Tuesday, 21 October Jang Yong Choi

Transcription

1 Tuesday, 21 October 2014 Jang Yong Choi

2 Contents Status of Medical Device Industry in Korea MFDS Organization and Responsibilities Medical Device Regulation Overview Medical Device Regulation Updates

3 I. Status of Medical Device Industry in Korea

4 Medical Device Market in Korea (US $ Mn) CAGR 5.2% 6,000 5,000 4,000 size of Medical Device Market in Korea 4, , , ,532.5 Market Volume (US $ Mn) 5, ,000 2,000 1, * 11 th market in the world The World Medical Markets Fact Book 2013, Espicom

5 Medical Device Market in Korea (USD MN) 1,543 2,513 1,780 2,831 2,855 2,880 2,478 2, The World Medical Markets Fact Book 2013, Espicom Exports Imports

6 Medical Device Business Entities Number of Device Business Entities 5,000 4,000 3,000 2,000 1,000 (year) Manufacturer 2,031 2,168 2,245 2,550 2,711 Importer 1,609 1,626 1,662 1,898 2,027 Total 3,640 3,794 3,907 4,448 4,738 Product Approval No. of Product approval and notification 12,000 10,000 8,000 6,000 4,000 2,000 - (year) Notification 3,631 4,341 3,585 3,959 5,362 Approval 2,429 2,666 2,899 4,013 5,817 Total 6,060 7,007 6,484 7,972 11,179

7 II. MFDS Organization and Responsibilities

8 Ministry of Food and Drug Safety (MFDS) [former KFDA] March 22, 2013 KFDA was promoted to the Ministry of Food and Drug Safety(MFDS) Headquartered in O-Song Seoul O-Song

9 Organization of MFDS Total : 1,760 persons

10 Organization of MDS Bureau Medical Device Safety Bureau NFIDSE Medical Device Evaluation Department Review technical documents, (Class 3&4, IVD Reagents) Medical device Policy division Medical device Management division Medical device Quality division High-tech medical devices division Cardiovascular devices division Six Branch Offices(Medical Product Safety Division) (Seoul, Busan, Gyeongin, Daegu, Gwangju, Daejeon) - Class 2 MD Approvals - GMP Inspection for domestic manufacturing Sites and overseas sites for class 2 imported MD) - Post-market surveillance Orthopedic & Restorative devices division Dental & Gastroenterology devices division In vitro diagnostic device T/F

11 Other Related Organizations Subsidiary Organization Medical Device Information & Technology Assistance Center (MDITAC) Legal entity established by Medical Device Act Supports and provide information regarding clinical investigations, standards, safety, training, etc. (established June, 2012) Collaborating Third-party Organization Medical device Testing Laboratories Medical device QMS Audit Institutions Technical Document Review Agency Medical device Clinical Trial Centers Korea Medical Device Industry Association Test labs for medical devices (14 labs) Quality Management System(GMP) audit & issue certificate with MFDS (4 Institutes) Review of Technical Documents on Class 2 devices (6 Institutes) Hospitals accredited by MFDS for Medical device clinical trials (total 132) Industry association approved by MFDS Advertisement review, Performance reports, Customs prediction report, Representatives of Medical Device Industry

12 III. Medical Device Regulation Overview

13 Medical Device Regulations

14 Structure of MFDS Medical Device Regulations Medical Device Act (MDA) Enforcement Decree of MDA Enforcement Regulations of MDA MFDS Notifications of MDA - Notifications for detailed requirements supporting Act and Ministerial Regulations MFDS Guidelines and example documents on specific requirements

15 Definition of Medical Devices 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. - Articles used for the purpose of diagnosis, cure, alleviation, treatment, or prevention of illness; - Articles used for the purpose of diagnosis, cure or alleviation of or compensation for an injury or disability; - Articles used for the purpose of test, replacement, or modification of the structure or functions [of the body]; or - Articles used for the purpose of control of conception

16 Classification of Medical Devices Risk Based regulation : Classification of medical devices 4 classes based on potential risk to human health and purpose of use Harmonized with GHTF/IMDRF rules 2,206 items are designated by current Ministerial Notification

17 Overview of Medical Device Regulations Based on life span of a medical device Conception Development Manufacture Package Labeling Adverting Sale Use Disposal Manufacturer/ Importer Pre-Market Device Business Licenses (Manufacturing, Importing, Repairing, Distributing, Rental Business) Product Notification/Approval - Class I / Class II, III, IV(STED) (MFDS, KS, ISO, IEC, Standards) - Clinical Investigation Plan Approval (GCP, ICH-ISO 14155) QMS requirements(iso13485) Labeling Requirements Vendor User Manufacturer/ Importer Post-Market QMS Requirements Labeling requirements Review of advertisement Tracking and control Adverse event & safety alert reporting Re-evaluation Re-examination Recall & removal Inspections and audits

18 Overview of Medical Device Regulations

19 IV. Regulation Updates

20 Submission of Clinical Investigation data To Clarify MD which require to submit Clinical Investigation Data MD designated by the Minister : Clinical Investigation data is required - Minister designates the list of MD for Clinical Data submission - The list developed by the Working Group composed of the Industry, Academia, the 3 rd Review party and MFDS as of one year after the promulgation of the MDA Amendment

21 The IVD reagent Regulatory System IVD regulated medical devices and pharmaceuticals - IVDD : a medical device - Reagents : medical devices or pharmaceutical products Some of IVD reagents belong to pharmaceuticals All IVD reagents to be regulated as medical devices As of Six months after the promulgation of the MDA Amendment

22 Regulations on limitation to notification and approval of MD Recent discussion on controversial chemicals Regulations on limitation to notification and approval of raw material and medical devices -Mercury or asbestos-containing medical devices

23 International harmonization on STED STED are required for Class 4 (except IVD reagent) - enforced as of Jan. 1 - optional for other Classes Application Summary of TD Accompanying documents Application STED Accompanying documents STED : Summary Technical Documentation for demonstrating conformity to the safety and performance of medical devices : proposed by GHTF(IMDRF) including design verification, risk analysis & manufacturing process regarding safety and performance

24 Approval & QMS Inspection Process <Current> QMS Certification before distribution 1 Product Approval Application product approval Application for QMS conformity Conformity Distribution OR 2 Product Approval Application QMS Conformity Assessment Application Conformity Distribution

25 Approval & QMS Inspection Process QMS Certification before approval Approval Application Includes QMS Conformity Assessment Application Conformity Distribution as of six months after the promulgation of the MDA Amendment

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