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FAQs: Decoding the Medical Devices Rules, 2017

Come January 1, 2018, there will be a radical shift in the legal regime applicable to medical devices. Under the current regime only 15 medical devices are covered for regulation under the Drugs and Cosmetics Rules, 1945. A gamut of 250 medical devices is proposed to be regulated under the Medical Devices Rules, 2017, which come into force in January. This list can be further expanded by notification from time to time. Damini Bhalla and Gargi Bohra share their insights into how the new regime will shape up. Edited excerpts:

Which devices come under the ambit of the Rules?

The