In this In-house course, gain practical advice on how regulations are being applied to enable you to maximise on this rapidly growing market.
Now that the European Medical Device market is well established, the next growth area is Asia-Pacific. China, together with other countries in this region have all implemented, or are in the process of implementing, their own medical device regulations. This seminar will provide a comprehensive overview of the medical device regulations and developments in China together with other newly regulated markets such as India, Hong Kong and Singapore. Practical guidance on how to comply with the requirements and gain access to these growing markets will be given.
Discover how these requirements are being interpreted and applied and how to maximise on this rapidly growing market.
Delegates are invited to send their specific questions to Management Forum prior to the event to ensure these are addresed at the seminar. Please click here to email your question
Benefits in Attending:
09.00 Registration and coffee
09.30 Course starts
Overview by ChairmanOverview of Medical Device Markets in Asia
Update on the Asia Harmonization Working Party (AHWP) & ASEAN
New Medical Device Regulations in China
Current Medical Device Clinical Trial Requirements in China
Medical Device Law (PMDL) in Japan
17.00 Course finishes
09.00 Course starts
Review of Day 1
Newly Regulated Markets: Korea and Taiwan*
Newly Regulated Markets: Hong Kong
Newly Regulated Markets: Malaysia and Singapore
Newly Regulated Markets: Indonesia and Thailand
Adverse Event Reporting Systems in Asia
Delegates Questions and Answers Session
15.45 Course finishes