AHWP Activities for Regulatory Capacity Building Dr. Jeong-Rim Lee AHWP TC Co-chair Korea MFDS Sep. 2017

Contents Introduction of AHWP AHWP Playbook AHWP Capacity Building Program The Experience of Korea on Regulatory Harmonization & Capacity Building Upcoming Events

1. Introduction of AHWP

AHWP Member Economies 2 30 member economies as of September, 2017 Asia : 18 Middle East : 8 Africa : 3 South America : 1 Abu Dhabi Brunei Cambodia Chile China Chinese Taipei Hong Kong India Indonesia Korea Laos Malaysia Myanmar Philippines Jordan Saudi Arabia Singapore South Africa Thailand Vietnam Yemen Pakistan State of Kuwait Mongolia Kazakhstan Kingdom of Bahrain Sultanate of Oman United Arab Emirates Zimbabwe Tanzania 30 member economies as of September, 2017 6 new countries joined AHWP as member economies during 2015-2017 Chair of AHWP : South Korea (2015~2017) 2

Organization of AHWP AHWP 3

in Dec 4-8th in New Delhi, India AHWP Annual Meeting 2015 2016 2017 20th AHWP Annual Meeting Nov 2-6th in Bangkok 241 participants, 28 countries 11 main themes and 6 panel discussions with 36 speakers 2 new member economies 21st AHWP Annual Meeting Nov 21-25th in Cebu 300 participants, 40 countries 12 main themes and 5 panel discussions with 66 speakers 4 new member economies 1 new liaison TC Leaders Meeting March 2-3rd in Hong Kong Development of guidance documents with AHWP leaders, advisors and WG members International conference Upcoming Events 22nd AHWP Annual Meeting will be held in Dec 4-8th in New Delhi, India TC Leaders Meeting Mar 19-20th in Singapore TC Leaders Meeting April 27-29th in Seoul 4

A new official website for easier access & better communication 20th Anniversary of AHWP Celebration Ceremony Certificate of appreciation for all of 30 member economies & 3 liaisons AHWP Website Renewal A new official website for easier access & better communication 5

2. AHWP Playbook

Introduction of Playbook Concepts Regulatory Controls Legislation & Policy Framework Phased Implementation of Regulatory Framework Contents Regulatory Requirements & Elements in the MD lifecycle Pre-market approval, QMS, Post-market surveillance Implementation plan, Manpower, Resources 7

Foundation & Application of Playbook WG1 – Pre-Market : MD WG2 – Pre-Market : IVDD WG3 – Pre-Market : SaMD WG4 – Post-Market WG5 – Clinical Evidence for Performance & Safety WG6 – QMS : Audit & Assessment WG7 – QMS : Operation & Implementation WG8 – Standards WG9 – UDI Capacity Building Training Regulatory Framework Design Phased Implementation Good Regulatory Practices Efforts to Harmonization of AHWP WGs 8

Capacity Building Program 3. AHWP Capacity Building Program

AHWP Capacity Building Program CBP Overview Kick-off in Nov 6th, 2015 in Thailand Overall budget is $50,000 USD Capacity Building Workshop in Philippines In-Country Training in Indonesia November 21-22nd, 2016 150 international regulators & industrial members Topics: cybersecurity, GMDN, product dossier for pre-market registration submission, post- market report and review July 28-29th, 2016 50 Indonesia regulators 20 experts from industry Topics: AHWP’s essential principles of safety and performance and clinical studies In-Country Training in Vietnam In-Country Training in Malaysia August 25-26th, 2016 50 Vietnam regulators & experts from industry Topics: classification of medical devices & IVDs, pre-market approval, post-market surveillance August 10th, 2017 200 international regulators & experts from industry Topics: software, information technology, post- market considerations 10

Capacity Building Workshops Indonesia, Jul. 2016 Vietnam, Aug. 2016 Philippines, Nov. 2016 Malaysia, Aug. 2017 11

4. The Experience of Korea in Regulatory Harmonization & Capacity Building

Globally Harmonized Regulations OVERALL MD REGUALTORY SYSTEM AND ITS OPERATION Medical Device Regulations Medical Device Act (MDA) Developed regulatory system by legislating Medical Device Act (2003) ACT PRESIDENTIAL DECREE Enforcement Regulations of MDA Established risk-based Medical Device Classifications : 1~4 classes, - Use of GHTF/IMDRF Rules (2003) PRESIDENTIAL DECREE MFDS MINISTERIAL REGULATIONS MFDS MINISTERIAL REGULATIONS Implementing Regulations of MDA Introduced QMS for medical device - Harmonized with ISO 13485 (in 2004) Clinical trial management - Harmonized with ISO 14155 (in 2005) MFDS COMMISSIONER NOTIFICATIONS MFDS Notification of MDA (22 notifications) 13

Overview of Korea Regulatory System Well-Balanced System to Manage Total Lifecycle of MD AE Reporting Recalls Monitoring & Tracking Post-market QMS Conformity Approval Clinical Trial Pre-market 14

Overall Medical Device Regulations Flowchart of Overall MD Regulations Regulation for QMS Management Relevant Tasks Manufacturing Class 2 to 4 Importing Class 2 to 4 Pre- Market QMS Conformity Business License Item Approval Certification Notification (class 1) Certification- (Class 2 to 4) Distribution Selling-Renting-Repairing Conformity Assessment Business License for Manufacturing and Importing Medical Devices Notifications of Item(immediately notified at the submission of application) ※ Exemption of QMS audit Approval for Clinical Investigation Plan (If needed) Technical Documents Review Class 2 Class 3&4 Post- Post-market Safety Management Selling & Renting Business Notification Repair Business Notification Inspection of QMS Compliance Recall Management of Labeling and Advertising Tracking of High Risk Medical Devices Adverse Event Reporting Administrative Disposition and Punishment (penalty, fine) 15

Classification of IVD in Korea Examples Class 4 HIV, HBV, HCV, HTLV, ABO, Rh(D) test for Blood Screening,… High Risk in both Indiv. & Public Health Class 3 High risk infection agents(SDT, Influe, Malaria), Cancer marker, Heart disease marker,… High Risk in Indv. Health & Moderate Risk in Public Health Class 2 Low risk infection agents(helico bactor, c. difficile), GOT, GPT, g-protein, creatinine, pregnant test,… Moderate Risk in both Indv. & Public Health Class 1 Nucleic acid extraction, H&E, Media,… Low Risk in both Indiv. & Public Health 16

Collaboration Efforts on Development of IVD Guidance Documents AHWP WG2 Guidance Documents AHWP WG 2 More than 10 Member Economies Korea MFDS Public-Private Advisory Group Classification of IVDs In Vitro Companion Diagnostic Devices (IVD-CDx) IVD Labelling 18

Capacity Building Program in Korea Introductory Course on Pre & Post Market Control Visiting Good Manufacturing Sites Visiting Clinical Trial Centers 19

5. Upcoming Events

22th AHWP Annual Meeting Date: Dec 4th- 8th, 2017 Venue: the Grand New Delhi, India Program: AHWP annual meeting, AHWP Technical Committee meeting, Capacity building workshops, Joint workshops with liaisons, Updates of IMDRF & other international organizations 21

4th International Medical Device Communication Forum Date : May, 2018 Venue : Seoul, Korea Program : Innovative technologies and medical device regulations, Collaborative efforts on global regulatory harmonization, Presentations by IMDRF member countries & Panel discussions with industry experts 22

Thank you