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Workshop Agenda Short Agenda (in-person) Short Agenda (virtual) Full Agenda
Program Overview (In-Person Participation)
Time Day 1: 8/26 (Wed.) Day 2: 8/27 (Thu.) Day 3: 8/28 (Fri.)
Morning Registration
  • Opening Remarks
  • PWA Introduction
  • Special Keynote: An Overview of Managing and Conducting the Review for Drug-Device Combination Products (optional, not endorsed as APEC CoE topic)
  • CoE Introduction
  • Lecture #1: Current Harmonization Status of Pre-and Post-Market Regulations in Each Economy
  • Icebreaker Activities
  • Lecture #3: Review of Essential Principles of Medical Device Safety & Performance and Principles of Conformity Assessment
  • Group Practice:
    MD Case Study
    1. Introduction
    2. Group Discussion
    3. Group Presentation
    4. Q&A
  • Lecture #5: Clinical Evaluation
  • Expectations from the Workshop and Next Steps
  • Certificate Award Ceremony
  • Closing Remarks
Noon Lunch
Afternoon
  • Lecture #1: Current Harmonization Status of Pre-and Post-Market Regulation in Each Economy (continued)
  • Lecture #2-1: MDSAP Introduction
  • Lecture #2-2: ISO 13485:2016 - Overview and Practical Implementation in Medical Device Quality Management + QA
  • Lecture #4: Adverse Event Reporting
  • Group Practice:
    IMDRF Terminologies for Medical Device Adverse Event
    1. Group Discussion
    2. Group Presentation
    3. Q&A
  • Manufacturing Site Visit (optional – only for regulators)
Evening Welcome Reception
Certificate Requirements (In-Person Participation)
● Full attendance from Day 1 to Day 3
● Completion of the questionnaire
Program Overview (Virtual Participation)
Time Day 1: 8/26 (Wed.) Day 2: 8/27 (Thu.) Day 3: 8/28 (Fri.)
Morning Registration
  • Opening Remarks
  • PWA Introduction
  • Special Keynote: An Overview of Managing and Conducting the Review for Drug-Device Combination Products (optional, not endorsed as APEC CoE topic)
  • CoE Introduction
  • Lecture #1: Current Harmonization Status of Pre-and Post-Market Regulations in Each Economy
  • Icebreaker Activities
  • Lecture #3: Review of Essential Principles of Medical Device Safety & Performance and Principles of Conformity Assessment
  • Group Practice:
    MD Case Study
    1. Introduction
    2. Group Discussion
    3. Group Presentation
    4. Q&A
  • Lecture #5: Clinical Evaluation
  • Expectations from the Workshop and Next Steps
  • Certificate Award Ceremony
  • Closing Remarks
Noon Lunch
Afternoon
  • Lecture #1: Current Harmonization Status of Pre-and Post-Market Regulation in Each Economy (continued)
  • Lecture #2-1: MDSAP Introduction
  • Lecture #2-2: ISO 13485:2016 - Overview and Practical Implementation in Medical Device Quality Management + QA
  • Lecture #4: Adverse Event Reporting
  • Group Practice:
    IMDRF Terminologies for Medical Device Adverse Event
    1. Group Discussion
    2. Group Presentation
    3. Q&A
  • Manufacturing Site Visit (optional – only for regulators)
Evening Welcome Reception *Sessions marked in blue are required for virtual attendees to obtain the certificate of participation.
Certificate Requirements (Virtual Participation)
● Attendance of lectures 1-5 (live streaming)
● Completion of the questionnaire
Full Agenda
Time Topic Speaker 
08:40 – 09:10 Registration (meeting room 1001)
09:10 – 09:25 Opening Remarks
  • Speaker (TBD)
    Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), Chinese Taipei
  • MD/GRM PWA Co-Champion: Speaker (TBD)
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • GRM PWA Co-Organizer: Speaker (TBD)
    APAC Leader
09:25 – 09:35 Group Photo
09:35 – 09:50 Roadmap and Core Curriculum of GRM/MD PWA
  • MD PWA: Speaker (TBD)
    PMDA, Japan
  • GRM PWA: Speaker (TBD)
    PMDA, Japan
09:50 – 10:40 Special Keynote: An Overview of Managing and Conducting the Review for Drug-Device Combination Products
(not endorsed as APEC MD CoE topic) 		Speaker (TBD)
10:40 – 10:50 Break
10:50 – 11:00 Introduction of TFDA MD CoE Training Program Mr. Hsiu-Te Lin
Section Chief, Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
11:00 – 12:20 Lecture #1:
Current Harmonization Status of Pre- and Post-Market Regulation in Each Economy
(Economy #1-4) 		20 min per economy
12:20 – 13:30 Lunch
13:30 – 15:10 Lecture #1:
Current Harmonization Status of Pre- and Post-Market Regulation in Each Economy (continued)
(Economy #5-9)		 20 min per economy
15:10 – 15:40 Break
15:40 – 16:00 Lecture #1:
Current Harmonization Status of Pre- and Post-Market Regulation in Each Economy
(Q&A)		 Representatives from each economy
16:00 – 16:20 Break (move to closed-door meeting room 1002) Moderator
16:20 – 16:50 Lecture #2-1: MDSAP Introduction
  • MDSAP Training Modules: Introduction to MDSAP
 Speaker (TBD)
PMDA, Japan
16:50 – 17:30 Lecture #2-2: ISO13485:2016 Overview and Practical Implementation in Medical Device Quality Management + QA
  • ISO13485: 2016 Medical devices -- Quality management systems -- Requirements for Regulatory Purposes
 Mr. Naoki Morooka
Senior Manager, Quality Assurance Dept., Medical Systems Division, Shimadzu Corporation, Japan
17:30 – 17:40 Day 1 Questionnaire
17:40 – 18:00 Break (move to Welcome Reception, B1F)
18:00 – 20:00 Welcome Reception
*Day 1, Opening, PWA Introduction, Special Keynote, and Lecture #1 will be open to the public.
Time Topic Speaker 
08:30 – 09:00 Registration (meeting room 1002)
09:00 – 09:30 Icebreaker Activities Moderator
09:30 – 10:00 Lecture #3: Review of Essential Principles of Medical Device Safety & Performance and Principles of Conformity Assessment
  • Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N47FINAL:2024 (Edition 2))
  • Principles of Conformity Assessment for Medical Devices (GHTF/SG1/N78:2012)
 Dr. Pei-Chia Chan
Reviewer, Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
10:00 – 10:10 Break
10:10 – 11:50
  • Group Practice: MD Case Study (1 case)
  • Case Study Introduction (10 min)
  • Group Discussion (50 min)
  • Group Presentation (30 min)
  • Q&A (10 min)
 Dr. Tai-Long Chen
Senior Reviewer, Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
11:50 – 13:30 Lunch
13:30 – 14:30 Lecture #4: Adverse Event Reporting
  • Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices (GHTF/SG2/N54R8:2006)
  • IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (IMDRF/AE WG/N43FINAL:2020 (Edition 4) and IMDRF/AE WG/N43FINAL:2026 Updated Annexes)
 Ms. Yu-Hsuan Yang
Specialist, Taiwan Drug Relief Foundation (TDRF), Chinese Taipei
14:30 – 14:50 Break
14:50 – 16:00
  • Group Practice: IMDRF Terminologies for Medical Device Adverse Event
  • Group Discussion (30 min)
  • Group Presentation (30 min)
  • Q&A (10 min)
 Ms. Yu-Hsuan Yang
Taiwan Drug Relief Foundation (TDRF), Chinese Taipei
16:00 – 16:10 Day 2 Questionnaire
Time Topic Speaker 
08:30 – 09:00 Registration (meeting room 1002)
09:00 – 10:10 Lecture #5: Clinical Evaluation + QA
  • Clinical Investigation (IMDRF/MDCE WG/N57FINAL: 2019)
  • Clinical Evaluation (IMDRF/MDCE WG/N56FINAL:2019)
  • Clinical Evidence (IMDRF/MDCE WG/N55FINAL:2019)
 Dr. Kevin Wei-I Lee
Clinical Reviewer, Division of Medical Devices, Center for Drug Evaluation (CDE), Chinese Taipei
10:10 – 10:20 Day 3 Questionnaire
10:20 – 10:40 Expectations from the Workshop and Next Steps
  • TFDA (3 min)
  • APEC RHSC MD PWA Co-Champion (3 min)
  • APEC RHSC MD PWA Sub-Champions (3 min each)
  • Members of the program committee or participants (2 min each)
  • Ms. Ellen Ying-Hua Chen
    Deputy Director, Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
  • MD PWA Co-Champion: Speaker (TBD)
    PMDA, Japan
  • MD PWA Sub-Champion: Mr. Naoki Morooka
    Vice Division Chairman, Japan Medical Imaging and Radiological Systems Industries Association (JIRA), Japan
10:40 – 11:00 Break (move to Ceremony meeting room 1001)
11:00 – 11:50 Certificate Award Ceremony Speaker (TBD)
TFDA, MOHW, Chinese Taipei
11:50 – 12:00 Closing Remarks/Group Photo
12:00 – 13:30 Lunch
13:30 – 16:00 Manufacturing Site Visit (TBD) Regulators Only
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