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Workshop Agenda
1st Part: August 26 to September 11 2nd Part: September 2 to September 8
Online Course 1: Medical Device Session
  • Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ (GHTF/SG1/N071:2012)
  • 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: Fingertip Pulse Oximeter
1st Videoconference (Sep. 2)
Current Harmonization Status of Pre-Market Regulation in Medical Devices
2nd Videoconference (Sep. 6)
IVD Case Study of Conformity Assessment: Dengue Virus Antigen Assay
Online Course 2: In Vitro Diagnostic Device Session
  • Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ (GHTF/SG1/N071:2012)
  • 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: Dengue Virus Antigen Assay
3rd Videoconference (Sep. 6)
MD Case Study of Conformity Assessment: Fingertip Pulse Oximeter
Online Course 3: Optimization Standards Session       
  • Optimizing Standards for Regulatory Use (IMDRF/Standards WG/N51 FINAL:2018)
Online Course 4: Digital Health Session
  • Trends & Challenges of AI Technology in Digital Health
4th Videoconference (Sep. 8)
Presentation of Case Studies, Q&A, and Closing
Online Course 5: Medical Device Manufacturing Video
  • Continuous Positive Airway Pressure (CPAP) Device
1st Part (August 26 to September 11)
item Time length Topic Speaker
Online Learning Session
Medical Device Session
1 30 minutes
  • Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ (GHTF/SG1/N071:2012)
  • 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: Fingertip Pulse Oximeter
Dr. Shang-Lung Dong
Reviewer, Division of Medical Devices and Cosmetics, TFDA, MOHW
In Vitro Diagnostic Medical Device Session
2 30 minutes
  • Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ (GHTF/SG1/N071:2012)
  • Basic Scheme of Conformity Assessment Procedure and Classification for In Vitro Diagnostic Medical Devices (GHTF/SG1/N45&N46)
  • Summary of Essential Principles for Medical Devices (IMDRF/GRRP WG/N47)
  • Introduction of Case Study: Dengue Virus Antigen Assay
Mr. Shang-Ching Lin
Assistant Technical Specialist, Division of Medical Devices and Cosmetics, TFDA, MOHW
Optimizing Standards Session
3 30 minutes
  • Optimizing Standards for Regulatory Use (IMDRF/Standards WG/N51 FINAL:2018)
Mr. Naoki Morooka
Senior Manager, Quality Assurance Dept., Medical Systems Division, Shimadzu Corporation, Japan
Digital Health Session
4 30 minutes
  • Trends & Challenges of AI Technology in Digital Health
Mr. Varun Veigas
Leader - Policy and Strategic Partnership, Health Policy and Patient Access Value Stream, Roche Diagnostics Asia Pacific Pte. Ltd
Medical Device Manufacturing Video
5 13 minutes
  • Continuous Positive Airway Pressure (CPAP) Device
APEX Corp.
2nd Part (September 2 to September 8)
item Time length Topic Speaker
Videoconference Session
1 09:00-11:00 TST
September 2
  • Current Harmonization Status of Pre-Market Regulation in Medical Devices
  • Opening: Dr. Shou-Mei Wu Director General, Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW)
  • Moderator: Grace Huang, Coordinator, GIS Group
  • Speakers: Representatives from each participating regulatory authority
  • Q&A for speakers
2 09:00-10:30 TST
September 6
Case Study: In Vitro Diagnostics (IVD)
Session
  • Introduction of Product (20 minutes)
  • Group A
    Discussion (70 minutes)
  • Moderator: Grace Huang
  • Speaker: Mr. Shang-Ching Lin, Assistant Technical Specialist, Division of Medical Devices and Cosmetics, TFDA, MOHW
  • Facilitators of Group A:
    • Dr. Shao Chang, Assistant Professor, Program of Biotechnology Management, National Taiwan University
    • Eli (Shuwei) Hsu, Regulatory Affairs Associate, Regulatory Affairs and Drug Development Solutions, IQVIA
    • Grace Huang, Coordinator, GIS Group
3 14:00-15:30 TST
September 6
Case Study: Medical Device (MD)
Session
  • Introduction of Product (20 minutes)
  • Group B
    Discussion (70 minutes)
  • Moderator: Grace Huang
  • Speaker: Dr. Shang-Lung Dong, Reviewer, Division of Medical Devices and Cosmetics, TFDA, MOHW
  • Facilitators of Group B:
    • Teresa Huang, GA, Market Access & RA Associate Director, TW&HK, Alcon Services AG, Taiwan Branch
    • Grace Huang, Coordinator, GIS Group
  • Facilitators of Group C:
    • Nicole Kuo, Engineer, Office of Medical Device Evaluation, ITRI
    • Serena Lin, Coordinator, GIS Group
  • Group C
    Discussion (70 minutes)
4 09:00-10:30 TST
September 8
  • Opening Remarks (5 minutes)
  • IVD Case Study Presentation (15 minutes/Group and 5 minutes for answer explanation)
  • MD Case Study Presentation (10 minutes/Group and 5 minutes for answer explanation)
  • Q&A of Online Courses (30 minutes)
  • Closing Remarks (5 minutes)
  • Moderator: Serena Lin
  • Opening:
    • Ms. Pei-Weng Tu Director, Division of Medical Devices and Cosmetics, TFDA, MOHW
  • IVD: Representative from Group A
  • MD: Representatives from Groups B&C
  • Q&A: Dr. Shang-Lung Dong, Mr. Shang-Ching Lin, Mr. Naoki Morooka, Mr. Varun Veigas
  • Closing:
    • Ms. Cheng-Ning Wu, Senior Technical Specialist, Division of Medical Devices and Cosmetics, TFDA, MOHW
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