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: TFDA
- 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)
|
- 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
|