ABSTRACT
This chapter focuses on how to design a regulatory course to train university students in regulatory affairs. Medical device regulation comes with new framework, new principal and supportive responsibilities in Asian and European countries. The Medical Device Regulation, which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for European Medicines Agency and for national competent authorities in the assessment of certain categories of products. Students will be trained to understand the global, regional, and local medical device regulatory requirements and trends. Besides conducting lectures, students will be arranged into a small group to work on a medical device and practice preparing a medical device registration submission to a competent authority.
