Archive · 18 Dec 2025
India Proposes Perpetual Licensing for Medical Devices
India wants to make rules for medical devices easier.
Right now, companies have to renew their licenses every five years, but the government wants to change that.
They want licenses to last forever as long as companies pay a fee sometimes.
This will make it simpler for companies to follow the rules and sell their products.
The government also wants all labs to use the same format for testing reports, so everything is clear and consistent.
This will help make sure medical devices are safe and good quality.
Some people are happy about these changes, but others are worried about selling products outside India because other countries might not accept licenses that don't expire.
India plans to introduce perpetual licensing for medical devices, eliminating the need for five-year renewals.
Companies will need to pay periodic retention fees to keep their licenses valid.
Standardized testing and reporting formats will be introduced to ensure consistency and improve regulatory oversight.
The changes aim to simplify compliance, lower costs, and improve product safety.
Exporters have raised concerns about overseas regulators requiring certificates with defined validity periods.
- Who
- Indian government, medical device manufacturers, exporters, regulatory bodies
- What
- Proposal for perpetual licensing and uniform testing for medical devices
- When
- Draft notification reviewed, implementation timeline not specified
- Where
- India
- Why
- To cut compliance burdens, lower costs, improve product safety, and attract investment
- Sector Value
- $14-15 billion
- Projected Value by 2030
- $28-30 billion
- Exports in FY2024-25
- ₹31,120 crore ($3.7 billion)
- Export Growth (Last 6 Years)
- 88%
- FDI in Medical and Surgical Appliances (2000-2025)
- $3.91 billion (₹27,458 crore)
- PLI Scheme Investments (by Sept 2025)
- ₹2 trillion