| item |
Time length |
Topic |
Speaker |
| Introduction Session (Online Course) |
| 1 |
N/A |
Introductory Remarks |
Dr. Shih-Chung Chen
Minister, Ministry of Health and Welfare (MOHW)
|
| 5 minutes |
Opening Remarks |
Dr. Shou-Mei Wu
Director General, Taiwan Food and Drug Administration (TFDA), MOHW
|
| 10 minutes |
Roadmap and Core Curriculum of Medical Device PWA |
APEC LSIF RHSC MD PWA Co-Champion:
Mr. Yuda Maeda
Coordinator, Office of International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan |
| 10 minutes |
CoE Training Program |
Ms. Cheng-Ning Wu,
Senior Technical Specialist, Division of Medical Devices and Cosmetics, TFDA, MOHW
|
| Medical Device Session (Online Course) |
| 2 |
40 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: MD Session
Product: Soft Contact Lens |
Dr. Jai-Yen Chen
Senior Reviewer,
Division of Medical Devices,
Center for Drug Evaluation (CDE) |
| In Vitro Diagnostic Medical Device Session (Online Course) |
| 3 |
40 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: IVD Session
Product: Pregnancy Rapid Test |
Dr. Te-Hsuen Chen
Senior Reviewer,
Division of Medical Devices and Cosmetics,
TFDA, MOHW |
| Clinical Evaluation Session (Online Course) |
| 4 |
40 minutes |
- Clinical Investigation (IMDRF/MDCE WG/N57FINAL:2019)
- Clinical Evaluation (IMDRF/MDCE WG/N56FINAL:2019)
- Clinical Evidence (IMDRF/MDCE WG/N55FINAL:2019)
|
Dr. Mami Ho
Senior Scientist for Clinical Medicine,
Medical Device Unit, Office of Medical Devices I, PMDA, Japan |
| Current harmonization status of pre-market regulation in APEC member economies (Online Course) |
| 5 |
10 minutes/each |
The sharing of current harmonization status of pre-market regulation in APEC member economies will be pre-recorded. Regulators who participate in the workshop will be invited to pre-record their presentation. |
Representatives from regulatory authorities of each participating member economy |