India proposes perpetual licensing and uniform testing for medical devices

Subscribe to enjoy similar stories. NEW DELHI: The Centre plans to scrap expiry-based licences for medical devices and introduce perpetual approvals alongside uniform lab testing rules, according to two officials and a draft notification reviewed by Mint.

The move aims to cut compliance burdens in a sector valued at $14-15 billion and projected to double by 2030. Under the proposed changes, licences for manufacturing and importing medical devices will no longer lapse after five years but will remain valid indefinitely, provided companies pay periodic retention fees.

At the same time, all registered laboratories will be required to submit test reports in a standardized format to address long-standing inconsistencies that have complicated regulatory oversight. Together, the measures are intended to simplify compliance, lower costs and improve product safety, while making India a more attractive destination for investment in medical devices.

“To keep these licences valid, companies will simply need to deposit a retention fee (at specified intervals), eliminating the uncertainty and administrative hurdles associated with filing fresh renewal applications repeatedly," one of the officials said. The current five-year validity was introduced under the Medical Devices Rules, 2017, which came into effect on 1 January 2018; prior to that, medical devices were regulated under the broader Drugs and Cosmetics Rules, 1945, which did not have a distinct licensing structure for devices.

Industry groups have broadly welcomed the move but flagged potential complications for exporters. Rajiv Nath, forum coordinator at the Association of Indian Manufacturers of Medical Devices (AiMeD), said that while perpetual licences improve ease of