UL Webinar - Updates to the Regulatory Framework in Korea and their impact to IVD and Medical Device Submissions and Important Deadlines

1. UL and the UL logo are trademarks of UL LLC © 2013 Updates to the Regulatory Framework in Korea-Impact to IVD and Medical Device Submissions and Important Deadlines 23 July 2013 MinYong Choi LHS Senior Technical Consultant Life and Health Sciences BU UL Korea, Ltd.

2. MinYong Choi Background: • ISO 13485 Auditor & CE MDD Assessor, DNV Business Assurance(2011~2012) • Technical Reviewer, Medical Device Evaluation Department, KFDA(2005~2011) • Bachelor’s Degree in Computer Engineering, HoSeo University • Master's Degree in Software Engineering, HoSeo University Additional experiences: • Member of the ISO TC 215 (Health Informatics) Technical Committee(2007~Present) • Wrote the KFDA Technical Guidance for Medical Device Software, 2007 2 MinYong Choi is a Senior Technical Consultant for UL Life and Health Sciences Business Unit. He is responsible for developing and managing the MDRS(Medical Device Regulatory Support) business in Korea. He is an expert for medical device software and RLR candidate for medical device software in UL AP region.

3. Agenda. Regulatory Framework of Medical Device in Korea Recent & Upcoming Regulatory Changes 2012 Medical Device Market in Korea Useful Links UL One-stop Services 3

4. Chapter 1. Regulatory Framework of Medical Device in Korea Recent & Upcoming Regulatory Changes 2012 Medical Device Market in Korea Useful Links UL One-stop Services 4

5. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Capital: Seoul Language: Korean Area: 100,210 ㎢ Population: approx. 50 million Republic of Korea (South Korea) 5

6. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Ministry of Food and Drug Safety(MFDS) 6 Headquartered in O-Song: − Moved from Seoul to O-Song city(the Bio- Health Techno-polis) in November 2010 − 1760 employee are working in MFDS − It takes 30 minutes from Seoul to O-Song by KTX Seoul O-Song

7. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Organization for Medical Device in MFDS 7 7 Ministry of Food and Drug Safety Medical Device Safety Bureau Medical Device Policy Division Medical Device Quality Division Medical Device Management Division National Institute of Food and Drug Safety Evaluation Medical Device Evaluation Department High-tech Medical Devices Division Orthopedic and Restorative Devices Division Cardiovascular Devices Division Dental and Gastroenterology Devices Division Regional Food and Drug Administration Seoul Regional FDA GyeongIn Regional FDA Busan Regional FDA DaeGu Regional FDA DaeJeon Regional FDA GwangJu Regional FDA Medical Device Safety Management Division Medical Products Safety Division Medical Products Safety Division Medical Products Safety Division Medical Products Safety Division Medical Products Safety Division IVD Device and Reagent Task Force

9. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. History of Korea Medical Device Regulations 9 Pharmaceutical Affairs Act provides the definition of medical devices Introduce a regulatory system for licensing manufacturing business and product approval Introduce the requirements for production control and reporting KFDA established Introduce the classification system of medical devices based on risk level(3 classes) Implement regulations for good manufacturing practices Introduce two different pre-market pathways: (1) notification; and (2) approval Eliminate local testing requirements for each and every shipments of imported medical devices Legislate Medical Device Act Changed to a four-class system Begin regulating device import business, refurbishing business and rental business Strengthen post-market surveillance system Implement full-scale KGMP/GIP regulations KFDA reorganized as MFDS

10. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Structure of MFDS Medical Device Regulations 10 Medical Device Act (MDA)Act Presidential Decree MFDS Ministerial Regulations MFDS Minister Notifications Enforcement Regulations of MDA Implementing Regulations of MDA MFDS Notifications of MDA  Notifications for detailed requirements supporting Act and Ministerial Regulations MFDS Technical Guidelines & Example Documents on Specific Requirements

11. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. MFDS Medical Device Regulations 11 Conception Development Manufacture Package Labeling Adverting Sale Use Disposal Manufacturer Vendor User Pre-Market Post-Market • Device Business License −Manufacturing, Importing, Refurbishing, Distributing, Rental Business • Product Notification/Approval −Clinical Investigation Plan Approval • Quality System Certification −Korea Good Manufacturing Practice(KGMP) • Quality System Regulation • Labeling Requirements • Review of Advertisement • Medical Device Tracking • Adverse Event & Safety Alert Reporting • Re-evaluation • Re-examination • Recall • Inspects and Audits

12. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Product Classification • Four classes based on potential risk to human health and purpose of use • Harmonized with GHTF rules 12 Class Risk Device Examples I Little Trial Lens Set, Skin Staple, Surgical Light, Electrically- powered Table II Low Umbilical cord clip, Infusion pump, PACS III Moderate Silk Suture, Contact lens IV High Coronary stent

13. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. IVD Reagents Classification 13 Class Risk Device Examples I Low or No personal/public health risk Culture medium, Tissue and cell dye or stain, support gel, agar II Moderate individual and/or low public health risk Helicobacter phylori( H. pylori), Proteins, Bilirubin, Creatinine(Cr) III High individual and/or moderate public health risk Toxoplasma, Cytomegalovirus(CMV) IV High individual risk and high public health risk Human immunodeficiency Virus(HIV), Human helatitis C Virus(HCV)

14. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Medical Device Registration Process Overview 14 Apply & Approve (Within 10 Days) Class 1 Announced (From MFDS) Equivalent Product MFDS Regional Office Equivalent Product & Improved Product New Product MFDS Head Quarter Technical Review Technical Review (Include Clinical Investigation) Class 2 Third-party Review Organization Class 3 Class 4 Web Registration System http://emed.mfds.go.kr Apply Apply & Approve (Within 10 Days) Apply & Approve (Within 80 Days) Apply & Approved (Within 65 Days) Apply & Approve (Within 80 Days) Issue Notice

15. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Criteria for Determining the Device Type for Class 2 15 No Yes Equivalent with Performance or Test Standards or IFU? Is it Non- active Device? Yes Yes No Equivalent with Intended use and Principle? Improved Product Compare with Approved Device Equivalent with Low materials? No Equivalent Product No Yes New Product ① ② ③ ④ ⑤

16. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Documentation Requirements by Device Type for Class 2 16 Apply for Registration 1.Comparing Chart for Equivalent 2.Performance Data(included in the Test Reports) 3. Test Reports 4. Background of Development 5. Clinical Evaluation 5. Post-market information Equivalent Product Type Improved Product Type New Product Type Applicant 1.Comparing Chart for Equivalent 2.Test Reports

17. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Required Data Process 1 2 3 Required Test Records 5 6 7 4-a 4-b 4-c 4-d 4-e 4-f 4-g Equiv alent Chart Intend ed Use Princi ple of Opera tion Electri cal Radiat ion EMC Bioco mpatib ility Perfor mance Mecha nical Chemi cal Stabilit y Clinica l Evalu ation Backg round of Devel opme nt Post- Marke t Inform ation New Different Intended Use ○ ○ X ○ △ ○ X ○ X X ○ ○ ○ Different Principle of Operation ○ X ○ ○ △ ○ X ○ X X ○ ○ ○ Different Low Material ○ X X X X X X X X X X X X Improve Different Performance ○ X X X X X X ○ X X X X X Different Test Standards ○ X X ○ △ ○ X X X X X X X Different Instruction for Use ○ X X X X X X X X X △ ○ ○ Equivalent ○ X X X X X X X X X X X X

18. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Technical Documentation 18 No Medical Devices IVD Reagents 1 Product name, classification, model name 2 Shape, structure, dimension, color Color, properties, material property 3 Raw material, component, amounts, composition 4 Manufacturing process 5 Intended use Intended use(Analysis device, specimen, principle of measurement, quantitative/qualitative method) 6 Performance Performance(Sensitivity, Specificity, Precision, Accuracy, Cross-reactivity, and etc.) 7 Operating procedure & method, precautions, packing units 8 Storage conditions and stability duration 9 Test standard 10 Labeling

19. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Comparing Chart Form 19 No Items Approved Product Applied Product Equivalent 1 Classification 2 Product Name(Model) 3 Manufacturer (Distributor) Name 4 Manufacturer & Location 5 Registration No. 6 Intended Use. Yes □ No □ 7 Principle of Operation Yes □ No □ 8 Low Material or Critical Component Yes □ No □ 9 Performance Yes □ No □ 10 Test Standards Yes □ No □ 11 Instruction for Use Yes □ No □ Date (Sign)

20. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Test Reports Acceptance 20 a. Medical Instruments or dental Materials. • Test Report from test laboratories accredited by MFDS(before KFDA) is acceptable same as electrical safety. • GLP test data issued by an authorized GLP laboratory under GLP of the Organization(in case of biological safety) b. Electrically or mechanically-driven devices. • Test Report from test laboratories accredited by MFDS(before KFDA) is acceptable same as electrical safety. • CB Test Report and KORAS Test Report(in case of electrical safety) c. Performance Test Report(Common) • Test Report from test laboratories accredited by MFDS(before KFDA) is acceptable same as electrical safety. • Test Report written by manufacturer can be acceptable under quality management system.

21. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. KGMP Certified Company Status KGMP is mandatory requirement since 2007.05.30 in Korea KGMP Regulatory Requirements are based on ISO 13485 21 11 157 440 1,312 1,460 1,637 1,838 1,983 10 124 312 1,159 1,261 1,385 1,453 1,568 21 281 752 2,471 2,721 3,022 3,291 3,551 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 2004년 2005년 2006년 2007년 2008년 2009년 2010년 2011년 제조 수입 합계 Manufacturer Importer Total

22. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Regulatory Changes in KGMP 22 Until April 7, 2012 KGMP is Mandatory to All Class 1 Devices KGIP is Mandatory to Abroad Manufacturing Site (For Importing Company) 39 Product Categories for KGMP Apply the Complimentary Audit for Non-conformance Result Since April 8, 2012 KGMP is excepted for Class 1 Devices (Except 66 Product Items) KGMP is Mandatory to Abroad Manufacturing Site (For Importing Company) 25 Product Categories for KGMP Summit the Corrective Action Records for Non- conformance Result

23. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. KGMP Audit Types 23 • New & the first case • Construction of KGMP System Initial Audit • Add New Product Category • Construction of KGMP System for New Product Category Additional Audit • Manufacturing Site Transfer • Construction and Changing of KGMP System for Manufacturing Site Transfer Changing Audit • Every 3 Year / At least 1 time • Until 90 days before expire date Regular Audit

25. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Medical Device License Validity 25 License When you apply Current Designations Validity Product License: Manufacturing Approval or Import Approval For each product code 2,059 classifications Permanent Quality System Certification: KGMP Certification for Manufacturer For each of 25 device categories 25 categories 3 years Device Business License For each of the five business types 5 Business Types Permanent

28. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Introduction of the Summary Technical Documentation(STED) The regulation for STED has been revised on May 8, 2013 Benefit on STED: Fast Track Technical Review by MFDS Technical Guidance for STED will be published by MFDS until Sep. 2013 28

29. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Introduction of IEC 60601-1(third edition) with amendments Transition Data: • June 01, 2014: Class 3 & 4 • June 01, 2015: Class 2 • June 01, 2016: Class 1 29

30. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Revised "Regulations on Classification and Grades" • 94 new products are added under "cell manipulating kit for medical use". • Definitions of 108 products including “heater system” have been changed. • The Class of “a dental color measuring device” was down-classified into Class 1 from Class 2. • 67 commercial names including “warm bath equipment” are edited out. • These changes are effective as of the date of notification. 30

31. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Revising the Medical Device Software Guidance IEC 60601-1, Clause 14 & IEC 62304 Requirements ISO 14971 Risk Management IT-Network, Mobile Wireless, Medical Informatics, U-Healthcare STED 31

32. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Identifying Product Items required Clinical Investigation Data MFDS will notice the product items which shall be required the clinical investigation data. This regulation is similar with US PMA products identification. It’s just researching stage by MFDS. 32

34. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Number of Medical Device Business Entities Business Entity Year 2008 2009 2010 2011 2012 Manufacturer 1964 2031 2168 2245 2550 Importer 1571 1609 1626 1662 1898 Total 3535 3640 3794 3907 4448 34

35. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Number of Product Approval & Notification Registration Type Year 2008 2009 2010 2011 2012 Notification 3437 3631 4341 3585 3959 Approval 2224 2429 2666 2899 4013 Total 5661 6060 7007 6484 7972 35

36. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. 2012 Medical Device Market Overview in Korea 36 1,132 1,190 1,454 1,673 1,967 2,123 1,879 2,266 2,521 2,601 -991 -689 -811 -848 -634 9.7 5.1 22.2 15 3.17 -1.4 -11.5 20.6 11.3 17.55 -15 -10 -5 0 5 10 15 20 25 30 -1500 -1000 -500 0 500 1000 1500 2000 2500 3000 2008 2009 2010 2011 2012 Export(million$) Import(million$) Trade balance(A-B) Rate of export(%) Rate of import(%)

37. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Exporting Product Items (From Korea to Abroad) 37 23.13% 5.21% 4.91% 4.83% 4.36% (Unit : 1,000 $) Ranking Product Item Amount % 1 Ultrasound imaging system 454,824 23.13 2 Soft contact lens 102,433 5.21 3 Dental implant 96,573 4.91 4 Sight corrective ophthalmiclens 94,917 4.83 5 IVD strip for high throughput 85,684 4.36 6 Heating pad system 81,087 4.12 7 Probe for medical use 74,715 3.80 8 PACS/Software 57,394 2.92 9 Digital diagnostic X-ray system 53,618 2.73 10 Combinational stimulator for medical use 51,556 2.62

38. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Importing Product Items (From Abroad to Korea) 38 3.98% 3.84% 3.55% 2.70% 2.44% (Unit : 1,000 $) Ranking Product Item Amount % 1 Stent 103,453 3.98 2 Soft contact lens 99,977 3.84 3 MRI 92,356 3.55 4 CT system 70,329 2.70 5 Knee prosthesis 62,365 2.40 6 Dialyser 60,941 2.34 7 Sight corrective ophthalmiclens 60,268 2.32 8 Probe for medical use 53,581 2.06 9 Intravascular catheter 49,440 1.90 10 Ultrasound imaging system 43,059 1.66

39. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Exporting Company (From Korea to Abroad) 10.71% 9.64% 3.65% 3.15% 2.56% Ranking Exporting Company Amount % 1 Samsung Medison Co., Ltd. http://www.samsungmedison.co.kr 210,715 10.71 2 GE Healthcare Ultrasound Korea http://www.gehealthcare.com/krko/uskorea/index.html 189,639 9.64 3 Nuga Medical Co., Ltd. http://www.nugamedical.com 71,732 3.65 4 Siemens Ultrasound Korea PoHang Office http://www.siemens.co.kr/healthcare 62,039 3.15 5 Vatech http://www.vatech.co.kr 50,331 2.56 6 Siemens Ultrasound Korea http://www.siemens.co.kr/healthcare 47,318 2.41 7 Ceragem Co., Ltd. http://www.ceragem.co.kr 46,766 2.38 8 i-Sens, Inc. Wonju Office http://www.i-sens.co.kr 44,087 2.24 9 Daemyung Optical http://www.dmo.co.kr 38,890 1.98 10 Osstem Implant http://en.osstem.com 34,499 1.75 (Unit : 1,000 $) 39

40. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Importing Company (From Abroad to Korea) 6.24% 4.81% 3.57% 3.10% 3.07% (Unit : 1,000 $) Ranking Importing Company Amount % 1 Siemens Ltd. http://www.siemens.com/answers/kr/ko/ 162,181 6.24 2 Johnson & Johnson Medical Korea http://www.jnjmed.co.kr 125,053 4.81 3 Medtronic, Inc. http://www.medtronic.co.kr 92,735 3.57 4 GE Healthcare Korea http://www3.gehealthcare.co.kr/ko-KR 80,605 3.10 5 Johnson & Johnson Korea Ltd. http://www.jnj-korea.co.kr 79,725 3.07 6 Covidien Korea http://www.covidien.com/kr/pages.aspx 74,361 2.86 7 Philips http://www.philips.co.kr 63,629 2.45 8 Stryker Korea http://www.stryker.com/kr/index.htm 61,196 2.35 9 Abbott Korea http://www.abbott.co.kr 56,825 2.18 10 Roche http://www.roche-diagnostics.co.kr/Pages/default.aspx 52,678 2.03 40

41. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Exporting Country (From Korea to Abroad) United States $ 346,673 17.63% Germany $ 208,467 10.60% China $ 183,131 9.31% Japan $ 346,673 17.63% $ 175.088 8.90% Russia $ 346,673 17.63% $ 159,600 8.12% Unit : 1000$ 41

42. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Importing Country (From Abroad to Korea) United States $ 1,171,751 45.05% Germany $ 378,123 14.54% Japan $ 336,597 12.94% China $ 346,673 17.63% $ 130,248 5.01% Unit : 1000$ Swiss $ 346,673 17.63% $ 115,178 4.43% 42

43. Chapter 4 Regulatory Framework of Medical Device in Korea Recent & Upcoming Regulatory Changes 2012 Medical Device Market in Korea Useful Links UL One-stop Services 43

44. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Useful Links Ministry of Food and Drug Safety, http://www.mfds.go.kr/eng/index.do Medical Device Safety Bureau in MFDS, http://www.mfds.go.kr/medicaldevice/index.do MFDS Official News for Medical Device, http://www.mfds.go.kr/medicaldevice/index.do?nMenuCode=92 MFDS Technical Documents Sample for Medical Device, http://www.mfds.go.kr/medicaldevice/index.do?nMenuCode=23 MFDS Technical Guidance for Medical Device, http://www.mfds.go.kr/medicaldevice/index.do?nMenuCode=24 MFDS KGMP Certified Company, http://www.mfds.go.kr/medicaldevice/index.do?nMenuCode=55 MFDS e-Submission System, http://emed.mfds.go.kr 44

45. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. Useful Links MFDS On-line Searching System(Company, Product, Intended use, Licensed No., etc.), http://emed.mfds.go.kr/kfda2 Medical Device Information & Technology Assistance Center, http://www.mditac.or.kr Korea Medical Devices Industrial Cooperative Association, http://www.medinet.or.kr Korea Medical Devices Industry Association, http://www.kmdia.or.kr 45

47. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. UL One-stop Services: Overview 47 On-Line Training Service by UL Quality, Compliance and Learning ISO 13485 / ISO 9001 Quality Management Systems & FDA QSR & MFDS KGMP ISO 14971 Risk Management Early Engagement IEC 60601-1 Electrical Safety / EMC IEC 60601-1 Notified Body / Certification Usability Engineering & Testing IEC 62366 / IEC 60601-1-6 IEC 62304 Software Validation Basic Research Define Requirements New Product Idea R & D Prototype Preclinical Bio-comp Clinical Trials Final Device Regulatory Submission Commercial Launch Advisory Services for Global Regulatory Requirements: Technical Documentation & Submission (FDA, CE MDD, MFDS, CFDA, TFDA, etc.) Biocompatibility Testing (ISO 10993) Mechanical & Functional Testing Manufacturing Process Validation(e.g. Cleaning) Microbiology and Sterilization Validation Package Validation, Shelf Life & Transport Validation (ISO 11607-1, -2) Reprocessing Validation (ISO 17664)

48. © 2013 UL LLC All rights reserved. May not be copied or distributed without permission. UL One-stop Services: Advisory Services for MFDS(Regulatory Requirements in Korea) Business Growth with UL Korea Market Research Product Registration KGMP Compliance License Management by UL Sub- contractor 48

49. THANK YOU. Contact Information: Medical.Inquiry@ul.com MinYong Choi (Seoul, Korea) +82.2.2009.9366 MinYong.Choi@ul.com

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