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Introduction of Institute for Testing and Certification & ITC ASIA April 2011

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Page 1: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Introduction of Institute for Testing and Certification

amp

ITC ASIA

April 2011

Company profile

Foundation in 1969 ndash State testing department RPTRI (VUGPT)

Since 2000 ITC ndash private company The largest private

institute on similar services in CR by the Czech capital

The ITC is accredited according to EN ISO standards as

Testing Laboratory Certification body for products

Certification body for systems Inspection body Calibration

laboratory

It is a Notified Body No 1023 for several sectors

(httpeceuropaeuenterprisenewapproachnando)

Company profile

Company profile

The ITC is member of various organizations and has

contacts with many institutions (administration

lobby-groups universities CEN ISO etc)

The ITC is most likely offering the broadest range

of services of this kind in the Czech Republic

Company profile

Testing laboratory services

rubber plastics

chemicals

foodstuffs

textile leather footwear

construction products

glass paper

pharmaceutical

gas petrochemicals

woodworking industries

gaming machines

machinery

electrical and optical products

automotive aircraft industries

Product and material testing

in the accredited laboratory

Hygienic properties

Contact with human skin

Contact with drinking water

Contact with foodstuffs

Products for children under 3 years of age

Microbiological issues

Occupational hygiene

Foods quality

Products and material testing

in the accredited laboratory

Accredited testing laboratory

No 1004 Certificate of Accreditation

Products Certification

Toys (Directive 88378EEC)

Personal protective equipment (Directive 89686EEC)

Construction products (CE marked) (Directive 89106EEC)

Medical devices (Directive 9342EEC)

Active implantable medical devices (Directive 90385EEC)

In vitro diagnostic medical devices (Directive 9879EC)

Low-voltage electrical equipment (Directive 200695EC)

Electromagnetic compatibility (Directive 2004108EC)

Pressure equipment (Press Cookers) (Directive 9723EC)

Products conformity assessment according to

requirements of European directives

Playground equipment (Gov Order No 1731997 Coll)

Construction products (Gov Order No 1631997 Coll)

Products conformity assessment related to

specific Czech laws

Products Certification

Products Certification

rubber and plastics chemicals

coal and petroleum products

foods and foodstuffs

textile and clothing

leather and leather products

construction products and materials

mineral and rock based raw-materials

machinery electrical and office equipment

medical devices

toys games children playground equipment

sporting goods floorball equipment (IFF approved)

water cosmetics

Products certification by the ITC Accredited

Certification Body (in the non-regulated sphere)

Product certification body

No 3020 Certificate of Accreditation

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 2: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Company profile

Foundation in 1969 ndash State testing department RPTRI (VUGPT)

Since 2000 ITC ndash private company The largest private

institute on similar services in CR by the Czech capital

The ITC is accredited according to EN ISO standards as

Testing Laboratory Certification body for products

Certification body for systems Inspection body Calibration

laboratory

It is a Notified Body No 1023 for several sectors

(httpeceuropaeuenterprisenewapproachnando)

Company profile

Company profile

The ITC is member of various organizations and has

contacts with many institutions (administration

lobby-groups universities CEN ISO etc)

The ITC is most likely offering the broadest range

of services of this kind in the Czech Republic

Company profile

Testing laboratory services

rubber plastics

chemicals

foodstuffs

textile leather footwear

construction products

glass paper

pharmaceutical

gas petrochemicals

woodworking industries

gaming machines

machinery

electrical and optical products

automotive aircraft industries

Product and material testing

in the accredited laboratory

Hygienic properties

Contact with human skin

Contact with drinking water

Contact with foodstuffs

Products for children under 3 years of age

Microbiological issues

Occupational hygiene

Foods quality

Products and material testing

in the accredited laboratory

Accredited testing laboratory

No 1004 Certificate of Accreditation

Products Certification

Toys (Directive 88378EEC)

Personal protective equipment (Directive 89686EEC)

Construction products (CE marked) (Directive 89106EEC)

Medical devices (Directive 9342EEC)

Active implantable medical devices (Directive 90385EEC)

In vitro diagnostic medical devices (Directive 9879EC)

Low-voltage electrical equipment (Directive 200695EC)

Electromagnetic compatibility (Directive 2004108EC)

Pressure equipment (Press Cookers) (Directive 9723EC)

Products conformity assessment according to

requirements of European directives

Playground equipment (Gov Order No 1731997 Coll)

Construction products (Gov Order No 1631997 Coll)

Products conformity assessment related to

specific Czech laws

Products Certification

Products Certification

rubber and plastics chemicals

coal and petroleum products

foods and foodstuffs

textile and clothing

leather and leather products

construction products and materials

mineral and rock based raw-materials

machinery electrical and office equipment

medical devices

toys games children playground equipment

sporting goods floorball equipment (IFF approved)

water cosmetics

Products certification by the ITC Accredited

Certification Body (in the non-regulated sphere)

Product certification body

No 3020 Certificate of Accreditation

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 3: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Company profile

Company profile

The ITC is member of various organizations and has

contacts with many institutions (administration

lobby-groups universities CEN ISO etc)

The ITC is most likely offering the broadest range

of services of this kind in the Czech Republic

Company profile

Testing laboratory services

rubber plastics

chemicals

foodstuffs

textile leather footwear

construction products

glass paper

pharmaceutical

gas petrochemicals

woodworking industries

gaming machines

machinery

electrical and optical products

automotive aircraft industries

Product and material testing

in the accredited laboratory

Hygienic properties

Contact with human skin

Contact with drinking water

Contact with foodstuffs

Products for children under 3 years of age

Microbiological issues

Occupational hygiene

Foods quality

Products and material testing

in the accredited laboratory

Accredited testing laboratory

No 1004 Certificate of Accreditation

Products Certification

Toys (Directive 88378EEC)

Personal protective equipment (Directive 89686EEC)

Construction products (CE marked) (Directive 89106EEC)

Medical devices (Directive 9342EEC)

Active implantable medical devices (Directive 90385EEC)

In vitro diagnostic medical devices (Directive 9879EC)

Low-voltage electrical equipment (Directive 200695EC)

Electromagnetic compatibility (Directive 2004108EC)

Pressure equipment (Press Cookers) (Directive 9723EC)

Products conformity assessment according to

requirements of European directives

Playground equipment (Gov Order No 1731997 Coll)

Construction products (Gov Order No 1631997 Coll)

Products conformity assessment related to

specific Czech laws

Products Certification

Products Certification

rubber and plastics chemicals

coal and petroleum products

foods and foodstuffs

textile and clothing

leather and leather products

construction products and materials

mineral and rock based raw-materials

machinery electrical and office equipment

medical devices

toys games children playground equipment

sporting goods floorball equipment (IFF approved)

water cosmetics

Products certification by the ITC Accredited

Certification Body (in the non-regulated sphere)

Product certification body

No 3020 Certificate of Accreditation

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 4: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Company profile

The ITC is member of various organizations and has

contacts with many institutions (administration

lobby-groups universities CEN ISO etc)

The ITC is most likely offering the broadest range

of services of this kind in the Czech Republic

Company profile

Testing laboratory services

rubber plastics

chemicals

foodstuffs

textile leather footwear

construction products

glass paper

pharmaceutical

gas petrochemicals

woodworking industries

gaming machines

machinery

electrical and optical products

automotive aircraft industries

Product and material testing

in the accredited laboratory

Hygienic properties

Contact with human skin

Contact with drinking water

Contact with foodstuffs

Products for children under 3 years of age

Microbiological issues

Occupational hygiene

Foods quality

Products and material testing

in the accredited laboratory

Accredited testing laboratory

No 1004 Certificate of Accreditation

Products Certification

Toys (Directive 88378EEC)

Personal protective equipment (Directive 89686EEC)

Construction products (CE marked) (Directive 89106EEC)

Medical devices (Directive 9342EEC)

Active implantable medical devices (Directive 90385EEC)

In vitro diagnostic medical devices (Directive 9879EC)

Low-voltage electrical equipment (Directive 200695EC)

Electromagnetic compatibility (Directive 2004108EC)

Pressure equipment (Press Cookers) (Directive 9723EC)

Products conformity assessment according to

requirements of European directives

Playground equipment (Gov Order No 1731997 Coll)

Construction products (Gov Order No 1631997 Coll)

Products conformity assessment related to

specific Czech laws

Products Certification

Products Certification

rubber and plastics chemicals

coal and petroleum products

foods and foodstuffs

textile and clothing

leather and leather products

construction products and materials

mineral and rock based raw-materials

machinery electrical and office equipment

medical devices

toys games children playground equipment

sporting goods floorball equipment (IFF approved)

water cosmetics

Products certification by the ITC Accredited

Certification Body (in the non-regulated sphere)

Product certification body

No 3020 Certificate of Accreditation

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 5: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Company profile

Testing laboratory services

rubber plastics

chemicals

foodstuffs

textile leather footwear

construction products

glass paper

pharmaceutical

gas petrochemicals

woodworking industries

gaming machines

machinery

electrical and optical products

automotive aircraft industries

Product and material testing

in the accredited laboratory

Hygienic properties

Contact with human skin

Contact with drinking water

Contact with foodstuffs

Products for children under 3 years of age

Microbiological issues

Occupational hygiene

Foods quality

Products and material testing

in the accredited laboratory

Accredited testing laboratory

No 1004 Certificate of Accreditation

Products Certification

Toys (Directive 88378EEC)

Personal protective equipment (Directive 89686EEC)

Construction products (CE marked) (Directive 89106EEC)

Medical devices (Directive 9342EEC)

Active implantable medical devices (Directive 90385EEC)

In vitro diagnostic medical devices (Directive 9879EC)

Low-voltage electrical equipment (Directive 200695EC)

Electromagnetic compatibility (Directive 2004108EC)

Pressure equipment (Press Cookers) (Directive 9723EC)

Products conformity assessment according to

requirements of European directives

Playground equipment (Gov Order No 1731997 Coll)

Construction products (Gov Order No 1631997 Coll)

Products conformity assessment related to

specific Czech laws

Products Certification

Products Certification

rubber and plastics chemicals

coal and petroleum products

foods and foodstuffs

textile and clothing

leather and leather products

construction products and materials

mineral and rock based raw-materials

machinery electrical and office equipment

medical devices

toys games children playground equipment

sporting goods floorball equipment (IFF approved)

water cosmetics

Products certification by the ITC Accredited

Certification Body (in the non-regulated sphere)

Product certification body

No 3020 Certificate of Accreditation

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 6: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Testing laboratory services

rubber plastics

chemicals

foodstuffs

textile leather footwear

construction products

glass paper

pharmaceutical

gas petrochemicals

woodworking industries

gaming machines

machinery

electrical and optical products

automotive aircraft industries

Product and material testing

in the accredited laboratory

Hygienic properties

Contact with human skin

Contact with drinking water

Contact with foodstuffs

Products for children under 3 years of age

Microbiological issues

Occupational hygiene

Foods quality

Products and material testing

in the accredited laboratory

Accredited testing laboratory

No 1004 Certificate of Accreditation

Products Certification

Toys (Directive 88378EEC)

Personal protective equipment (Directive 89686EEC)

Construction products (CE marked) (Directive 89106EEC)

Medical devices (Directive 9342EEC)

Active implantable medical devices (Directive 90385EEC)

In vitro diagnostic medical devices (Directive 9879EC)

Low-voltage electrical equipment (Directive 200695EC)

Electromagnetic compatibility (Directive 2004108EC)

Pressure equipment (Press Cookers) (Directive 9723EC)

Products conformity assessment according to

requirements of European directives

Playground equipment (Gov Order No 1731997 Coll)

Construction products (Gov Order No 1631997 Coll)

Products conformity assessment related to

specific Czech laws

Products Certification

Products Certification

rubber and plastics chemicals

coal and petroleum products

foods and foodstuffs

textile and clothing

leather and leather products

construction products and materials

mineral and rock based raw-materials

machinery electrical and office equipment

medical devices

toys games children playground equipment

sporting goods floorball equipment (IFF approved)

water cosmetics

Products certification by the ITC Accredited

Certification Body (in the non-regulated sphere)

Product certification body

No 3020 Certificate of Accreditation

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 7: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Hygienic properties

Contact with human skin

Contact with drinking water

Contact with foodstuffs

Products for children under 3 years of age

Microbiological issues

Occupational hygiene

Foods quality

Products and material testing

in the accredited laboratory

Accredited testing laboratory

No 1004 Certificate of Accreditation

Products Certification

Toys (Directive 88378EEC)

Personal protective equipment (Directive 89686EEC)

Construction products (CE marked) (Directive 89106EEC)

Medical devices (Directive 9342EEC)

Active implantable medical devices (Directive 90385EEC)

In vitro diagnostic medical devices (Directive 9879EC)

Low-voltage electrical equipment (Directive 200695EC)

Electromagnetic compatibility (Directive 2004108EC)

Pressure equipment (Press Cookers) (Directive 9723EC)

Products conformity assessment according to

requirements of European directives

Playground equipment (Gov Order No 1731997 Coll)

Construction products (Gov Order No 1631997 Coll)

Products conformity assessment related to

specific Czech laws

Products Certification

Products Certification

rubber and plastics chemicals

coal and petroleum products

foods and foodstuffs

textile and clothing

leather and leather products

construction products and materials

mineral and rock based raw-materials

machinery electrical and office equipment

medical devices

toys games children playground equipment

sporting goods floorball equipment (IFF approved)

water cosmetics

Products certification by the ITC Accredited

Certification Body (in the non-regulated sphere)

Product certification body

No 3020 Certificate of Accreditation

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 8: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Accredited testing laboratory

No 1004 Certificate of Accreditation

Products Certification

Toys (Directive 88378EEC)

Personal protective equipment (Directive 89686EEC)

Construction products (CE marked) (Directive 89106EEC)

Medical devices (Directive 9342EEC)

Active implantable medical devices (Directive 90385EEC)

In vitro diagnostic medical devices (Directive 9879EC)

Low-voltage electrical equipment (Directive 200695EC)

Electromagnetic compatibility (Directive 2004108EC)

Pressure equipment (Press Cookers) (Directive 9723EC)

Products conformity assessment according to

requirements of European directives

Playground equipment (Gov Order No 1731997 Coll)

Construction products (Gov Order No 1631997 Coll)

Products conformity assessment related to

specific Czech laws

Products Certification

Products Certification

rubber and plastics chemicals

coal and petroleum products

foods and foodstuffs

textile and clothing

leather and leather products

construction products and materials

mineral and rock based raw-materials

machinery electrical and office equipment

medical devices

toys games children playground equipment

sporting goods floorball equipment (IFF approved)

water cosmetics

Products certification by the ITC Accredited

Certification Body (in the non-regulated sphere)

Product certification body

No 3020 Certificate of Accreditation

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 9: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Products Certification

Toys (Directive 88378EEC)

Personal protective equipment (Directive 89686EEC)

Construction products (CE marked) (Directive 89106EEC)

Medical devices (Directive 9342EEC)

Active implantable medical devices (Directive 90385EEC)

In vitro diagnostic medical devices (Directive 9879EC)

Low-voltage electrical equipment (Directive 200695EC)

Electromagnetic compatibility (Directive 2004108EC)

Pressure equipment (Press Cookers) (Directive 9723EC)

Products conformity assessment according to

requirements of European directives

Playground equipment (Gov Order No 1731997 Coll)

Construction products (Gov Order No 1631997 Coll)

Products conformity assessment related to

specific Czech laws

Products Certification

Products Certification

rubber and plastics chemicals

coal and petroleum products

foods and foodstuffs

textile and clothing

leather and leather products

construction products and materials

mineral and rock based raw-materials

machinery electrical and office equipment

medical devices

toys games children playground equipment

sporting goods floorball equipment (IFF approved)

water cosmetics

Products certification by the ITC Accredited

Certification Body (in the non-regulated sphere)

Product certification body

No 3020 Certificate of Accreditation

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 10: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Playground equipment (Gov Order No 1731997 Coll)

Construction products (Gov Order No 1631997 Coll)

Products conformity assessment related to

specific Czech laws

Products Certification

Products Certification

rubber and plastics chemicals

coal and petroleum products

foods and foodstuffs

textile and clothing

leather and leather products

construction products and materials

mineral and rock based raw-materials

machinery electrical and office equipment

medical devices

toys games children playground equipment

sporting goods floorball equipment (IFF approved)

water cosmetics

Products certification by the ITC Accredited

Certification Body (in the non-regulated sphere)

Product certification body

No 3020 Certificate of Accreditation

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 11: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Products Certification

rubber and plastics chemicals

coal and petroleum products

foods and foodstuffs

textile and clothing

leather and leather products

construction products and materials

mineral and rock based raw-materials

machinery electrical and office equipment

medical devices

toys games children playground equipment

sporting goods floorball equipment (IFF approved)

water cosmetics

Products certification by the ITC Accredited

Certification Body (in the non-regulated sphere)

Product certification body

No 3020 Certificate of Accreditation

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 12: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Product certification body

No 3020 Certificate of Accreditation

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 13: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Management systems certification

(Accredited services)

ISO 9001 Certification of quality management systems

ISO 13485 Certification of quality management systems in the medical devices manufacturer

OHSAS 18001 Certification of occupational safety

and health management system

ISO 14001 Environmental management certification

HACCP Certification of the system of critical

points in food industry

ISO 22000 Certification of Food Safety Management Systems (Requirements on Organization within Food Chain)

ISOTS 16949 Certification of quality management systems in Organization providing lot manufacture and spare parts production on the automotive industry

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 14: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Management systems

Certification body No 3002 Certificate of Accreditation

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 15: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Special services

Gaming Machine Testing

Technical inspection

Voluntary certification

ldquoITC certified qualityrdquo (certification mark)

ldquoSAFE TOYSrdquo (certification mark)

Product testing ITC ATEST

Calibration verification of

standards and meters

Environment analyses

working environment assessment

waste assessment

Technical standardization

Consumer tests

Expert opinions

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 16: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Location

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 17: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Establishment of ASIA ITC (2005~Present)

Exclusive Representative of ITC for whole Asian Countries

Establishment of ITC Beijing in China (2006~Present)

Establishment of USA Office in Los Angeles USA(2007~Present)

Establishment of ITC Hangzhou in China (2007~Present)

Establishment of ITC Guangzhou In China (2009~Present)

Cooperation with Cosmos Corporation in Japan (2009~Present)

Establishment of ITC Thailand in Bangkok Thailand (2010~Present)

History of ITC ASIA

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 18: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

ITC ASIA Websitehttpwwwasiaitccom

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 19: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

System Certification

Product Certification

Burden to the PL lawRequirement of

environment and safety

Necessity of certificates

cope with trade barrier

Enterprises

Create new clients through diversification of markets and increase profit

Recognition of

brand power

Service Strategy of ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 20: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

ITC can cover for all Products and all Conformity

Assessment Procedures to the MDD IVD and AIMDD

We have our own FDA Designated Agency in Los Angeles

USA for effective FDA projects

We can also support your KFDA registration

MHLW projects are effectively supported through our Global offices

(MHLW Class II GMP inspection performed by ASIA ITC Auditor)

Exclusive cooperation with Russian Medical Device Certification

Body ldquoCCMErdquo we can provide competitive services

ITCrsquos Strong Points

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 21: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

ITC ASIA Global Office

ITC ASIA ITC Zlin

ITC ASIA

- Korea

ITC ASIA

- ChinaITC ASIA

- Japan

ITC ASIA

- USA

ITC ASIA

- England

ITC ASIA

-Germany

Liaison

Office

Seoul Beijing

Hangzhou

Guangzhou

Los

Angeles

ITC ASIA

- Thailand

Bangkok

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23

Page 22: Institute for Testing and Certification ITC ASIApre.asiaitc.com/download/article/TFDA_Seminar/1.pdf · 2011. 5. 13. · Introduction of Institute for Testing and Certification & ITC

Thank you

wwwasiaitccom

itc0432hanmailnet

itc0432asiaitccom

23