2023 APEC Medical Devices Regulatory Science Center of Excellence Workshop

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Workshop Agenda

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Time	Day 1 - Aug. 29 (Tue.)	Day 2 - Aug. 30 (Wed.)	Day 3 - Aug. 31 (Thu.)
Morning (3 hours)	Registration	Registration	Registration
	Introduction of Workshop Introduction of APEC Medical Device PWA Introduction of CoE	Medical Device Session Principles of Conformity Assessment for Medical Devices Essential Principles of Medical Device Safety & Performance Case Study 1: Infusion set	Optimizing Standards for Regulatory Use Q&A
	Coffee Break	Coffee Break	Coffee Break
	Current Harmonization Status of Pre-Market Regulation in Each Economy Panel Discussion (Q&A)	Group Discussion Group Presentation	Expectations from the Workshop and Next Steps Certificate Award Ceremony
Noon	Lunch	Lunch	Lunch
Afternoon (3 hours)	Icebreaker Activities	In Vitro Diagnostic Device Session Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices Essential Principles of Safety and Performance of IVD Medical Devices Case Study 2: Influenza Virus Antigen Detection Test System	(Optional – only for regulators) Manufacturing site visit
	Definition & Classification Session Medical Device & In Vitro Diagnostic Device Classification
	Coffee Break	Coffee Break
	Definition and Classification Practice	Group Discussion Group Presentation
Evening	Welcome Reception

Day 1 - Aug. 29 (Tue.)
Day 2 - Aug. 30 (Wed.)
Day 3 - Aug. 31 (Thu.)

Time	Topic	Speaker
09:00-09:30	Registration
09:30-09:40	Opening Remarks	TFDA: Dr. Shou-Mei Wu Director General, Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), Chinese Taipei APEC RHSC MD PWA Co-Champion: Dr. Kinue Nishioka Division Director, Division of Asia II, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
09:40-09:50	Group Photo
Introduction of Workshop
09:50-10:00	Roadmap and Core Curriculum of Medical Device PWA	APEC RHSC MD PWA Co-Champion: Ms. Miwa Kanematsu Principal Coordinator, Division of Asia II, Office of International Programs, PMDA, Japan
10:00-10:10	Introduction of TFDA CoE Training Program	Mr. Hsiu-Te Lin Section Chief, Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
Current Harmonization Status of Pre-Market Regulation in Each Economy
10:10-10:40	Introduction of Medical Device Registration in Each Economy	10 mins per economy
10:40-10:55	Coffee Break
10:55-11:55	Introduction of Medical Device Registration in Each Economy	10 mins per economy
11:55-12:10	Panel Discussion (Q&A)
12:10-13:30	Lunch
13:30-14:20	Icebreaker Activities	Moderator
14:20-14:40	Medical Device & In Vitro Diagnostic Device Definition & Classification Session 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)	Dr. Sheng-Hui Liao Senior Engineer, Office of Medical Device Evaluation, Center for Measurement Standards, Industrial Technology Research Institute (ITRI), Chinese Taipei
14:40-15:00	Coffee Break
15:00-16:20	Definition and Classification Practice Presentation (Q&A)	Dr. Sheng-Hui Liao Senior Engineer, Office of Medical Device Evaluation, Center for Measurement Standards, Industrial Technology Research Institute (ITRI), Chinese Taipei
18:30-20:20	Welcome Reception

*Morning sessions will be open to public

Time	Topic	Speaker/Facilitator
Medical Device Session
08:30-09:00	Registration
09:00-09:30	Medical Device Session Principles of Conformity Assessment for Medical Devices (GHTF/SG1/N78:2012) Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices(IMDRF/GRRP WG/N47FINAL:2018) Case Study 1: Infusion set	Dr. Hsi-Yi Yeh Senior Reviewer, Division of Medical Devices, Center for Drug Evaluation (CDE), Chinese Taipei
09:30-10:40	Group Discussion
10:40-11:00	Coffee Break
11:00-12:00	Group Presentation (Q&A)	Dr. Hsi-Yi Yeh Senior Reviewer, Division of Medical Devices, Center for Drug Evaluation (CDE), Chinese Taipei
12:00-13:30	Lunch
In Vitro Diagnostic Device Session
13:30-14:00	In Vitro Diagnostic Device Session Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices (GHTF/SG1/N046:2008) Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N47FINAL:2018) Case Study 2: Influenza Virus Antigen Detection Test System	Mr. Shang-Ching Lin Associate Technical Specialist, Division of Medical Devices and Cosmetics, TFDA, MOHW
14:00-15:10	Group Discussion
15:10-15:30	Coffee Break
15:30-16:30	Group Presentation (Q&A)	Mr. Shang-Ching Lin Associate Technical Specialist, Division of Medical Devices and Cosmetics, TFDA, MOHW
16:30	Adjourn

Time	Topic	Speaker/Facilitator
Optimizing Standards for Regulatory Use
08:30-09:30	Registration
09:30-10:10	Optimizing Standards for Regulatory Use (IMDRF/Standards WG/N51FINAL:2018) Q&A	Mr. Naoki Morooka Senior Manager, Quality Assurance Dept., Medical Systems Division, Shimadzu Corporation, Japan
10:10-10:25	Group Photo
10:25-10:40	Coffee Break
Expectations from the Workshop and Next Steps
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 planning committee or Participants (2 mins each)	TFDA Dr. Hwei-Fang Cheng Deputy Director General, Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), Chinese Taipei MD PWA Co-Champion Dr. Kinue Nishioka Division Director, Division of Asia II, Office of International Programs, PMDA, Japan MD PWA Sub-Champion
11:00-11:15	Certificate Award Ceremony	Dr. Hwei-Fang Cheng Deputy Director General, Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), Chinese Taipei
11:15-11:20	Closing Remarks	Dr. Hwei-Fang Cheng Deputy Director General, Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), Chinese Taipei
11:20-13:30	Lunch
13:00-17:00	Manufacturing Site Visit	Regulators only

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