undertaking of proper information provided at ce/unfp
TRANSCRIPT
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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