Medical Device Regulation in ASEAN and Asia-Pacific(Synchronous e-learning)
About This Course
"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. 1. To gain an understanding of ASEAN countries Device Regulation like Singapore, Malaysia, Thailand etc
2. To gain an understanding of AP countries Device Regulation like China, Australia, Japan, South Korea, Taiwan etc
3. To learn to develop regulatory strategy in these different countries
4. Be able to work in a team
5. Be conversant in individual and group presentation and report writing
"
What You'll Learn
Entry Requirements
The Graduate Certificate will be open to those with a relevant bachelor’s degree or its equivalent. Candidates with relevant qualifications and related working experience may also apply for the program. Each application will be reviewed by a Board of Admissions.