Govt eases medical device rules, speeds access to EU-approved products

New Delhi: The government has relaxed licensing requirements for medical device makers that outsource sterilization, removing the need for a separate “loan licence” when the third-party facility already holds a valid licence.

The move is part of amendments to the Medical Devices Rules, 2017, aimed at reducing duplication, compliance costs and delays for manufacturers and improving ease of doing business in India's $15-billion medical device market.

“Under the amended provisions, manufacturers outsourcing product sterilization to another facility holding a valid licence under the Medical Devices Rules, 2017 will no longer be required to obtain a separate loan licence for the outsourced sterilization activity,” the Union health ministry said in a statement on Monday.

Earlier, manufacturers had to secure an additional loan licence even if the contracted sterilization facility was already licensed. After the amendment, companies can simply print the sterilization facility’s licence number on the product label. The government has set a six-month transition period for manufacturers to update their packaging and labelling.

Without owning

A loan licence, obtained from the Central Drugs Standard Control Organisation (CDSCO), allows a device manufacturer to outsource a manufacturing activity to another licensed facility without owning or operating that facility itself.

The government has also included the European Union (EU) in its list of recognized regulatory jurisdictions, allowing advanced medical devices approved in the EU to gain faster access to the Indian market without undergoing local clinical investigations. The European Union joins the US, the UK, Australia, Canada, and Japan under this framework. The amendments are intended to reduce paperwork, shorten market entry timelines, and cut compliance costs for the medical device sector.

“With the inclusion of the European Union, eligible medical devices that have already been approved in the EU will be able to benefit from the waiver provisions, facilitating faster patient access to advanced medical technologies in India,” the health ministry said.

Backing oversight

Rajiv Nath, Forum Coordinator at the Association of Indian Medical Device Industry (AiMeD), said: "India's medical device industry fully supports strong regulatory oversight and patient safety... so that regulatory integrity and industry growth can advance hand in hand."

The health ministry said that the reform seeks to strike a balance between regulatory oversight and ease of doing business by simplifying the licensing framework while retaining an essential traceability mechanism for outsourced sterilization.

The measure is expected to provide greater operational flexibility to manufacturers, facilitate faster and more efficient manufacturing processes, and support the growth and competitiveness of India’s medical device industry, it added.

The move represents an important step towards strengthening the medical device regulatory ecosystem and promoting greater ease of doing business, while continuing to maintain robust standards of quality, safety and performance of medical devices, the ministry said.