Medical device rules eased for outsourced sterilisation; EU added to stringent regulatory jurisdictions

The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, to promote ease of doing business. The amendments seek to simplify regulatory requirements, standardise testing fees and facilitate faster market access for eligible medical devices.

The Centre has eased regulatory requirements for medical device manufacturers by removing the need for a separate licence for outsourced sterilisation and expanding the list of countries and regulatory jurisdictions whose approvals can facilitate waiver of clinical investigation requirements in India, a release issued by the Ministry said on Monday (August 24, 2026).

Under the proposed amendment to Rule 44, manufacturers that outsource sterilisation of their medical devices to a facility holding a valid licence under the Medical Devices Rules, 2017, will no longer have to obtain a separate loan licence for the sterilisation activity.

Earlier, manufacturers had to secure a separate loan licence even when the outsourced sterilisation facility itself held a valid licence. The government said removing the duplication would reduce paperwork, administrative burden and compliance costs, particularly for manufacturers without their own sterilisation facilities.

However, a traceability requirement has been retained. Manufacturers will have to mention the licence number of the sterilisation facility on the medical device label. A six-month transition period has been provided to allow companies to modify labels, packaging and related processes.

The government said the change was intended to balance regulatory oversight with ease of doing business by retaining traceability while simplifying the licensing framework.

In another change, the amendment to Rule 63 includes the European Union (EU) among the stringent regulatory jurisdictions recognised for waiving clinical investigation requirements for medical devices that do not have predicate devices in India.

The provision already recognises the United States, the United Kingdom, Australia, Canada and Japan. With the EU now included, medical devices approved in the EU that meet the eligibility conditions can benefit from the waiver provisions in India.

The move is expected to reduce regulatory timelines for eligible importers and manufacturers and facilitate quicker availability of newer medical technologies to Indian patients.

The amendments follow stakeholder consultations and are part of the government’s broader effort to streamline the regulatory framework for medical devices while maintaining standards for their quality, safety and performance.

The changes are also expected to promote greater international regulatory convergence and improve the competitiveness of India’s medical device industry, the government said.