About Workshop
The 2025 APEC Medical Devices Regulatory Science Center of Excellence Workshop focuses on training and education related to pre-market submission and post-market surveillance of medical devices. Through this workshop, it is expected that all member economies will gain a greater understanding of international best practices, learn to implement harmonized approaches, and seek to facilitate regulatory convergence for medical devices, and this in turn may benefit the health and well-being of people in the Asia-Pacific region.
Venue
TBD
Target Audience
- Regulators from APEC member economies and non-member economies
- Industry managers (or equivalent position) who have experience in product application submission
- Academic researchers or industry managers who have experience in product development
Program Overview
- Online and self-paced learning to develop knowledge base in advance of training
- 3-day training designed with lectures, group discussions, and case studies
- Manufacturing site visit for regulators
Recommendations for Accommodation
TBD
Limited funding available for regulators from travel-eligible economies (Chile, China, Indonesia, Malaysia, Mexico, Papua New Guinea, Philippines, Peru, Russia, Thailand, Vietnam)
Contact Information
- ITRI Secretariat at TFDAMDCOE@gmail.com
CoE Hosting Institution
Taiwan Food and Drug Administration
Co-Organizer
The APEC Regulatory Harmonization Steering Committee
Program Committee
Pharmaceuticals and Medical Devices Agency
Japan Medical Imaging and Radiological Systems Industries
Advanced Medical Technology Association
Taiwan Medical and Biotech Industry Association
Taiwan Advanced Medical Technology Association
Center for Drug Evaluation, Taiwan
Industrial Technology Research Institute
