Regulations and Standards for Medical Device. Korea Testing Certification

Transcription

1 Regulations and Standards for Medical Device

2 Table of content 1. Introduction of KTC 2. Domestic medical device industry 3. Medical Device Regulation (MFDS) 4. Applied Standards 1

3 Introduction - KTC Part 1. Introduction of KTC 2

4 Introduction - KTC Korea Electric Testing Institute Korea Machinery and Petrochemical Testing Institute Establishment Electric Appliances Safety Inspection & Certification Electronic Appliance Quality Certification EMC Testing/IC Card Testing Accredited ISO 17025(KOLAS) Establishment Meter Verification & Inspection Testing, Analysis, Evaluation and Quality Certification Program for Medical Devices Testing Accredited ISO 17025(KOLAS) National Standard Fundamental Law (Article 30, Section 3) Establishment

5 Introduction - KTC KETI 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 MPI 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) 4

6 Introduction - KTC Overseas Certification Business Designated as NCB / CBTL from IECEE CBTL (KTC) NCB (Certification & Standard Team) HOUS TRON, OFF HSTS INST CBTL (Onetech) CBTL (Estech) CABL MISC LITE BATT MED PROT EMC BATT TOOL POW Currently 15 Divisions 2 External laboratories as CBTLs. 5

7 Introduction - KTC Activation of the certification of overseas MOU Status Thailand (ITS) Japan (UL Japan, JET) Singapore (ITS, TUV) Sweden (SEMKO) Norway (NEMKO) Netherlands (Dekra) Argentina (IRAM) Brazil (NCC) Mutual Recognition of conformity France (LCIE) Germany (TUV, VDE) USA (ETL, MET) Canada (QPS, CSA) 6

8 Introduction Medical Device Group KTC Medical Device Group support MFDS Approval in - Type test - GMP Audit, and - STED(Summary Technical Documentation) evaluation (Reviewing Technical documents) 7

9 Introduction Medical Device Group (Organization Chart) President Vice President Medical Device Group Medical Device Center Medical Supplies Evaluation Center GMP Audit Center STED Assessment Center - 13 members - Safety Test for MFDS Approval - CBTL in MED - 9 members - Biocompatibility Test - Physiochemical Test - 6 members - GMP Audit - Risk Management Evaluation - 4 members - STED Assessment 8

10 Introduction Medical Device Group 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 Scope : IEC (ed2, ed3 & ed3.1] IEC (ed1) IEC (ed3) & IEC 62366(ed1) IEC (ed1.1 & ed2) IEC (ed2, ed3, & ed3.1) 9

11 Domestic medical device industry Part 2. Domestic medical device industry 10

12 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 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. 11

13 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. 12

14 Medical Device Regulation (MFDS) Part 3. Medical Device Regulation (MFDS) 13

15 Medical Device Regulation (MFDS) 14

16 Medical Device Regulation (MFDS) 15

17 Medical Device Regulation (MFDS) 16

18 Medical Device Regulation (MFDS) Process flow for MFDS Approval/Permission of Medical Devices Request to MFDS Medical Device? Or Not? Class 2 : KTC Class 3 & 4 : MFDS STED Evaluation (Reviewing of Technical Document) 2. Request for Document Review Korean Agency (Importer) Issue the report of Reviewing New concept medical equipment 1. Request for Type Test Test report Clinical Test Report Type Test (KTC) GMP Audit (KTC & MFDS) 3. Request for Product License Import Business License and Product Import License (MFDS) 4. Request for GMP Audit Permission for Sales in Korea Approve the License Import requirement check < Imported product only > Import Self test Sales 17

19 Medical Device Regulation (MFDS) Process flow for MFDS Approval/Permission of Medical Devices Test report (KTC) Report of Reviewing of Technical Documents 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) License for Importing Product (MFDS) Request for GMP Audit (to KTC) 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 Sales in Korea (Import Self test Sales) 18

20 Medical Device Regulation (MFDS) Documents for Type Test Application form One test sample Technical document Customs entry related documents (Imported product only) - Test sample confirmation document, and etc. 19

21 Medical Device Regulation (MFDS) 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) 20

22 Medical Device Regulation (MFDS) 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 Certificate, and etc. 21

23 Applied Standards Part 4. Applied Standards 22

24 Applied Standards (MEE) Medical Device Act (Product License & KGMP) Safety - General Collateral Standards Particular Standards Particular Standards In Vitro Medical Devices ISO (Clinical Trials) Active implantable medical devices Biocompatibility 23

25 Applied Standards (MEE) Relation of Major Standards for Medical Device ISO (Quality management systems) IEC (Software lifecycle process) ISO (Risk management) IEC ed.3 (General Safety) IEC (EMC) IEC (Usability) IEC (Usability engineering) IEC (Alarm system) 24

26 Applied Standards (MEE) Completion of the Technical Documentation Completed Apply for MFDS Approval 25

27 Applied Standards (Biocompatibility) Body Contact duration Test Standard 24 hr (Ex. Skin, mucosal membrane) 24 hr ~ 30 days (Ex. Blood, tissue) Cytotoxicity test ISO Sensitization test ISO Irritation test ISO Systemic toxicity test ISO Pyrogenicity test ISO Hemocompatibility test ISO days (Ex. Bone, tissue) Genotoxicity test ISO OECD guideline 471,473 Implantation test ISO

28 Applied Standards (Performance test) Test Standard Physical/Chemical test Aqueous Extract test KP or USP Sterilization Sterility test KP EO Residuals test ISO Bioburden test ISO Performance Performance test (Ex. compression, tension, torsion) ASTM F ASTM F ASTM F88-00 ASTM F Test Standard Stability test Accelerated Aging test ASTM F

29 KI-IL NAM Principal Researcher Medical Device Center