Description: Despite the fact that the AMDD has now been ratified in all ASEAN countries, regulations and requirements still vary by country, level of risk, specific product claims and intended use. Depending on the classification of the medical device, there are a variety of submissions that may be required by medical device regulatory agencies. This session will describe the best approach for medical device manufacturers to achieving compliance while having maximum control over their business in Southeast Asia.
Learning Objectives:
elaborate a comprehensive business strategy for Medical Device/IVD approval in ASEAN
understand the latest regulation changes as implemented by Vietnam and Philippines authorities
better understand the role and responsibilities of a Local Authorized Representative in Southeast Asia
.jpg "Lena Cordie-Bancroft photo")
.jpg "Yingying Liu, M.Sc. photo")