The 2022 TFDA Medical Devices Regulatory Science Center of Excellence Workshop focuses on training and education related to pre-market submission of medical devices. The concept of using essential principles to perform the conformity assessment of medical devices will be promoted. Through this workshop, it is expected that all member economies will gain a greater understanding of international best practices, learn to implement harmonized approaches, 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.

• Regulators from competent authorities
• Industry managers (or equivalent position) who have experience in product application submission
• Academic researchers or industry managers who have experience in product development

The workshop will be held virtually by online courses and videoconferences.

Each trainee is expected to complete 5 online courses and attend 3 videoconferences (including 1 videoconference on case study). The case study to attend will be assigned by CoE hosting institution. Certificates of participation will be mailed to qualified trainees that have met the following minimum requirements:

• Completion of 90% of the total hours of all 5 online courses
• Attendance of at least 2 videoconferences (including 1 on case study)