Asia Reg Roundup: Vietnam Decree, Malaysia Labels And More
Medtech companies selling into the Vietnam market need to start preparing for major regulatory changes that will be introduced in 2017 via a new decree. That is the advice of Asia Regulatory Professional Association (ARPA) secretary Jack Wong and ARQon consultant May Ng, who spoke to Medtech Insight on a range of regional Asian regulatory issues for this September update.
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The second Asian Medtech Associations Regulatory Networking discussion focused on a range of regional issues, including the latest on-the-ground news and views. Hosted by Medtech Insight, and sponsored by the Asia Regulatory and Quality Consultancy (ARQon), the Asia Regulatory Professionals Association (ARPA) and Medtronic, this session is reported in two parts, with this first part focusing on Malaysia.
Progress on ratifying the ASEAN Medical Device Directive (AMDD) continues apace, with some of the Association of Southeast Asian Nations members surging ahead. Malaysia and Vietnam, in particular, are making big efforts to build or strengthen their national regulatory systems foe devices. Also, non-ASEAN state India is taking real steps in a similar direction, say Asia Regulatory Professional Association (ARPA) secretary Jack Wong and ARQon consultant May Ng in this latest Asian regulatory update.
An end-of-year flurry of regulatory activity in the Asian medtech markets has kept industry on its toes, with initiatives in China, Taiwan and Korea, among other regions. But as Asia Regulatory Professional Association (ARPA) Secretary Jack Wong and ARQon consultant May Ng observe in this December update for Medtech Insight, governments and companies in certain markets might benefit from a little more pressure in view of the regulatory tasks they face.