Asia Reg Roundup: Malaysia, Vietnam & India Speed Ahead In 2017
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.
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China is making additions to its medtech regulatory system, and Southeast Asian nations are making progress towards ratifying the regional Medical Device Directive. Meanwhile, cybersecurity, priority reviews and the Medical Device Single Audit Program are demanding attention regionally and globally, as ARQon consultant May Ng and Asia Regulatory Professional Association (ARPA) secretary Jack Wong report in this Asian regulatory update.
All eyes are on Vietnam, which is on the threshold of a new regulatory system for medical devices. But the smaller regional markets like Bangladesh and Hong Kong are giving medtechs much to think about too, as Asia Regulatory Professional Association (ARPA) secretary Jack Wong and ARQon consultant May Ng observe in this latest Asian regulatory roundup.
'Perfect Storm' Arrives: Clock Ticking For Device Firms To Conform To ISO 13485, MDSAP, EU & ASEAN Regs
Device manufacturers that haven't begun conforming to various ongoing international regulatory changes are behind the 8-ball and risk noncompliance, industry insider Kim Trautman says.