One of the most significant changes concerns manufacturers that rely on external facilities to sterilise their products
India is moving to simplify the regulatory pathway for medical devices, with the government proposing amendments aimed at reducing compliance burdens, improving transparency and helping eligible technologies reach the Indian market faster.
The proposed changes to the Medical Devices Rules, 2017, cover three key areas: outsourced sterilisation, testing fees and the recognition of the European Union as a stringent regulatory jurisdiction for certain clinical investigation waivers.
The reforms are part of the government’s wider push to improve Ease of Doing Business in the medical device sector while supporting access to advanced and innovative healthcare technologies.
One of the most significant changes concerns manufacturers that rely on external facilities to sterilise their products.
Under the proposed amendment to Rule 44, manufacturers using outsourced sterilisation services would no longer need to obtain a separate loan licence under Rule 25, provided the sterilisation facility itself holds a valid licence under the Medical Devices Rules, 2017.
Previously, manufacturers without their own sterilisation infrastructure were required to secure a separate loan licence for sterilisation activities. Removing this additional requirement could reduce paperwork, approval timelines and associated costs.
The change could also make it easier for smaller manufacturers to access specialised sterilisation facilities without having to develop their own infrastructure.
Another major reform involves testing charges. A new Ninth Schedule has been proposed to establish uniform fees for medical device testing laboratories.
At present, variations in testing charges can create uncertainty for manufacturers and importers. A standardised fee structure is intended to make costs more predictable while reducing ambiguity and potential disputes between laboratories and industry stakeholders.
The government expects the measure to improve transparency and provide a more consistent regulatory environment across the medical device testing ecosystem.
The third amendment focuses on devices without predicate products. Rule 63 is proposed to recognise the European Union alongside existing stringent regulatory jurisdictions, including the United States, United Kingdom, Australia, Canada and Japan.
This could have a direct impact on the speed at which certain devices already approved in the EU can enter the Indian market. Eligible products could receive a waiver from clinical investigation requirements in India, reducing duplication in regulatory processes and potentially shortening approval timelines.
For medical technology companies, faster regulatory pathways can be particularly important when introducing innovative diagnostic, monitoring or treatment devices. For patients and healthcare providers, quicker access could improve the availability of technologies that have already undergone rigorous assessment in recognised jurisdictions.
However, regulatory simplification must continue to be balanced with safety and quality. Medical devices range from relatively simple products to highly sophisticated technologies that can directly affect patient outcomes. Consistent testing, licensing and oversight therefore remain essential even as administrative procedures are streamlined.
The proposed amendments reflect India’s attempt to create a regulatory framework that is both efficient and responsive to technological change. By reducing unnecessary duplication while introducing greater consistency in testing and recognising established international regulatory standards, the government is seeking to make India a more predictable market for medical technology.
If implemented, the reforms could help manufacturers bring eligible devices to Indian patients more efficiently while strengthening transparency across the sector.:::
