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Asian Medtech Update: Thai Device Law Latest; National Issues Aired; ASEANMed Seeks Medtech Industry Role At AMDC

Asian Medtech Associations' Regulatory Networking Series

 
• By Ashley Yeo

This month's Asian Medtech Associations' regulatory networking discussions cover the current progress of the Thai medical device regulation, which must be in place before the national elections; Vietnam's efforts to introduce practical, workable device regulations; ASEANMed's aims to represent the regional industry at AMDC; and other ASEAN national updates. This series is hosted by Medtech Insight and sponsored by the Asia Regulatory Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).

Thai medical device industry association ThaiMed has been asked by Thai FDA to give feedback on the draft amendments to the Medical Device Act (BE 2551) within two months. (Also see "ASEAN Medtech Update: Thai Device Law Amended; Vietnam Moots Another Delay; Indonesian Reg System Updated" - Medtech Insight, 31 May, 2018.) Addressing the July Asian Medtech Associations' Regulatory Networking session, ThaiMed said it was being asked to comment on the application of the proposed medical device regulation for IVDs and non-IVDs, and labeling issues. The draft is not yet available in English.

The association also pointed out that Thai FDA will be using an e-submissions process in future, meaning companies perhaps no longer needing any direct contact with FDA staff. But training...

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