Perpetual licensing, uniform testing for medical devices

Licences for manufacturing and importing medical devices will no longer lapse after five years

- Priyanka Sharma

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 seek to simplify compliance, cut costs and improve product safety, while making India a more attractive destination for investment in medical devices.