New Delhi: Through a recent Gazette notification, the Ministry of Health and Family Welfare (Department of Health and Family Welfare) has issued a draft notification proposing amendments to the Medical Device Rules, 2017, introducing new qualification requirements for Inspectors and Government Analysts engaged in medical device regulation and quality testing.

The draft, published in the Gazette of India (G.S.R. 748(E)) on October 10, 2025, was issued under Sections 12(1) and 33(1) of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board (DTAB).

The proposed amendments, titled the Medical Devices (Amendment) Rules, 2024, invite objections and suggestions from the public within 30 days from the date copies of the Gazette are made availa

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