korea testing certification - astm international · korea testing certification establishment 2010....

Korea Testing Certification

Regulations and Standards for Medical Device

Table of content

1. Introduction of KTC

2. Domestic medical device industry

3. Medical Device Regulation (MFDS)

4. Applied Standards

Korea Testing Certification 1

Part 1. Introduction of KTC

Introduction - KTC


Introduction - KTC

1970. 3 Establishment

Electric Appliances Safety

Inspection & Certification

Electronic Appliance

Quality Certification

EMC Testing/IC Card

Testing

Accredited ISO 17025(KOLAS)

Korea Machinery and

Petrochemical Testing Institute

1969. 4 Establishment

Meter Verification &

Inspection

Testing, Analysis,

Evaluation and

Quality Certification Program

for Medical Devices Testing

Accredited ISO

17025(KOLAS)

Korea Testing Certification Establishment 2010. 7. 8

National Standard Fundamental Law (Article 30, Section 3)

Korea Electric Testing

Institute


Measuring Instrument Type Approval,

Verification & Calibration

Testing ∙ Analysis ∙ Evaluation (Machinery

parts, Oil products, Marine pollution

inhibitor etc)

Children Rides Safety Certification

Industrial Products Safety Inspection &

Medical Devices Testing ∙ Inspection

Promotion of International Cooperation

KOLAS Calibration ∙ Testing ∙ Inspection

Agency Evaluation

KS Certification Audit, ESQ Certification,

Quality Certification (Q Mark), Technical

Guidance

Education · Publication · Data

Dissemination (Quantitative test officials,

Lubrication management training, etc)

KETI MPI

Electric Appliances Safety Certification &

Medical Devices Testing ∙ Inspection

Energy Efficiency Test

EMC (Electromagnetic Compatibility) Test

International Accredited Testing Authority

by IECEE CB scheme (7 Divisions ,78

Standards)

Overseas Certifications (26 Countries 46

Organizations )

Casino Equipment Inspection

Financial IC Card H/W Test Inspection

E-passport Test Inspection

Q-Mark Certification, Technical Guidance

KS Certification Test & Factory Inspection

KOLAS Authorized Test & Inspection

Introduction - KTC


Overseas Certification Business

NCB (Certification & Standard Team)

CBTL (KTC)

HOUS

TRON, OFF CBTL

(Onetech) CBTL (Estech)

※ Currently 15 Divisions

2 External laboratories as CBTLs.

CABL

Designated as NCB / CBTL from IECEE

Introduction - KTC

LITE

MED

EMC

BATT

HSTS

INST

MISC

BATT

PROT

TOOL

POW


Introduction - KTC

MOU Status

Mutual Recognition of conformity

Sweden (SEMKO)

Norway (NEMKO)

Netherlands

(Dekra)

Germany (TUV, VDE)

France (LCIE)

Canada (QPS, CSA)

USA (ETL, MET)

Brazil (NCC)

Argentina

(IRAM)

Japan (UL Japan, JET)

Thailand

(ITS)

Singapore

(ITS, TUV)

Activation of the certification of overseas


http://www.onetech.co.kr/cgi/proof.cgi?cmd=view&rno=15

http://www.flags.net/country.php?country=NETH&section=CURR

http://www.flags.net/country.php?country=GERM&section=CURR

http://www.flags.net/country.php?country=FRAN&section=CURR

http://www.flags.net/country.php?country=BRAZ&section=CURR

http://www.flags.net/country.php?country=ARGE&section=CURR

http://www.flags.net/country.php?country=JAPA&section=CURR

http://www.flags.net/country.php?country=THAL&section=CURR

http://www.flags.net/country.php?country=SING&section=CURR

KTC Medical Device Group support MFDS Approval in

- Type test

- GMP Audit , and

- STED(Summary Technical Documentation) evaluation

(Reviewing Technical documents)

Introduction – Medical Device Group


President

Vice President

Medical Device Group

Medical Device Center

- 13 members

- Safety Test for MFDS Approval

- CBTL in MED

Medical Supplies Evaluation Center

- 9 members

- Biocompatibility Test

- Physiochemical Test

GMP Audit Center

- 6 members

- GMP Audit

- Risk Management Evaluation

STED Assessment Center

- 4 members

- STED Assessment

(Organization Chart)



For MFDS Approval

• Designated as Medical Device testing institute by MFDS since 1997

• Designated as GMP Audit institute by MFDS since 2000

• Designated as Technical STED Evaluation (Documents Reviewing) institute

by MFDS since 2003 (Only for Class 2)

※ Most of Medical Devices can be evaluated for MFDS Approval in KTC

For NCB/CBTL in MED

• Designated as NCB/CBTL in MED since 2007

- Scope : IEC 60601-1(ed2, ed3 & ed3.1]

IEC 60601-1-11(ed1)

IEC 60601-1-6(ed3) & IEC 62366(ed1)

IEC 60601-2-10(ed1.1 & ed2)

IEC 60601-2-22(ed2, ed3, & ed3.1)



Part 2. Domestic medical device industry

Domestic medical device industry



Current status of the domestic medical device industry

■ Limitations

• Inferior in technology, capital, awareness, and etc.

• Dependent on imports for over 60 % of domestic demand.

(Expensive equipment Such as MRI, CT is dependent on import

up to 95%)

• Limitations on the market sharing of domestic small business

due to foreign preferred brand of domestic medical institutions.

• 2300 medical device manufacturers, but most are small business.

(Almost 80% of manufacturer sales less than 1 million USD)

• About 60% to 70% in Technical Level compare to developed countries.

• The lack of R & D human resources and the investment capacity.



Current status of the domestic medical device industry

■ Strengths

• Higher IT utilization

[The first place in Medical information systems penetration rate

in the world. (PACS, EMR)]

• Advanced medical personnel.

• Best Hospital building technology.

• Active medical device industry support policies of the government.


Part 3. Medical Device Regulation (MFDS)

Medical Device Regulation (MFDS)


Process flow for MFDS Approval/Permission of Medical Devices

Request to MFDS

Medical Device? Or Not?

STED Evaluation

(Reviewing of Technical Document)

Korean Agency

(Importer)

Import Business License and

Product Import License (MFDS)

Import Self test Sales

GMP Audit

(KTC & MFDS)

Type Test

(KTC)

Clinical Test Report

Import

requirement

check

< Imported product only >

Class 2 : KTC

Class 3 & 4 : MFDS 2. Request for

Document Review Issue the report of Reviewing

New concept medical

equipment

3. Request for Product License

Permission for

Sales in Korea

4. Request for GMP Audit

1. Request for Type Test

Test report

Approve the License



Request for Type Test

(to KTC)

Request for STED Evaluation

(Reviewing the Technical Documents)

(to KTC or MFDS)

Request for Import Business License and Product Import License (to MFDS)

Request for GMP Audit

(to KTC)

Sales in Korea (Import Self test Sales)

Test report (KTC)

Report of Reviewing of Technical Documents

License for Importing Product (MFDS)

Permission for Sales in Korea

Submission of Application form, Technical Documents, and Test Sample

Submission of Application form, Technical Documents, and Additional backup documents

Submission of

Application form, and Quality control-related Documents


Process flow for MFDS Approval/Permission of Medical Devices


Documents for Type Test

• Application form

• One test sample

• Technical document

• Customs entry related documents (Imported product only)

- Test sample confirmation document, and etc.



Documents for STED Evaluation (Reviewing of Technical documents) • Application form

• Additional Backup documents

- Data of Safety (Safety test report)

- Data of Biocompatibility (Biocompatibility report, if applicable)

- Data of Radiation safety (Radiation safety report, if applicable)

- Data of EMC Compatibility (EMC report)

- Data of Performance (Data of tests including preclinical

performance test such as function intended by the product, performance,

shelf life(available period), sterilization, animal experiment, etc.)

- Data of Physiochemical properties

(Physiochemical report, if applicable)



Documents for GMP Audit

• Application form

• Quality control-related documents

- Quality Management Manual

- DMR (Device Master Records)

- List of Manufacturing facilities and equipments.

- List of Test and Inspection facilities and equipments.

- Organization Chart including number of employees

- ISO 13485 Certificate, and etc.



Part 4. Applied Standards

Applied Standards


Applied Standards (MEE)

Medical Device

Act

(Product License

& KGMP)

ISO 14155 (Clinical Trials)

Safety - General

Collateral Standards

Particular Standards

Particular Standards

In Vitro Medical Devices

Active implantable medical devices

Biocompatibility


Relation of Major Standards for Medical Device


IEC 62304 (Software lifecycle

process)

IEC 60601-1 ed.3 (General Safety)

IEC 60601-1 -6 (Usability)

IEC 60601-1 -8 (Alarm system)

IEC 60601-1 -2 (EMC)

IEC 62366 (Usability engineering)

ISO 14971 (Risk management)

ISO 13485 (Quality management

systems)


Completion of the Technical Documentation


Completed Apply for

MFDS

Approval


Applied Standards (Biocompatibility)

Body Contact duration Test Standard

24 hr (Ex. Skin, mucosal membrane)

Cytotoxicity test ISO 10993-5

Sensitization test ISO 10993-10

Irritation test ISO 10993-10

24 hr ~ 30 days (Ex. Blood, tissue)

Systemic toxicity test ISO 10993-11

Pyrogenicity test ISO 10993-11

Hemocompatibility test ISO 10993-4

30 days (Ex. Bone, tissue)

Genotoxicity test ISO 10993-3 OECD guideline 471,473

Implantation test ISO 10993-6


Applied Standards (Performance test)

Test Standard

Physical/Chemical test

Aqueous Extract test KP or USP

Sterilization Sterility test KP

EO Residuals test ISO 10993-7

Bioburden test ISO 11737

Performance Performance test

(Ex. compression, tension, torsion)

ASTM F1717-10

ASTM F543-07

ASTM F88-00

ASTM F1929-98

Test Standard

Stability test

Accelerated Aging test ASTM F 1980


KI-IL NAM Principal Researcher Medical Device Center Korea Testing Certification [email protected]

mailto:[email protected]