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Workshop Agenda
Short Agenda Full Agenda
Time Day 1: 8/28 (Wed.) Day 2: 8/29 (Thu.) Day 3: 8/30 (Fri.)
Morning
(3-hr)		 Registration
Introduction of Workshop:
  1. APEC MD PWA
  2. CoE
Lecture #3: Review of
  1. Essential Principles of Medical Device Safety & Performance and
  2. Principles of Conformity Assessment
Lecture #4:
Clinical Evaluation
Lecture #1:
Current Harmonization Status of Pre-Market Regulation in Each Economy
Q&A 		Group Practice #2:
IVD Case Study (1 case)
  1. Case Study Intro
  2. Group Discussion
  3. Group Presentation
Expectations from the Workshop and Next Steps
Certificate Award Ceremony
Noon Lunch
Afternoon
(3-hr)		 Icebreaker Activities Group Practice #3:
MD Case Study (2 cases)
  1. Case Study Intro
  2. Group Discussion
  3. Group Presentation
Manufacturing Site Visit
(optional – only for regulators)
Lecture #2:
Medical Device and IVD Definition and Classification
Group Practice #1:
Definition and Classification Practice
Evening Welcome Reception
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
MD PWA Co-Champion:
Ms. Miwa Kanematsu
Principal Coordinator, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
09:40 – 09:50 Group Photo
09:50 – 10:00 Roadmap and Core Curriculum of MD PWA
MD PWA Co-Champion:
Ms. Kanae Ohara
Coordinator, Office of International Programs, PMDA, Japan
10:00 – 10:10 Introduction of TFDA CoE Training Program
Mr. Ching-Wei Chang
Section Chief, Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
10:10 – 12:00 Lecture #1:
Current Harmonization Status of Pre-Market Regulation in Each Economy
Presentation (30 min)
Coffee Break (20 min)
Presentation (45 min)
Q&A (15 min)		 15 min per economy
12:00 – 13:20 Lunch
13:20 – 14:20 Icebreaker Activities Moderator
14:20 – 14:50 Lecture #2: Medical Device and IVD Definition and Classification
  1. Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ (GHTF/SG1/N071: 2012)
  2. Principles of Medical Device Classification (GHTF/SG1/N77: 2012)
  3. 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
14:50 – 15:00 Coffee Break
15:00 – 16:00 Group Practice #1:
Definition and Classification Practice (40 min)
Group Presentation (15 min)
Q&A (5 min)
Dr. Sheng-Hui Liao
Senior Engineer, Office of Medical Device Evaluation, Center for Measurement Standards, Industrial Technology Research Institute (ITRI), Chinese Taipei
17:30 – 19:30 Welcome Reception
*The morning session will be open to the public.
Time Topic Speaker/Facilitator
09:00 – 09:30 Registration
09:30 – 10:00 Lecture #3: Review of (1) Essential Principles of Medical Device Safety & Performance and (2) Principles of Conformity Assessment
  1. Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N47FINAL: 2018)
  2. Principles of Conformity Assessment for Medical Devices (GHTF/SG1/N78: 2012)
  3. Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices (GHTF/SG1/N046: 2008)
Mr. Shang-Ching Lin
Associate Researcher, Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
10:00 – 12:00 Group Practice #2: IVD Case Study
Case Study Introduction (10 min) (1 case)
Group Discussion (50 min)
Coffee Break (15 min)
Group Presentation (30 min)
Q&A (15 min)
Mr. Shang-Ching Lin
Associate Researcher, Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
12:00 – 13:30 Lunch
13:30 – 16:00 Group Practice #3: Medical Device Case Study
Case Study Introduction (15 min) (2 cases)
Group Discussion (60 min)
Coffee Break (15 min)
Group Presentation (45 min)
Q&A (15 min)
Ms. Yu-Hui Huang
Specialist, Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
Mr. You-Lin Lee
Associate Reviewer, Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
Time Topic Speaker/Facilitator
09:00 – 09:30 Registration
09:30 – 10:10 Lecture #4: Clinical Evaluation
  1. Clinical Investigation (IMDRF/MDCE WG/N57FINAL: 2019)
  2. Clinical Evaluation (IMDRF/MDCE WG/N56FINAL: 2019)
  3. Clinical Evidence (IMDRF/MDCE WG/N55FINAL: 2019)
Q&A
Dr. Daisuke Fujisawa
Principal Reviewer, Office of Medical Device II, PMDA, Japan
10:10 – 10:20 Group Photo
10:20 – 10:40 Coffee Break
10:40 – 11:00 Expectations from the Workshop and Next Steps
  1. TFDA (3 mins)
  2. APEC RHSC MD PWA Co-Champion (3 mins)
  3. APEC RHSC MD PWA Sub-Champions (3 mins each)
  4. Members of the planning committee or participants (2 mins each)
TFDA:
Dr. Chia-Hung Chien
Director, Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
MD PWA Co-Champion:
Ms. Miwa Kanematsu
Principal Coordinator, Office of International Programs, PMDA, Japan
11:00 – 11:20 Certificate Award Ceremony
Dr. Der-Yuan Wang
Deputy Director-General, TFDA, MOHW, Chinese Taipei
11:20 – 11:30 Closing Remarks
Dr. Der-Yuan Wang
Deputy Director-General, TFDA, MOHW, Chinese Taipei
11:30 – 13:00 Lunch
13:00 – 17:00 Manufacturing Site Visit Regulators Only
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