Graduate Certificate in Medical Devices Regulatory Affairs

Programme Structure

The MDRA programme commences in September of each year and is comprised of four modules offered over a period of 12 months, with each module lasting approximately 12 weeks

Each module’s contents will cover two major Regulatory Affair themes, drawing from the latest development in global Medical Device Regulations. The fourth module serves as a Capstone Project in which students form group to provide solutions to real-life Regulatory Affairs challenges faced by current Regulatory Professionals.

The programme is comprised of full-day face-to-face weekend seminars and weekday tutorials. The distinctive features of this program are:

  1. Intensive weekend seminars by experts from the regulation of medical device industry: Experts from Regulatory Affairs Professional Association (RAPro) Singapore will be invited to give invited lectures and interact with students. Such extensive face-to-face and one-to-one interaction with regulatory experts from the industry will promote the learning as well as addressing individual questions and concerns. Many in-class activities will tie together key concepts taught throughout the course and allow students to demonstrate what they have learned.
  2. Tutorials: These are intended to build upon what the students learned during the seminar and independent/group research and will cover more complex content and applied concepts. As with the weekly tutorials, the format may vary, but the coverage will be deeper and more applied in nature. They will typically last for about 3 hours.

Modes of teaching/learning:

  1. Classroom Lectures (recordings provided)
  2. Individual/Group learning and research
  3. Individual and group presentations
  4. Case studies
  5. Capstone projects and reports

Note that faculty members may also utilize webinars and live chats as they deem necessary. Each module may have a graded term paper and/or presentations and a final examination.

The maximum candidature period is 3 years.