The Indian government has introduced key regulatory reforms in the medical device sector to promote Ease of Doing Business (EoDB), simplify compliance requirements and facilitate timely access to advanced and innovative medical technologies in the country.
The reforms are part of the Medical Devices (Second Amendment) Rules, 2026, which further amend the Medical Devices Rules, 2017. The amendments cover outsourced sterilization, testing fees and clinical investigation requirements for certain medical devices.
Under the amended provisions of Rule 44, manufacturers that outsource sterilization to another facility holding a valid licence under the Medical Devices Rules, 2017, will no longer be required to obtain a separate loan licence for the sterilisation activity.
The amended rules require the licence number of the sterilisation facility to be displayed on the label of the medical device. The number is to be preceded by the words “Sterilization Sites Manufacturing License Number” or the prescribed abbreviations. Compliance with this labelling requirement will become mandatory six months from the date of notification.
The amended provision is expected to reduce regulatory compliance requirements, documentation, approval timelines and associated costs for manufacturers availing specialized sterilization facilities.
The amendment also introduces a Ninth Schedule to the Medical Devices Rules, 2017, prescribing uniform fees for testing medical devices through Medical Device Testing Laboratories.
The standardized fee structure is aimed at bringing greater transparency and predictability to testing charges, reducing variations between laboratories and minimising potential disputes between laboratories and manufacturers or importers.
In another significant reform, Rule 63 of the Medical Devices Rules, 2017 has been amended to include the European Union (EU) among recognized stringent regulatory jurisdictions for the waiver of clinical investigation requirements for certain medical devices without predicate devices.
The provision already recognizes the United States, United Kingdom, Australia, Canada and Japan. The addition of the European Union is expected to facilitate faster access in India to eligible medical devices that have already received approval in the EU, while reducing regulatory burden and timelines for importers and manufacturers.
The government said the reforms are intended to simplify regulatory processes, reduce compliance costs, enhance transparency and predictability, and support the timely availability of innovative medical devices in the country.
The amendments also seek to strengthen international regulatory convergence while ensuring the highest standards of quality, safety and performance of medical devices.
The Medical Devices (Second Amendment) Rules, 2026 were notified following consideration of objections and suggestions received on the draft rules published in the Gazette of India on April 10, 2026. The amended rules come into force from the date of their final publication in the Official Gazette, unless otherwise specified.
The Official Gazette notification may be accessed through this link:https://egazette.gov.in/WriteReadData/2026/275637.pdf
