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Workshop Agenda
1st Part：
August 29 to September 7		 2nd Part：
September 8 to September 11
Online Course 1: Introduction Session
  • Opening Remarks
  • Roadmap and Core Curriculum of Medical Device PWA
  • CoE Training Program
2nd Videoconference
Case Study of Conformity Assessment: Medical Device Session
Online Course 2
  • Basic Scheme of Conformity Assessment Procedure and Classification for Medical Devices (GHTF/SG1/N77&N78)
  • Summary of Essential Principles for Medical Devices (IMDRF/GRRP WG/N47)
  • Introduction of Case Study: Medical Device Session
3rd Videoconference
Case Study of Conformity Assessment: IVD Session
Online Course 3
  • Basic Scheme of Conformity Assessment Procedure and Classification for In Vitro Diagnostic (IVD) Medical Devices (GHTF/SG1/N045&N46)
  • Summary of Essential Principles for In Vitro Diagnostic (IVD) Medical Devices (IMDRF/GRRP WG/N47)
  • Introduction of Case Study: IVD Session
4th Videoconference
Presentation of Case Studies, Q&A, and Closing
1st Videoconference
  • Q&A for Online Courses
  • Q&A for the current harmonization status of pre-market regulation in each APEC member economy
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Online Course /
Videoconference		 Time Length Course Speaker/Moderator/Panelist
Online course session (open for access on August 29)
Online course 1 10 minutes Opening Remarks
Dr. Shih-Chung Chen
Minister, Ministry of Health and Welfare (MOHW)
Dr. Shou-Mei Wu
Director General, Taiwan Food and Drug Administration (TFDA), MOHW
10 minutes Roadmap and Core Curriculum of Medical Device PWA Dr. Yoshimasa Yokoyama
Planning and Coordination Officer, Office of International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
10 minutes CoE Training Program Dr. Chao-Yi Wang
Researcher, Division of Medical Devices and Cosmetics, TFDA, MOHW
Online course 2 25 minutes
  • Basic Scheme of Conformity Assessment Procedure and Classification for Medical Devices (GHTF/SG1/N77&N78)
  • Summary of Essential Principles for Medical Devices (IMDRF/GRRP WG/N47)
 Dr. Takeshi Endo
Principal Officer, Division of Standards for Medical Devices, Office of Standards and Compliance for Medical Device, PMDA, Japan
  • Introduction of Case Study: Medical Device (MD) Session
 Dr. Yoshimasa Yokoyama
Planning and Coordination Officer, Office of International Cooperation, PMDA, Japan
Online course 3 25 minutes
  • Basic Scheme of Conformity Assessment Procedure and Classification for In Vitro Diagnostic (IVD) Medical Devices (GHTF/SG1/N045&N46)
  • Summary of Essential Principles for In Vitro Diagnostic (IVD) Medical Devices (IMDRF/GRRP WG/N47)
  • Introduction of Case Study: In Vitro Diagnostics (IVD) Session
Ms. Cheng-Ning Wu
Section Chief, Division of Medical Devices and Cosmetics, TFDA, MOHW
Videoconference session
1st videoconference 06:00-08:00
GMT
September 4,
2020
  • Q&A for online courses
  • Q&A for the current harmonization status of pre-market regulation in each APEC member economy
  • Moderator: Grace Huang
  • Q&A panelists for online courses: Dr. Yoshimasa Yokoyama, Ms. Cheng-Ning Wu, Dr. Ted Chang, Dr. Jos van Vroonhoven, Dr. Peter Linders
  • Q&A panelists for videoconference: Representatives of regulatory authority from each member economy
Online Course /
Videoconference		 Time Length Course Speaker/Moderator/Facilitator/Panelist
Videoconference session
2nd videoconference 06:00-07:30
GMT
September 8		 Case Study: Medical Device (MD) Session
  • Introduction of Product (20 minutes)
 Group A
Discussion (70 minutes)
  • Moderator: Grace Huang
  • Speaker: Dr. Yoshimasa Yokoyama Planning and Coordination Officer, Office of International Cooperation, PMDA, Japan
  • Group A Facilitators: Cerline Tsai and Serena Lin
  • Group B Facilitators: Alan Tang and Grace Huang
Group B
Discussion (70 minutes )
3rd videoconference 01:00-02:30
GMT
September 9		 Case Study: In Vitro Diagnostics (IVD) Session
  • Introduction of Product (20 minutes)
 Group C
Discussion (70 minutes )
  • Moderator: Grace Huan
  • Speaker: Ms. Cheng-Ning Wu, Section Chief, Division of Medical Devices and Cosmetics, TFDA, MOHW
  • Group C Facilitators: Sandra Chu and Grace Huang
  • Group D Facilitators: Shu-Wei Hsu, Nicole Kuo and Serena Lin
Group D Discussion (70 minutes )
4th videoconference 01:00-03:00
GMT
September 11
  • MD Case Study Presentation (10 minutes/Group and 10 minutes for answer explanation)
  • IVD Case Study Presentation (10 minutes/Group and 10 minutes for answer explanation)
  • Q&A (20 minutes)
  • Expectations from the Workshop (25 minutes)
    • APEC LSIF RHSC MD PWA Co-Champion (5 minutes)
    • APEC LSIF RHSC MD PWA Sub-Champions (5 minutes each)
    • CoE Program Committee (5 minutes)
    • TFDA (5 minutes)
  • Closing (5 minutes)
  • Moderator: Grace Huang
  • Q&A panelists for online courses: Dr. Yoshimasa Yokoyama, Dr. Takeshi Endo, Ms. Cheng-Ning Wu
  • Speakers
    • Representative of APEC LSIF RHSC MD PWA Co-Champion: Dr. Yoshimasa Yokoyama
    • Representatives of APEC LSIF RHSC MD PWA Sub-Champions: Ms. Janet Trunzo (Advamed), Mr. Naoki Morooka (JIRA)
    • Members of CoE Program Committee: Ms. Danelle Miller
    • TFDA: Dr. Chao-Yi Wang, Researcher, Division of Medical Devices and Cosmetics, TFDA, MOHW
  • Closing
    • TFDA: Ms. Pei-Weng Tu, Director, Division of Medical Devices and Cosmetics, TFDA, MOHW
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