2026.04.10_ G.S.R. 270(E)_Draft Notification to amend certain provisions under Medical Devices Rules, 2017 EU

The Ministry of Health and Family Welfare has published draft amendment rules to the Medical Devices Rules, 2017 via G.S.R. 270(E). As detailed on pages 2–5 of the Gazette, the proposal introduces significant regulatory updates including a new definition for “Certificate of Registration” under Rule 3, aligning it with Forms MD-2, MD-40, and MD-42. A key compliance requirement mandates that manufacturers outsourcing sterilization must include the sterilization site’s license number on product labels. Additionally, a new Ninth Schedule has been introduced specifying standardized fees for various testing and evaluation procedures such as sterility testing, implantation testing, and endotoxin testing, with provisions for a 5% annual fee increase. Amendments also integrate these fees into Rules 19 and 69. These changes aim to enhance transparency, traceability, and consistency in regulatory processes.