Medical Devices (Second Amendment) Rules, 2026: New Sterilization Labelling Requirements and Testing Fees

The Ministry of Health and Family Welfare has notified the Medical Devices (Second Amendment) Rules, 2026 through G.S.R. 743(E) dated 14 August 2026. The amendment introduces a new Rule 44(p) requiring medical device manufacturers that outsource sterilization to another licensed facility to mention the sterilization site's licence number on the device label, using specified wording or abbreviations. Compliance with this labelling requirement becomes mandatory six months from the date of the notification. The amendment also introduces a Ninth Schedule prescribing fees for specified tests and evaluations, including implantation, sterility, surgical dressings, syringes and needles, surgical sutures, condoms, intrauterine devices and bacterial endotoxin testing. The prescribed testing/evaluation costs will increase automatically by 5% annually. Corresponding amendments have also been made to Rules 19 and 69 concerning applicable testing and evaluation fees.