Graduate Certificate in Medical Devices Regulatory Affairs

Module Descriptions

Module 3 (OTH347): Medical Device Regulation in ASEAN Countries, China and the Asia-Pacific

This course provides a comprehensive review of medical device regulation in the ASEAN countries, China and the Asia-Pacific. The emergence of harmonization in the ASEAN community will be discussed and students will see how harmonization efforts translate into regulatory requirements. Regulatory and submission strategy for the ASEAN market will be a key focus of this course with a blend of practical and applied concepts to include the review of a sample submission.

Students will also explore important background information regarding China’s society, culture and law and assess how select concepts apply to healthcare system. A thorough review of the registration procedure follows, including discussions on product classification, standards and requirements, and communication with the China Food and Drug Administration (CFDA) and provincial FDA offices. Other critical areas of discussion include postmarket requirements as well as regulations pertaining to combination products and IVDs.

The Asia Pacific region is a key focus of regulatory professionals based in Singapore and presents a unique healthcare environment with a diverse collection of medical device regulations for each country. This module will also emphasize Japan, Korea, Taiwan, and Australia— and provide a broad overview of basic regulatory processes across the product lifecycle. Similarities and differences among each system will be examined and impact on regulatory strategy will be discussed, along with the role of harmonization bodies in shaping the current regulatory environment.

Following are the topics that will be covered:

  1. Overview of Medical Devices in ASEAN Countries
  2. ASEAN Medical Device Directives (AMDD)
  3. Considerations for Developing a Regulatory Strategy for the ASEAN Countries
  4. Overview of Medical Device Regulation in China
  5. The Medical Device Lifecycle in China
  6. Developing a Regulatory Strategy for Medical Devices in China
  7. South Korea
  8. Japan
  9. Taiwan
  10. Australia