson

Vaccines

and Pharma

(Pvt) Ltd

Apple K1

0.5ml Auto

Disable

syringe

0.5 Pakistan Yes N/A N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes Prequalified

4ASTO Life

Sciences Private

Limited

2

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 2ml with

needle (Blister

Pack)

100

Becton

Dickinson

S.A

BD 2CC Spain Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

5

ASTO Life

Sciences Private

Limited

4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

100

Becton

Dickinson

S.A

BD 5CC Spain Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

6Hashir Surgical

Services 1

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 10 ml

with needle

(Blister Pack)

100

Revital

Healthcare

(EPZ)

Limited

REVITAL 10CC Kenya Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

7Hashir Surgical

Services 2

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 2ml with

needle (Blister

Pack)

100

Revital

Healthcare

(EPZ)

Limited

REVITAL 2CC Kenya Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

8Hashir Surgical

Services 4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

100

Revital

Healthcare

(EPZ)

Limited

REVITAL 5CC Kenya Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

9Hashir Surgical

Services 5

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 0.5ml

with needle

(Blister Pack)

100

Revital

Healthcare

(EPZ)

Limited

REVITAL

CADY0.5CC Kenya Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Prequalified

10Hospital Services

& Sales1

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 10 ml

with needle

(Blister Pack)

100

Wuxi

Yushou

Medical

Appliances

Co., Ltd.,

China

Yushou10ml (22G X

1/1/4)China Yes Yes Yes Yes Yes N/A No Yes Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

11Hospital Services

& Sales3

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 3ml with

needle (Blister

Pack)

100

Wuxi

Yushou

Medical

Appliances

Co., Ltd.,

China

Yushou3ml (24G x

1)China Yes Yes Yes Yes Yes NULL Yes Yes Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

12Hospital Services

& Sales4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

100

Wuxi

Yushou

Medical

Appliances

Co., Ltd.,

China

Yushou5ml ( 23G x

1)China Yes Yes Yes Yes Yes NULL Yes Yes Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

Page 1 of 7

Page 31: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of AD/RUP Syringes for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By

Quoted

BrandStrength

Country of

Origin

Valid License

to

Manufacture/

Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking of

valid sole

agency

agreement

Undertaking of

not

blacklisted/

debarred by

any procuring

agency.

Firm will

provide

valid ISO

13485.

Valid GMP

(For local

manufactu

rer)

Valid

CE/UNFPA

/JMHLW/

US FDA

approval

certificati

on or

prequalific

ation by

WHO

Undertaking of

Proper

warehouseproper

warehouse and

storage facility as

per

recommendation

of the

manufacturer and

at required

temperature and

follows good

storage and

distribution

practice. Firm will

provide

undertaking on

legally notarized

stamp paper of

rupees 100.

Procuring Agency

may physically

verify firm’s

claim. Firm must

mention address

of its storage

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufactu

rer only)

Undertaking

following

labor laws

(For

manufacture

r only)

Undertaking

of its supplied

batch in

Public Sector

Institutions

has been

declared

Spurious/Adul

terated

Form-29

issued by

SECP.

(Article of

association

of

companies)

/Form C

(Registered

from

registrar of

firms)/ sole

proprietors

hip. (For

manufactur

er only)

Undertaking

of Non

prosecuted

by PQCB on

the offense

of

Spurious/Ad

ulterated

Medical

Device.

Original

Receipt

Undertaking

of acceptance

of T&C of

PQD

Apply on

online

portal

(PQOD)

Valid US FDA

approval

certification

or

prequalificati

on by WHO

Device

Enlistment

Certificate

Undertaking

for Required

storage

temperature

as per

product's

requirement

Valid Sole

Agency

Agreement of

quoted item

foratleast

one year (for

importers)

Undertaking

for

Spurious/Adu

lterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP

since 01-01-

2020

Undertaking

for any

punitive

action taken

by PQCB

since 01-01-

2020

Status Remarks

13Hospital Services

& Sales5

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 0.5ml

with needle

(Blister Pack)

200

Wuxi

Yushou

Medical

Appliances

Co., Ltd.,

China

Yushou0.5ml (24G x

3/4)China Yes Yes Yes Yes Yes NULL Yes Yes Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

14Hospital Services

& Sales6

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 1ml with

needle (Blister

Pack)

100

Wuxi

Yushou

Medical

Appliances

Co., Ltd.,

China

Yushou1ml (24G x

1)China Yes Yes Yes Yes Yes NULL Yes Yes Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

15 KM ENTERPRISES 3

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 3ml with

needle (Blister

Pack)

100

Changzhou

Medical

Appliances

General

Factory

Co,Ltd

China

AMD 3ml China Yes Yes Yes Yes No N/A No Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes No No Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not submit valid ISO

13485.Submitted certificate is

forged/edited/fake.The scope mentioned

on online website of issuaing organization

(TUV Rheinland) is different from

certificate submitted in the bid.Auto

Disable syringes is mentioned in submitted

certificate while online certificate does not

contain auto disable syringes in its scope.

2. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

3. The firm did not attach valid Device

Enlistment certificate of the quoted item.

16 KM ENTERPRISES 4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

100

Changzhou

Medical

Appliances

General

Factory

Co,Ltd

China

AMD 5ml China Yes Yes Yes Yes No N/A No Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes No No Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not submit valid ISO

13485.Submitted certificate is

forged/edited/fake.The scope mentioned

on online website of issuaing organization

(TUV Rheinland) is different from

certificate submitted in the bid.Auto

Disable syringes is mentioned in submitted

certificate while online certificate does not

contain auto disable syringes in its scope.

2. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

3. The firm did not attach valid Device

Enlistment certificate of the quoted item.

17 KM ENTERPRISES 6

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 1ml with

needle (Blister

Pack)

100

Changzhou

Medical

Appliances

General

Factory

Co,Ltd

China

AMD 1ml China Yes Yes Yes Yes No N/A No Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes No No Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not submit valid ISO

13485.Submitted certificate is

forged/edited/fake.The scope mentioned

on online website of issuaing organization

(TUV Rheinland) is different from

certificate submitted in the bid.Auto

Disable syringes is mentioned in submitted

certificate while online certificate does not

contain auto disable syringes in its scope.

2. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

3. The firm did not attach valid Device

Enlistment certificate of the quoted item.

Page 2 of 7

Page 32: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of AD/RUP Syringes for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By

Quoted

BrandStrength

Country of

Origin

Valid License

to

Manufacture/

Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking of

valid sole

agency

agreement

Undertaking of

not

blacklisted/

debarred by

any procuring

agency.

Firm will

provide

valid ISO

13485.

Valid GMP

(For local

manufactu

rer)

Valid

CE/UNFPA

/JMHLW/

US FDA

approval

certificati

on or

prequalific

ation by

WHO

Undertaking of

Proper

warehouseproper

warehouse and

storage facility as

per

recommendation

of the

manufacturer and

at required

temperature and

follows good

storage and

distribution

practice. Firm will

provide

undertaking on

legally notarized

stamp paper of

rupees 100.

Procuring Agency

may physically

verify firm’s

claim. Firm must

mention address

of its storage

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufactu

rer only)

Undertaking

following

labor laws

(For

manufacture

r only)

Undertaking

of its supplied

batch in

Public Sector

Institutions

has been

declared

Spurious/Adul

terated

Form-29

issued by

SECP.

(Article of

association

of

companies)

/Form C

(Registered

from

registrar of

firms)/ sole

proprietors

hip. (For

manufactur

er only)

Undertaking

of Non

prosecuted

by PQCB on

the offense

of

Spurious/Ad

ulterated

Medical

Device.

Original

Receipt

Undertaking

of acceptance

of T&C of

PQD

Apply on

online

portal

(PQOD)

Valid US FDA

approval

certification

or

prequalificati

on by WHO

Device

Enlistment

Certificate

Undertaking

for Required

storage

temperature

as per

product's

requirement

Valid Sole

Agency

Agreement of

quoted item

foratleast

one year (for

importers)

Undertaking

for

Spurious/Adu

lterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP

since 01-01-

2020

Undertaking

for any

punitive

action taken

by PQCB

since 01-01-

2020

Status Remarks

18 Meher Traders 1

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 10 ml

with needle

(Blister Pack)

1

Hunan

Luzhou

Huikang

Developme

nt Co.,Ltd.

China

WELLMED 10 China Yes Yes Yes Yes No N/A No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No Yes Yes YesNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

3. The firm did not attach FBR

sales/income tax returns of last three

financial/calendar years.

4. The firm did not submit valid

registration of manufacturing firm with

chamber of commerce from country of

manufacturer.

5. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

19 Meher Traders 3

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 3ml with

needle (Blister

Pack)

1

Hunan

Luzhou

Huikang

Developme

nt Co.,Ltd.

China

WELLMED 3 China Yes Yes Yes Yes No N/A No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No Yes Yes YesNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

3. The firm did not attach FBR

sales/income tax returns of last three

financial/calendar years.

4. The firm did not submit valid

registration of manufacturing firm with

chamber of commerce from country of

manufacturer.

5. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

20 Meher Traders 4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

1

Hunan

Luzhou

Huikang

Developme

nt Co.,Ltd.

China

WELLMED 5 China Yes Yes Yes Yes No N/A No Yes Yes No No N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes No No Yes Yes YesNot-

Prequalified

1. The firm did not submit valid ISO 13485.

2. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

3. The firm did not attach FBR

sales/income tax returns of last three

financial/calendar years.

4. The firm did not submit valid

registration of manufacturing firm with

chamber of commerce from country of

manufacturer.

5. The firm did not attach undertakings for

the clause no.6 & 7 of the product wise

knockdown criteria of prequalification

document.

21Nipro Medical Pvt

Ltd1

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 10 ml

with needle

(Blister Pack)

100

JMI

Syringes &

Medical

Devices Ltd.

JMI AD

Syringe10cc Bangladesh Yes Yes Yes Yes Yes N/A No Yes Yes No No N/A N/A No N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

2. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

3. The firm did not submit valid

registration of manufacturing firm with

chamber of commerce from country of

manufacturer.

4. The firm did not attach undertaking for

the clause no. 14 of the firm wise

knockdown criteria of prequalification

document.

Page 3 of 7

Page 33: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of AD/RUP Syringes for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By

Quoted

BrandStrength

Country of

Origin

Valid License

to

Manufacture/

Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking of

valid sole

agency

agreement

Undertaking of

not

blacklisted/

debarred by

any procuring

agency.

Firm will

provide

valid ISO

13485.

Valid GMP

(For local

manufactu

rer)

Valid

CE/UNFPA

/JMHLW/

US FDA

approval

certificati

on or

prequalific

ation by

WHO

Undertaking of

Proper

warehouseproper

warehouse and

storage facility as

per

recommendation

of the

manufacturer and

at required

temperature and

follows good

storage and

distribution

practice. Firm will

provide

undertaking on

legally notarized

stamp paper of

rupees 100.

Procuring Agency

may physically

verify firm’s

claim. Firm must

mention address

of its storage

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufactu

rer only)

Undertaking

following

labor laws

(For

manufacture

r only)

Undertaking

of its supplied

batch in

Public Sector

Institutions

has been

declared

Spurious/Adul

terated

Form-29

issued by

SECP.

(Article of

association

of

companies)

/Form C

(Registered

from

registrar of

firms)/ sole

proprietors

hip. (For

manufactur

er only)

Undertaking

of Non

prosecuted

by PQCB on

the offense

of

Spurious/Ad

ulterated

Medical

Device.

Original

Receipt

Undertaking

of acceptance

of T&C of

PQD

Apply on

online

portal

(PQOD)

Valid US FDA

approval

certification

or

prequalificati

on by WHO

Device

Enlistment

Certificate

Undertaking

for Required

storage

temperature

as per

product's

requirement

Valid Sole

Agency

Agreement of

quoted item

foratleast

one year (for

importers)

Undertaking

for

Spurious/Adu

lterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP

since 01-01-

2020

Undertaking

for any

punitive

action taken

by PQCB

since 01-01-

2020

Status Remarks

22Nipro Medical Pvt

Ltd3

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 3ml with

needle (Blister

Pack)

100

JMI

Syringes &

Medical

Devices Ltd.

JMI AD

Syringe3cc Bangladesh Yes Yes Yes Yes Yes N/A No Yes Yes No No N/A N/A No N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

2. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

3. The firm did not submit valid

registration of manufacturing firm with

chamber of commerce from country of

manufacturer.

4. The firm did not attach undertaking for

the clause no. 14 of the firm wise

knockdown criteria of prequalification

document.

23Nipro Medical Pvt

Ltd4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

100

JMI

Syringes &

Medical

Devices Ltd.

JMI AD

Syringe5cc Bangladesh Yes Yes Yes Yes Yes N/A No Yes Yes No No N/A N/A No N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

2. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

3. The firm did not submit valid

registration of manufacturing firm with

chamber of commerce from country of

manufacturer.

4. The firm did not attach undertaking for

the clause no. 14 of the firm wise

knockdown criteria of prequalification

document.

24Nipro Medical Pvt

Ltd5

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 0.5ml

with needle

(Blister Pack)

100

JMI

Syringes &

Medical

Devices Ltd.

JMI AD

Syringe0.5cc Bangladesh Yes Yes Yes Yes Yes N/A No Yes Yes No No N/A N/A No N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

2. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

3. The firm did not submit valid

registration of manufacturing firm with

chamber of commerce from country of

manufacturer.

4. The firm did not attach undertaking for

the clause no. 14 of the firm wise

knockdown criteria of prequalification

document.

25Nipro Medical Pvt

Ltd6

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 1ml with

needle (Blister

Pack)

100

JMI

Syringes &

Medical

Devices Ltd.

JMI AD

Syringe1cc Bangladesh Yes Yes Yes Yes Yes N/A No Yes Yes No No N/A N/A No N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

2. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

3. The firm did not submit valid

registration of manufacturing firm with

chamber of commerce from country of

manufacturer.

4. The firm did not attach undertaking for

the clause no. 14 of the firm wise

knockdown criteria of prequalification

document.

Page 4 of 7

Page 34: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of AD/RUP Syringes for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By

Quoted

BrandStrength

Country of

Origin

Valid License

to

Manufacture/

Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking of

valid sole

agency

agreement

Undertaking of

not

blacklisted/

debarred by

any procuring

agency.

Firm will

provide

valid ISO

13485.

Valid GMP

(For local

manufactu

rer)

Valid

CE/UNFPA

/JMHLW/

US FDA

approval

certificati

on or

prequalific

ation by

WHO

Undertaking of

Proper

warehouseproper

warehouse and

storage facility as

per

recommendation

of the

manufacturer and

at required

temperature and

follows good

storage and

distribution

practice. Firm will

provide

undertaking on

legally notarized

stamp paper of

rupees 100.

Procuring Agency

may physically

verify firm’s

claim. Firm must

mention address

of its storage

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufactu

rer only)

Undertaking

following

labor laws

(For

manufacture

r only)

Undertaking

of its supplied

batch in

Public Sector

Institutions

has been

declared

Spurious/Adul

terated

Form-29

issued by

SECP.

(Article of

association

of

companies)

/Form C

(Registered

from

registrar of

firms)/ sole

proprietors

hip. (For

manufactur

er only)

Undertaking

of Non

prosecuted

by PQCB on

the offense

of

Spurious/Ad

ulterated

Medical

Device.

Original

Receipt

Undertaking

of acceptance

of T&C of

PQD

Apply on

online

portal

(PQOD)

Valid US FDA

approval

certification

or

prequalificati

on by WHO

Device

Enlistment

Certificate

Undertaking

for Required

storage

temperature

as per

product's

requirement

Valid Sole

Agency

Agreement of

quoted item

foratleast

one year (for

importers)

Undertaking

for

Spurious/Adu

lterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP

since 01-01-

2020

Undertaking

for any

punitive

action taken

by PQCB

since 01-01-

2020

Status Remarks

26 Nisa . SF 1

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 10 ml

with needle

(Blister Pack)

100NISA . SF

(Pvt) LtdBM 10cc Pakistan No N/A N/A Yes No No No No Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes N/A Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach valid Device

Manufacturing License of auto disable

syringes.

2. The firm did not submit valid ISO 13485.

3. The firm did not submit valid GMP

certificate.

4. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

5. The firm did not attach undertaking for

the clause no.8 of the firm wise

knockdown criteria of prequalification

document.

27 Nisa . SF 3

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 3ml with

needle (Blister

Pack)

100NISA . SF

(Pvt) LtdBM 3cc Pakistan No N/A N/A Yes No No No No Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes N/A Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach valid Device

Manufacturing License of auto disable

syringes.

2. The firm did not submit valid ISO 13485.

3. The firm did not submit valid GMP

certificate.

4. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

5. The firm did not attach undertaking for

the clause no.8 of the firm wise

knockdown criteria of prequalification

document.

28 Nisa . SF 4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

100NISA . SF

(Pvt) LtdBM 5cc Pakistan No N/A N/A Yes No No No No Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes N/A Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach valid Device

Manufacturing License of auto disable

syringes.

2. The firm did not submit valid ISO 13485.

3. The firm did not submit valid GMP

certificate.

4. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

5. The firm did not attach undertaking for

the clause no.8 of the firm wise

knockdown criteria of prequalification

document.

29 Nisa . SF 6

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 1ml with

needle (Blister

Pack)

100NISA . SF

(Pvt) LtdBM 1ML Pakistan No N/A N/A Yes No No No No Yes Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes N/A Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach valid Device

Manufacturing License of auto disable

syringes.

2. The firm did not submit valid ISO 13485.

3. The firm did not submit valid GMP

certificate.

4. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

5. The firm did not attach undertaking for

the clause no.8 of the firm wise

knockdown criteria of prequalification

document.

30Nisa Impex

(Private) Limited1

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 10 ml

with needle

(Blister Pack)

100

Chengdu

Xinjin

Shifeng

Medical

Apparatus

&

Instrument

Co. Ltd

NISA 10cc China Yes Yes Yes Yes Yes N/A No Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

31Nisa Impex

(Private) Limited2

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 2ml with

needle (Blister

Pack)

100

Chengdu

Xinjin

Shifeng

Medical

Apparatus

&

Instrument

Co. Ltd

NISA 2cc China Yes Yes Yes Yes Yes N/A No Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

Page 5 of 7

Page 35: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of AD/RUP Syringes for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By

Quoted

BrandStrength

Country of

Origin

Valid License

to

Manufacture/

Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking of

valid sole

agency

agreement

Undertaking of

not

blacklisted/

debarred by

any procuring

agency.

Firm will

provide

valid ISO

13485.

Valid GMP

(For local

manufactu

rer)

Valid

CE/UNFPA

/JMHLW/

US FDA

approval

certificati

on or

prequalific

ation by

WHO

Undertaking of

Proper

warehouseproper

warehouse and

storage facility as

per

recommendation

of the

manufacturer and

at required

temperature and

follows good

storage and

distribution

practice. Firm will

provide

undertaking on

legally notarized

stamp paper of

rupees 100.

Procuring Agency

may physically

verify firm’s

claim. Firm must

mention address

of its storage

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufactu

rer only)

Undertaking

following

labor laws

(For

manufacture

r only)

Undertaking

of its supplied

batch in

Public Sector

Institutions

has been

declared

Spurious/Adul

terated

Form-29

issued by

SECP.

(Article of

association

of

companies)

/Form C

(Registered

from

registrar of

firms)/ sole

proprietors

hip. (For

manufactur

er only)

Undertaking

of Non

prosecuted

by PQCB on

the offense

of

Spurious/Ad

ulterated

Medical

Device.

Original

Receipt

Undertaking

of acceptance

of T&C of

PQD

Apply on

online

portal

(PQOD)

Valid US FDA

approval

certification

or

prequalificati

on by WHO

Device

Enlistment

Certificate

Undertaking

for Required

storage

temperature

as per

product's

requirement

Valid Sole

Agency

Agreement of

quoted item

foratleast

one year (for

importers)

Undertaking

for

Spurious/Adu

lterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP

since 01-01-

2020

Undertaking

for any

punitive

action taken

by PQCB

since 01-01-

2020

Status Remarks

32Nisa Impex

(Private) Limited3

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 3ml with

needle (Blister

Pack)

100

Chengdu

Xinjin

Shifeng

Medical

Apparatus

&

Instrument

Co. Ltd

NISA 3cc China Yes Yes Yes Yes Yes N/A No Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

33Nisa Impex

(Private) Limited4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

100

Chengdu

Xinjin

Shifeng

Medical

Apparatus

&

Instrument

Co. Ltd

NISA 5cc China Yes Yes Yes Yes Yes N/A No Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

34Nisa Impex

(Private) Limited6

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 1ml with

needle (Blister

Pack)

100

Chengdu

Xinjin

Shifeng

Medical

Apparatus

&

Instrument

Co. Ltd

NISA 1cc China Yes Yes Yes Yes Yes N/A No Yes Yes Yes Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

35Platinum

Corporation1

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 10 ml

with needle

(Blister Pack)

100

Yangzhou

Medline

Industry

CO. LTD.

Yangzhou,

China

Medline 21G 1 1/2" China Yes Yes Yes Yes Yes N/A No Yes Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

2. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

36Platinum

Corporation3

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 3ml with

needle (Blister

Pack)

100

Yangzhou

Medline

Industry

CO. LTD.

Yangzhou,

China

Medline 23G 1" China Yes Yes Yes Yes Yes N/A No Yes Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

2. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

37Platinum

Corporation4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

100

Yangzhou

Medline

Industry

CO. LTD.

Yangzhou,

China

Medline 23G 1" China Yes Yes Yes Yes Yes N/A No Yes Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes YesNot-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

2. The Annual financial turnover of the

firm is less than the required Minimum

Annual financial turnover i.e., 330 Million

as per clause no. 10 of the firm wise

knockdown criteria of the prequalification

document.

38Silver Surgical

Complex (Pvt.)

Ltd

4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

1

Silver

Surgical

Complex

(Pvt.) Ltd

ORANGE 5ml Pakistan Yes N/A N/A No Yes Yes No No No Yes N/A Yes No No Yes No Yes No Yes No Yes No N/A No No No No NoNot-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

2. The firm did not attach undertakings for

the clause no. 4, 8,9, 13, 14, 16 & 18 of the

firm wise knockdown criteria of

prequalification document.

3. The firm did not attach undertakings for

the clause no. 3, 6, 7,8,9 & 10 of the

product wise knockdown criteria of

prequalification document.

39 SY'AH IMPEX 3

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 3ml with

needle (Blister

Pack)

100

CHANGZHO

U TONGDA

MEDICAL

APPLIANCE

CO LTD

SHIFASINGLE

PACKChina Yes Yes Yes Yes Yes N/A Yes No Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes No Yes Yes Yes No No Yes

Not-

Prequalified

1. The firm did not attach FBR

sales/income tax returns of last three

financial/calendar years.

2. The firm did not attach undertaking for

the clause no. 8 of the firm wise

knockdown criteria of prequalification

document.

3. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of

prequalification document.

Page 6 of 7

Page 36: Undertaking of Proper Information provided at CE/UNFP

Evaluation Report for the Prequalification of AD/RUP Syringes for the FY 2021-22

Sr.Company

Name

Item

CodeGeneric Name

Pack

SizeMfg By

Quoted

BrandStrength

Country of

Origin

Valid License

to

Manufacture/

Import

Medical

Devices

DSL (For

Sole

agent)

Undertaking of

valid sole

agency

agreement

Undertaking of

not

blacklisted/

debarred by

any procuring

agency.

Firm will

provide

valid ISO

13485.

Valid GMP

(For local

manufactu

rer)

Valid

CE/UNFPA

/JMHLW/

US FDA

approval

certificati

on or

prequalific

ation by

WHO

Undertaking of

Proper

warehouseproper

warehouse and

storage facility as

per

recommendation

of the

manufacturer and

at required

temperature and

follows good

storage and

distribution

practice. Firm will

provide

undertaking on

legally notarized

stamp paper of

rupees 100.

Procuring Agency

may physically

verify firm’s

claim. Firm must

mention address

of its storage

Information

provided at

Annexure-A,

B,C, and E or

any other

information

provided in

accordance

with terms &

conditions of

the PQD

Minimum

Annual

financial

turnover

Valid

registration of

manufacturing

firm with

chamber of

commerce from

country of

manufacturer.

Building

fitness

certificate

(For

manufactu

rer only)

Undertaking

following

labor laws

(For

manufacture

r only)

Undertaking

of its supplied

batch in

Public Sector

Institutions

has been

declared

Spurious/Adul

terated

Form-29

issued by

SECP.

(Article of

association

of

companies)

/Form C

(Registered

from

registrar of

firms)/ sole

proprietors

hip. (For

manufactur

er only)

Undertaking

of Non

prosecuted

by PQCB on

the offense

of

Spurious/Ad

ulterated

Medical

Device.

Original

Receipt

Undertaking

of acceptance

of T&C of

PQD

Apply on

online

portal

(PQOD)

Valid US FDA

approval

certification

or

prequalificati

on by WHO

Device

Enlistment

Certificate

Undertaking

for Required

storage

temperature

as per

product's

requirement

Valid Sole

Agency

Agreement of

quoted item

foratleast

one year (for

importers)

Undertaking

for

Spurious/Adu

lterated

Samples for

quoted item

Undertaking

for

substandard

samples of

quoted item

not over 5%

since 01-01-

2020

Undertaking

for

substandard

batch recall

history since

01-01-2020

Undertaking

for any

punitive

action taken

by DRAP

since 01-01-

2020

Undertaking

for any

punitive

action taken

by PQCB

since 01-01-

2020

Status Remarks

40 SY'AH IMPEX 4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

100

CHANGZHO

U TONGDA

MEDICAL

APPLIANCE

CO LTD

SHIFASINGLE

PACKChina Yes Yes Yes Yes Yes N/A Yes No Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes No Yes Yes Yes No No Yes

Not-

Prequalified

1. The firm did not attach FBR

sales/income tax returns of last three

financial/calendar years.

2. The firm did not attach undertaking for

the clause no. 8 of the firm wise

knockdown criteria of prequalification

document.

3. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of

prequalification document.

41 SY'AH IMPEX 5

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 0.5ml

with needle

(Blister Pack)

100

CHANGZHO

U TONGDA

MEDICAL

APPLIANCE

CO LTD

SHIFASINGLE

PACKChina Yes Yes Yes Yes Yes N/A No No Yes No Yes N/A N/A Yes N/A Yes Yes Yes Yes No Yes No Yes Yes Yes No No Yes

Not-

Prequalified

1. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

2. The firm did not attach FBR

sales/income tax returns of last three

financial/calendar years.

3. The firm did not attach undertaking for

the clause no. 8 of the firm wise

knockdown criteria of prequalification

document.

4. The firm did not attach undertakings for

the clause no. 3, 6, 8 & 9 of the product

wise knockdown criteria of

prequalification document.

42UNISA (PVT)

Limited 3

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 3ml with

needle (Blister

Pack)

100Unisa Pvt

Ltd PakistanUNILOCK 3ml Pakistan No N/A N/A Yes No No No Yes Yes Yes N/A Yes Yes Yes Yes Yes Yes No Yes No Yes Yes N/A Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach valid Device

Manufacturing License of auto disable

syringes.

2. The firm did not submit valid ISO 13485.

3. The firm did not submit valid GMP

certificate.

4. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

5. The firm did not attach undertaking for

the clause no.18 of the firm wise

knockdown criteria of prequalification

document.

43UNISA (PVT)

Limited 4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

100Unisa Pvt

Ltd PakistanUNILOCK 5ml Pakistan No N/A N/A Yes No No No Yes Yes Yes N/A Yes Yes Yes Yes Yes Yes No Yes No Yes Yes N/A Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not attach valid Device

Manufacturing License of auto disable

syringes.

2. The firm did not submit valid ISO 13485.

3. The firm did not submit valid GMP

certificate.

4. The firm did not attach Valid JMHLW/US

FDA approval certification or

prequalification by WHO for the quoted

item.

5. The firm did not attach undertaking for

the clause no.18 of the firm wise

knockdown criteria of prequalification

document.

44Usmanco

International3

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 3ml with

needle (Blister

Pack)

100

JiangXi

Sanxin

Medtec Co.,

Ltd

Yixin Auto

Disable

Syringe

3 ml syringe

with NeedleChina Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not submit valid

registration of manufacturing firm with

chamber of commerce from country of

manufacturer.

45Usmanco

International4

Auto Disable

(AD)/Re-use

prevention (RUP)

Syringe 5 ml with

needle (Blister

Pack)

100

JiangXi

Sanxin

Medtec Co.,

Ltd

Yixin Auto

Disable

Syringe

5 ml syringe

with NeedleChina Yes Yes Yes Yes Yes N/A Yes Yes Yes Yes No N/A N/A Yes N/A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Not-

Prequalified

1. The firm did not submit valid

registration of manufacturing firm with

chamber of commerce from country of

manufacturer.

Page 7 of 7