The Ministry of Health and Family Welfare (MoHFW), Department of Health and Family Welfare, on August 14, 2026, notified the Medical Devices (Second Amendment) Rules, 2026 under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, further amending the Medical Devices Rules, 2017. The amendment follows consideration of objections and suggestions received on the draft rules published on April 10, 2026. [G.S.R. 743(E)]
A new definition of “Certificate of Registration” has been introduced, covering registration certificates granted by the State or Central Licensing Authority in Forms MD-2, MD-40 and MD-42. Further, where a medical device manufacturer outsources sterilisation to another facility holding a valid sterilisation licence, the licence number of the sterilisation site must be mentioned on the device label, preceded by specified wording such as “Sterilization sites Manufacturing License Number”, “Ster. Mfg. Lic. No.” or “S.M.L.”.
The amendment also inserts a Ninth Schedule prescribing fees for test or evaluation under Rules 19 and 69. The labelling requirement relating to the sterilisation-site licence number under clause (p) of Rule 44 will become mandatory after six months from the date of notification. The amended Rules otherwise come into force from the date of their final publication in the Official Gazette.
[G.S.R. 743(E)]
