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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
Korea Testing Certification 2
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
Korea Testing Certification 3
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
Korea Testing Certification 4
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
Korea Testing Certification 5
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
Korea Testing Certification 6
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
Korea Testing Certification 7
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)
Introduction – Medical Device Group
Korea Testing Certification 8
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)
Introduction – Medical Device Group
Korea Testing Certification 9
Part 2. Domestic medical device industry
Domestic medical device industry
Korea Testing Certification 10
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.
Korea Testing Certification 11
Domestic medical device industry
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.
Korea Testing Certification 12
Part 3. Medical Device Regulation (MFDS)
Medical Device Regulation (MFDS)
Korea Testing Certification 13
Medical Device Regulation (MFDS)
Korea Testing Certification 14
Medical Device Regulation (MFDS)
Korea Testing Certification 15
Medical Device Regulation (MFDS)
Korea Testing Certification 16
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
Medical Device Regulation (MFDS)
Korea Testing Certification 17
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
Medical Device Regulation (MFDS)
Process flow for MFDS Approval/Permission of Medical Devices
Korea Testing Certification 18
Documents for Type Test
• Application form
• One test sample
• Technical document
• Customs entry related documents (Imported product only)
- Test sample confirmation document, and etc.
Medical Device Regulation (MFDS)
Korea Testing Certification 19
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)
Medical Device Regulation (MFDS)
Korea Testing Certification 20
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.
Medical Device Regulation (MFDS)
Korea Testing Certification 21
Part 4. Applied Standards
Applied Standards
Korea Testing Certification 22
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
Korea Testing Certification 23
Relation of Major Standards for Medical Device
Applied Standards (MEE)
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)
Korea Testing Certification 24
Completion of the Technical Documentation
Applied Standards (MEE)
Completed Apply for
MFDS
Approval
Korea Testing Certification 25
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
Korea Testing Certification 26
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
Korea Testing Certification 27
KI-IL NAM Principal Researcher Medical Device Center Korea Testing Certification [email protected]