Ensuring Safe and Effective Healthcare Technologies
Implementation and Enforcement of Medical Device Regulation
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Gyan Tripathi A primer on the regulation of medical devices in IndiaRegulation of medical devices in India In India, the regulation of medical devices is governed by the Drugs and Cosmetics Act, 1940 and the rules framed thereunder. Medical devices are classified as drugs under the Drugs and Cosmetics Act, 1940 and are regulated as such. As per the Drugs and Cosmetics Act, 1940, a medical device is defined as any instrument, apparatus, appliance, implant, materia… more
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