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Advancements in Regulatory Framework For Medical Device Regulations In India
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| Author:
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VENUGOPAL N, SELLA SENTHIL M, K GOWTHAMARAJAN, ARUN R
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| Abstract:
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Earlier in India, the medical device sector was largely unregulated, where medical devices was classified under drugs. From 1989, around 15 devices were regulated by CDSCO as ‘Notified Medical Devices’. Whereas now, due to new innovation and advancements in technology, the medical devices have been multi-billion dollar global industry, but lacking in the clarity for regulating them by the national health authorities. Thus, CDSCO, the regulatory authority of India has come forward in separating medical devices from drugs and providing them new regulations. As a result of it, the new “Medical Device Rules-2017” was released by the Ministry of Health & Family Welfare. The article highlights an overview of the new rules, comparison with old regulations and also addresses on few challenges and implementation bottlenecks for the success of the legislation.
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| Keyword:
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Medical Devices, India, Patenting, Pricing, Standards, Device Segments, Import, Manufacture, Perpetual license, Life cycle, Nomenclature.
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2020.SP1.089
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| Download:
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Request For Article
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