India Can Do More To Align New Medtech Regulations With Global Norms, Says Industry
India will finally get a device-specific regulatory framework when new rules formed by the government come into force next year. While the medtech industry has welcomed this long-awaited development, it hopes that its outstanding concerns will be addressed before the rules come into play.
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India’s industry association claims that some of the products on the regulator’s new draft list classifying over 700 medical devices and IVDs have been categorized incorrectly. The list is expected to be finalized at least three months before new medical device rules come into effect in January 2018.
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.
As part of the Indian government's three-pronged strategy to bring the entire medtech sector under regulatory control, it has proposed new rules and finalized quality management system standards for medical devices and in vitro diagnostics.