2025.12.04_ G.S.R. 883(E)_Draft Notification for amendment in Medical Device Rules, 2017

The draft rules propose targeted amendments to the Medical Devices Rules, 2017 and invite objections/suggestions from stakeholders within 30 days from the date Gazette copies are made available to the public. Proposed changes include updates to Rules 44 and 45 to allow “Registration number/Reg. No.” for Class A (Non‑Sterile and Non‑Measuring) medical devices in specified labelling/documentation references. The draft removes the words “AND NOTIFIED BODY” from the Chapter IX heading and introduces a new compliance requirement under Rule 85 by adding sub-rule (xi), mandating submission of test/evaluation results in newly inserted Form MD‑44. It also updates Form MD‑11 references and signature/seal provisions, adds structured sampling detail tables to Forms MD‑36, MD‑37 and MD‑38, and clarifies Fifth Schedule applicability to cover manufacturers of medical devices including IVDs.