Korea Medical Device Regulatory Requirements Update

Transcription

1 Korea Medical Device Regulatory Requirements Update April 28 th, 2015 Prepared by MinYong Choi UL Korea, Ltd. UL and the UL logo are trademarks of UL LLC 2015

2 MinYong Choi Engineering Leader Medical Regulatory Advisory Services Life & Health Sciences Business Unit UL Korea, Ltd. 26 th Floor, Gangnam Finance Center, 152, Teheran-Ro, Gangnam-Gu, Seoul Korea T: , F: E: Background: 2012~Present UL Korea 2011~2012 DNV, ISO Auditor & CE MDD Assessor, DNV Business Assurance 2005~2011 KFDA (now MFDS) Medical Device Evaluation Department, Technical Reviewer Master's Degree in Software Engineering & Bachelor s Degree in Computer Engineering Additional Experiences: ISO TC 215 (Health Informatics) Technical Committee, JWG7 Member KFDA Medical Device Software Guidance in 2007

3 Agenda Part 1: Overall Medical Device Regulation in Korea Part 2: KGMP Regulation (Quality Management System Regulation) 3

4 Part 1: Overall Medical Device Regulation in Korea 4

5 MFDS o MFDS is Ministry of Food and Drug Safety, a government department for Drug, Food, & Medical Device in South Korea. o This is former KFDA, Korean Food and Drug Administration. o MFDS headquarters has been moved from Seoul to O-Song city(the Bio-Health Techno-polis) in November o MFDS has 6 regional office in Korea. Seoul O-Song 5

6 MFDS Website Regulations & Guidances Download 6

7 Medical Device Organization in MFDS Ministry of Food and Drug Safety Medical Device Safety Bureau Medical Device Policy Division Medical Device Management Division Medical Device Safety Evaluation Division 6 Regional MFDS National Institute of Food and Drug Safety Evaluation Seoul Regional FDA Busan Regional FDA GyeongIn Regional FDA DaeGu Regional FDA GwangJu Regional FDA DaeJeon 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 Medical Device Evaluation Department High-tech Medical Devices Division Cardiovascular Devices Division Orthopedic and Restorative Devices Division Dental and Gastroenterology Devices Division IVD Devices Division 7

8 Structure of Medical Device Regulation in Korea Act Medical Device Act (MDA) Presidential Decree Enforcement Decree of MDA MFDS Ministerial Regulations Enforcement Regulations of MDA MFDS Minister Notifications MFDS Guidelines MFDS Notifications of MDA Notifications for detailed requirements supporting Act and Ministerial Regulations Total 21 specific regulations notified 8

9 Medical Device Definition in Korea Medical Device Act, Article 2(Definitions) For the purpose of this Act, the term "medical device" means any instrument, machine, contrivance, material or similar article that is used on human beings or animals either alone or in combination with other devices and that falls under any of the following Items provided below. However, drugs or quasi-drugs under the Pharmaceutical Affairs Act or, among the disabled-assistive-devices under Article 65 of the Act for Welfare of the Disabled, artificial limbs and orthotics shall be excluded: 1. Devices used for the purpose of diagnosis, cure, alleviation, treatment, or prevention of illness; 2. Devices used for the purpose of diagnosis, cure or alleviation of or compensation for an injury or disability; 3. Devices used for the purpose of test, replacement, or modification of the structure or functions [of the body]; or 4. Devices used for the purpose of control of conception(pregnancy). 9

10 Medical Device Business Licenses Medical Device Manufacturing Business Medical Device Importing Business Approved by MFDS Medical Device Repairing Business Notify to MFDS Waiver of Repairing Business License If a person repair their own medical device, that has been approved the medical device product license to a person by MFDS. Medical Device Selling Business Medical Device Renting Business Notify to Regional Administrative Office 10

11 Medical Device Licenses Holder USA Korea Medical Device Importing Biz License Medical Device Export Medical Device License 11

12 Medical Device License Unique Medical Device License Number Medical Device Importing Biz License Number Medical Device Classification Information & Model Name 12

13 Medical Device Class Class 4 Class 3 Class 2 Class 1 Risks 13

14 Medical Device Classification Classification Criteria o Class 1: Medical device contains No potential hazard o Class 2: Medical device contains Low potential hazard o Class 3: Medical device contains Moderate potential hazard o Class 4: Medical device contains High potential hazard Potential Hazard Criteria o Duration of body contacting o Invasive degree o Delivery of drug or energy to patient o Biological effect to patient 14

15 IVD Reagent Classification Classification Criteria o o o o Class 1: Containing low potential hazard influence on personal & public health Class 2: Containing moderate potential hazard influence on personal & containing low potential hazard influence on public health Class 3: Containing high potential hazard influence on personal & containing moderate potential hazard influence on public health Class 4: Containing high potential hazard influence on personal & public health Potential Hazard Criteria o Intended use & precautions for use o User s clinical experience (Clinical expert or public user) o The importance of diagnostic information o The effect of diagnostic test result on personal or public health 15

16 Medical Device Classification Structure A C Medical Device B D Identifier Device Type Examples A Medical Instruments A , Radiation Treatment Planning Software, Class 2 B Medical Supplies B , Suture, Linen, Class 3 C Dental Materials C , Alloy, Amalgam, Class 2 D Reagents for In vitro Diagnostics(IVD Reagents) D , IVD reagents for blood test, Class 2 16

17 Medical Device Classification: Official Identification Process in MFDS 17

18 Class 4 required Clinical Investigation Data MFDS will require the clinical investigation data from some of Class IV medical device items (total 63 items) from Jan 01, These clinical investigation have to be performed using the actual medical device manufactured by the applicant. 18

19 Medical Device Registration Process Class 1 Web Registration System Equivalent Product by MFDS Apply & Approve (Within 10 Days) Class 2 General Product Apply Issue Notice Third-party Review Organization MFDS Regional Office Apply & Approve (Within 10 Days) New Product Apply & Approve (Within 80 Days) Technical Review Apply & Approved (Within 65 Days) Class 3 Class 4 Technical Review (Clinical Investigation Data) Apply & Approve (Within 80 Days) MFDS Head Quarter 19

20 E-Registration System 20

21 Technical Documentation Editor Technical Documents Attached Documents 21

22 Technical Documentation 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 22

23 IEC rd Edition Transition Plan 23

24 Test Reports Acceptance Criteria a. Biological test report MFDS accredited test reports: Issued by MFDS accredited test laboratories GLP test reports: Issued by OECD GLP test laboratories b. Electrical or Mechanical test report (220VAC, 60Hz) MFDS accredited test reports: Issued by MFDS accredited test laboratories CB test reports: Issued by CBTL c. Performance test report MFDS accredited test reports: Issued by MFDS accredited test laboratories Internal test reports: Issued by manufacturer under KGMP 24

25 Medical Mobile App Guidance MFDA has issued a regulatory guidance for Medical Mobile App in Dec According to this guidance, Healthcare Mobile App is classified as Medical Device. 25

26 New Software Requirements The new software requirements will include the documentation requirements defined in IEC The new software requirements will require the summary information and evidences about software life-cycle process outputs. 26

27 Part 2: KGMP Regulation 27

28 Korea Good Manufacturing Practice KGMP is mandatory requirement since in Korea KGMP Regulatory Requirements are based on ISO Class 1 has been exempted since Sep 16, 2013 Class 2, 3 & 4 must have on-site audit There are 26 KGMP Categories 28

29 Who have to apply KGMP? Domestic Manufactured Medical Device KGMP Imported Medical Device Clinical Trial Medical Device 29

30 KGMP Audit Type Initial Audit New Application Additional Audit Add New Product Category Changing Audit Manufacturing Site Transfer Renewal Audit Every 3 Year / At least 1 time Until 90 days before expire date 30

31 KGMP Application Type On-Site Review On-Site Review with MFDS Document Review 31

32 KGMP Application Type Chart Manufacture Class Initial Additional Changing Renewal Class 2 Single Document Single Single Domestic Class 3 Joint Document Single Single Class 4 Joint Document Joint Joint Class 2 Single Document Document Single Foreign Class 3 Joint Document Document Single Class 4 Joint Document Document Joint o Single: On-Site Review by KGMP Inspection Institute o Joint: On-Site Review by KGMP Inspection Institute + MFDS o Document: Document Review 32

33 KGMP 26 Category 1/2 Case 1 Same Manufacturing Site & Same KGMP Category Case 2 Same Manufacturing Site & Different KGMP Category 33

34 KGMP 26 Category 2/2 Case 3 Manufacturing Site & Same KGMP Category 34

35 Relationship between Legal Manufacturer & Real Manufacturer Full Manufacturing Process Requesting Legal Manufacturer Real Manufacturer Medical Device Providing Normally MFDS do on-site review in Real manufacturing site. But MFDS can have on-site review in both manufacturing sites. 35

36 KGMP Application Process Apply Check Schedule Applicant KGMP Institute MFDS(Regional) Require Supplementary Actions Review Result Nonconforming Conforming Conforming Supplementary Issue KGMP NonConformity Require Re- Supplementar y Actions Re- Supplemen tary (10 day) Conforming Nonconforming 36

37 Differences between KGMP regulations & ISO requirements 1/ Control of documents Control of records Management representative Feedback 37

38 Differences between KGMP regulations & ISO requirements 2/5 ISO Control of documents KGMP 문서관리 The organization shall define the period for which at least one copy of obsolete controlled documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.4), or as specified by relevant regulatory requirements. 제조업자는효력이상실된관리문서의최소 1 부를제품의사용기한에상응하는기간동안보유하여야한다. 이기간은최소한 5 년이상이어야하며시판후 2 년이상이어야한다. Minimum 5 years & 2 years after product sales. 38

39 Differences between KGMP regulations & ISO requirements 3/5 ISO Control of records KGMP 기록관리 The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements. 제조업자는품질기록을제품의사용기한에상응하는기간동안보유하여야한다. 이기간은최소한 5 년이상이어야하며시판후 2 년이상이어야한다. Minimum 5 years & 2 years after product sales. 39

40 Differences between KGMP regulations & ISO requirements 4/5 ISO Management representative KGMP 품질책임자 Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes a)ensuring that processes needed for the quality management system are established, implemented and maintained, b)reporting to top management on the performance of the quality management system and any need for improvement (see 8.5), and c)ensuring the promotion of awareness of regulatory and customer requirements throughout the organization. The responsibility all about quality management in manufacturing site. The responsibility about the evaluation of quality management result &product release 제조업자는다른책임과무관하게다음사항을포함하는책임과권한을갖는사람을조직의관리자중에서선임하여야한다. 1) 제조소의품질관리에관한업무 2) 제조소의품질관리결과의평가및제품의출하여부결정 3) 품질경영시스템에필요한프로세스가수립되고실행되며유지됨을보장 4) 제조업자에게품질경영시스템의성과및개선의필요성에대하여보고 5) 조직전체에걸쳐법적요구사항및고객요구사항에대한인식의증진을보장 40 Additional Requirements

41 Differences between KGMP regulations & ISO requirements 5/5 ISO Feedback KGMP 피드백 If national or regional regulations require the organization to gain experience from the post-production phase, the review of this experience shall form part of the feedback system (see 8.5.1). 제품의안전성및유효성과관련된새로운자료나정보를알게된경우에는식품의약품안전처장이정하는바에따라이를보고하고필요한안전대책을강구하여야한다. Have to report to MFDS immediately. 41

42 KGMP Application Form Form #1 42

43 KGMP Certificate 43

44 Regulation Changes related to KGMP Manufacturer have to get KGMP before Medical Device Registration, Jul 29 th 2015 [Grace Period, Jan 29 th 2016] Before After Medical Device Registration KGMP Sales KGMP Medical Device Registration Sales 44

45 THANK YOU.