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

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

3. 1. Introduction of AHWP

4. 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
Chair of AHWP : South Korea (2015~2017) 2

5. Organization of AHWP
AHWP 3

6. 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

7. 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

8. 2. AHWP Playbook

9. 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

10. 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

11. Capacity Building Program
3. AHWP
Capacity Building Program

12. 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

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

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

15. 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 (in 2004)
Clinical trial management
- Harmonized with ISO (in 2005)
MFDS
COMMISSIONER
NOTIFICATIONS
MFDS Notification
of MDA (22 notifications) 13

16. 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

17. 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

18. 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

19. 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

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

21. 5. Upcoming Events

22. 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

23. 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

24. Thank you