Graduate Certificate in Medical Devices Regulatory Affairs

Module Descriptions

Module 4 (OTH275): Medical Device Regulatory Process Planning

In this module, the students take a prototype through a regulatory pathway in one of the regions such as EU, Asia Pacific, ASEAN and China based upon their understanding of the medical device regulatory process. Students will have both team and individual activities and deliverables for this module culminating in a simulated submission to be carried out by student teams.

The project module brings together the knowledge acquired from the earlier 3 modules i.e. Module 1, Module 2 and Module 3. This enables the students to apply the concepts learned and take a medical device prototype through a region-specific regulatory pathway. The possible regions include the USA, the EU, Asia Pacific, ASEAN countries and China.