ABSTRACT
This chapter focuses on how to design a regulatory course to train university students in regulatory affairs. The course in regulatory affairs aims to give both factual and practical knowledge of what is regulatory requirement and how to handle future regulatory tasks. Students will be trained to understand the global, regional, and local medical device regulatory requirements and trends. Students will be able to handle regulatory tasks, including classification, risk management, International Organization for Standardization standard, product registration, and commercial materials review. 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. After all risk control measures have been implemented and verified, the manufacturer shall decide whether the overall residual risk posed by the medical device is acceptable using the criteria defined in the risk management plan.
