Thailand Moves To New, More Harmonized Regulatory System
This article was originally published in Clinica
The medical device regulatory system in Thailand is in the middle of being updated to bring it more into line with international practices and particularly in line with other countries in the Association of Southeast Asian Nations (ASEAN).
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ASEAN Medtech Update: Thai Device Law Amended; Vietnam Moots Another Delay; Indonesian Reg System Updated
This month's Asian Medtech Associations' Regulatory Networking discussions focused on amended Thai medical device regulations, more concerns over Vietnam's already-deferred, dedicated medtech legislation, and regulatory news updates from Indonesia. There was also a further take on compliance with the EU MDR, seen from an EU manufacturer's viewpoint. This Asia Networking series is hosted by Medtech Insight and sponsored by the Asia Regulatory and Quality Consultancy (ARQon), and the Asia Regulatory Professionals Association (ARPA).
Those marketing products covered under the EU’s MDR and IVD Regulations have plenty of reading this month to help them prepare. More details have also emerged about the UK’s regulatory future.
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?