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Informist, Monday, Aug. 24, 2026

NEW DELHI – The government has proposed amendaments to Medical Devices Rules 2017 to promote the ease of doing business, simplify regulatory processes, enhance transparency, and facilitate timely access to advanced medical technologies in the country, the Ministry of Health and Family Welfare said in a release Monday. 

Under the amended provisions, manufacturers outsourcing product 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 outsourced sterilization activity, the ministry said. This will reduce duplication, administrative burden, compliance costs, and associated timelines, particularly for manufacturers that do not have in-house sterilization facilities, the ministry said. 

"The amended provision also provides a six-month transition period for implementation of the new labelling requirement. This will allow manufacturers adequate time to make necessary changes to their labelling, packaging and related processes before the provision comes into effect," the ministry said.

The reform seeks to strike a balance between regulatory oversight and ease of doing business by simplifying the licensing framework while retaining an essential traceability mechanism for outsourced sterilization, according to the ministry. The measure is expected to provide greater operational flexibility to manufacturers, facilitate faster and more efficient manufacturing processes, and support the growth and competitiveness of India's medical devices industry, the ministry said. 

The government has also amended Rule 63 of the Medical Devices Rules, 2017 to include the European Union among the recognized stringent regulatory jurisdictions for waiver of clinical investigation requirements for medical devices without predicate devices, the release said. 

The provision currently recognizes the US, the UK, Australia, Canada, and Japan, the ministry said. "With the inclusion of the European Union, eligible medical devices that have already been approved in the EU will be able to benefit from the waiver provisions, facilitating faster patient access to advanced medical technologies in India."

The amendment is also expected to reduce the regulatory burden and associated timelines for importers and manufacturers while strengthening international regulatory convergence in the medical device sector, according to the ministry.  End

Reported by Astha Oriel

Edited by Pankaj Aher

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