Four Medical Devices brought under Regulatory Purview

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Dec 31, 2018

Four Medical Devices brought under Regulatory Purview

By way of a notification dated December 3, 2018, the Ministry of Health and Family Welfare (‘MHFW’) has brought four commonly used medical devices (i.e. nebulizers, blood pressure monitoring devices, digital thermometers and glucometers) under the purview of ‘drugs’, as defined under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 (‘DCA’), with effect from January 1, 2020. These are an addition to the pre-existing list of 23 other medical devices, already defined as ‘drugs’ under the DCA.

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