Centre proposes easing medical device rules: sterilisation licence burden removed, EU added for faster approvals

The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, aimed at simplifying regulatory requirements and accelerating market access for medical devices in India. The changes, announced on Monday (August 24, 2026), focus on two key areas: outsourced sterilisation and recognition of additional stringent regulatory jurisdictions.

Under the proposed amendment to Rule 44, manufacturers who outsource sterilisation of their medical devices to a facility holding a valid licence under the Medical Devices Rules, 2017, will no longer be required to obtain a separate loan licence for the sterilisation activity. Previously, manufacturers had to secure a separate loan licence even when the outsourced facility already possessed a valid licence. The government said this duplication added unnecessary paperwork, administrative burden, and compliance costs, particularly for manufacturers without their own sterilisation capabilities.

However, the government has retained a traceability requirement to ensure regulatory oversight is not weakened. Manufacturers will still need 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 accordingly.

In a separate change, the amendment to Rule 63 adds the European Union (EU) to the list of stringent regulatory jurisdictions recognised for waiving clinical investigation requirements for medical devices that do not have predicate devices in India. A predicate device is a legally marketed similar device already available in the country. The list already includes 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.

This move is expected to reduce regulatory timelines for eligible importers and manufacturers, thereby facilitating quicker availability of newer medical technologies to Indian patients. It also aims to promote international regulatory convergence and improve the competitiveness of India’s medical device industry, according to the government.

The proposed 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 quality, safety, and performance. The health ministry stated that the changes strike a balance between regulatory oversight and ease of doing business, ensuring patient safety while reducing unnecessary compliance burdens.

Industry observers say the removal of the separate sterilisation licence requirement will benefit small and medium-sized manufacturers who rely on third-party sterilisation services, potentially lowering costs and encouraging domestic production. The inclusion of the EU in the waiver list could also attract more foreign manufacturers to seek Indian market approval, which may expand patient access to advanced medical technologies.

It is important to note that these amendments are proposals and will take effect only after the formal rule-making process is completed. The government has not yet specified a timeline for final notification.