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Workshop Agenda
Short Agenda Full Agenda
Time Day 1: 8/26 (Tue.) Day 2: 8/27 (Wed.) Day 3: 8/28 (Thu.)
Morning Registration
Opening Remarks
PWA Introduction
CoE Introduction 		Lecture #3: Review of Essential Principles of Medical Device Safety & Performance and Principles of Conformity Assessment Group Practice:

MD Case Study
(1) Case Study Intro
(2) Group Discussion
(3) Group Presentation 		Lecture #5:
Clinical Evaluation
Lecture #1:
Current Harmonization Status of Pre-and Post-Market Regulation in Each Economy 		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 #4: Adverse Event Reporting

Group Practice:
IMDRF Terminologies for Medical Device Adverse Event
(1) Group Discussion
(2) Group Presentation 		Manufacturing Site Visit
(optional only for regulators)
Icebreaker Activities
Lecture #2:
Medical Device and IVD Definition and Classification + Group Practice
Evening Welcome Reception
Time Topic Speaker 
09:00 – 09:30 Registration  
09:30 – 09:45 Opening Remarks TFDA:
TBD
Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), Chinese Taipei

MD/GRM PWA Co-Champion:
TBD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan  
09:45 – 10:00 Group Photo  
10:00 – 10:10 Roadmap and Core Curriculum of MD PWA TBD
PMDA, Japan
10:10 – 10:20 Roadmap and Core Curriculum of GRM PWA Speaker (TBD)
10:20 – 10:40 Coffee Break  
10:40 – 10:50 Introduction of TFDA MD CoE Training Program TBD
Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
10:50 – 12:10 Lecture #1: 
Current Harmonization Status of Pre- and Post-Market Regulation in Each Economy 		20 min per economy    
12:10 – 13:30 Lunch  
13:30 – 14:50 Lecture #1: 
Current Harmonization Status of Pre- and Post-Market Regulation in Each Economy 		20 min per economy
14:50 – 15:10 Coffee Break  
15:10 – 15:30 Lecture #1: 
Current Harmonization Status of Pre- and Post-Market Regulation in Each Economy
(Q&A) 		Representatives from each economy
15:30 – 15:40 Break  
15:40 – 16:10 Icebreaker Activities Moderator
16:10 – 17:00 Lecture #2: Medical Device Definition and Classification
  • Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ (GHTF/SG1/N071:2012)
  • Principles of Medical Device Classification (GHTF/SG1/N77:2012)
  • Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (IMDRF/IVD WG/N64FINAL:2021) G roup Practice
 Dr. Sheng-Hui Liao
Senior Engineer, Office of Medical Device Evaluation, Center for Measurement Standards, ITRI, Chinese Taipei  
17:30 – 19:30 Welcome Reception  
*Day 1, Lecture #1 will be open to the public.
Time Topic Speaker 
09:00 – 09:30 Registration  
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)
 Mr. Naoki Morooka
Senior Manager, Quality Assurance Dept., Medical Systems Division, Shimadzu Corporation, Japan
10:00 – 12:00 Group Practice: MD Case Study (1 case)
Case Study Introduction (10 min)
Group Discussion (50 min)
Coffee Break (15 min)
Group Presentation (30 min)
Q&A (15 min) 		TBD
Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
12:00 – 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:2025 Updated Annexes)
 TBD
TDRF, Chinese Taipei
14:30 – 14:50 Coffee 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) 		TBD
TDRF, Chinese Taipei
Time Topic Speaker 
09:00 – 09:40 Registration  
09:40 – 10:40 Lecture #5: Clinical Evaluation
  • 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, CDE, Chinese Taipei
10:40 – 11:00 Expectations from the Workshop and Next Steps
  • TFDA (3 mins)
  • APEC RHSC MD PWA Co-Champion (3 mins)
  • APEC RHSC MD PWA Sub-Champions (3 mins each)
  • Members of the program committee or participants (2 mins each)
 TFDA:
TBD
TFDA, MOHW, Chinese Taipei

MD PWA Co-Champion:
TBD
PMDA, Japan
11:00 – 11:30 Coffee Break  
11:30 – 11:50 Certificate Award Ceremony TBD
TFDA, MOHW, Chinese Taipei
11:50 – 12:00 Closing Remarks TBD
TFDA, MOHW, Chinese Taipei
12:00 – 12:10 Group Photo  
12:10 – 13:00 Lunch  
13:00 – 16:00 Manufacturing Site Visit Regulators Only
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