The 2021 APEC 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 within APEC economies, and this in turn may benefit the health and well-being of people in the Asia-Pacific region.

• 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

The workshop will be held virtually by online courses, with the addition of website tools and resources utilized for the training exercises.

Each trainee is expected to complete 5 online courses, training exercises, and questionnaires. The requirements are:

• Completion of the total hours of all 5 online courses
• Submission of answers to training exercises, i.e., Essential Principles conformity checklists for case studies (MD/IVD)
• Completion of all questionnaires