ASEAN Medtech Update: Thai Device Law Amended; Vietnam Moots Another Delay; Indonesian Reg System Updated
Asian Medtech Associations' Regulatory Networking Series
Executive Summary
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).
You may also be interested in...
Singapore Prepares UDI System, Malaysia Seeks Regulatory Improvements And Indonesia Adjusts To Changing Environment
Medtech industry representatives from ASEANMed member economies, notably Singapore, Malaysia and Indonesia, provided regulatory updates at the February Asia Regulatory Roundtable. These roundtables are organized by the ARQon consultancy and the Asia Regulatory Professional Association (ARPA). They are sponsored by Medtech Insight.
Asian Medtech Update: Thai Device Law Latest; National Issues Aired; ASEANMed Seeks Medtech Industry Role At AMDC
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).
Industry Responds To Vietnam's Draft Decree 36, And Justifies 2020 Deadline Extension
Medtech companies' chance to comment on the final draft of amendments to Vietnam's medical device regulations closed in mid-June. The Vietnam Ministry of Health released a translation of the draft to allow multinational companies and other foreign stakeholders full access to the ongoing debate on extending the deadline to the end of 2019, as proposed by industry in the latest exchanges.