Asia Reg Roundup: Vietnam On Track Launching New System, Plus Updates From Bangladesh, Hong Kong
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.
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Stakeholders aired concern in Vietnam this summer about the amount of time available for companies to meet the new national device regulatory system's July 1 deadline for class A, lowest-risk, medical device applications. There are now worries over whether the next deadline, December 31, will be met for the higher-risk category devices, according to local experts Jack Wong and May Ng in this regional update that also includes updates from Malaysia, Bangladesh and Hong Kong.
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.
Architects of the major reform of secondary care reimbursement have asked for the input of hospitals just once, the DKG hospital federation complains. Meanwhile, many clinics are reportedly facing insolvency later this year.