Government eases medical device rules, removes separate licence for outsourced sterilisation

The Union Health Ministry has removed an additional licensing requirement for medical device manufacturers that outsource the sterilisation of their products, in a move aimed at simplifying compliance and reducing regulatory delays.

The change has been introduced through amendments to the Medical Devices Rules, 2017. The ministry said the revised framework is intended to improve ease of doing business while ensuring that outsourced sterilisation remains traceable.

Separate loan licence requirement removed

Earlier, manufacturers that used an external facility for sterilising medical devices were required to obtain a separate loan licence, even when the facility carrying out the sterilisation already held a valid licence under the Medical Devices Rules, 2017.

The Ministry said Rule 44 has now been amended after consultations with stakeholders. The change removes the additional licensing process for manufacturers using outsourced sterilisation facilities.

“The amendment eliminates the requirement for a separate loan licensing process in such cases, thereby reducing duplication, administrative burden, compliance costs and associated timelines, particularly for manufacturers that do not have in-house sterilization facilities,” said the statement, as reported by Hindustan Times.

However, manufacturers will still have to mention the licence number of the sterilisation facility on the medical device label. A six-month transition period has been provided for the new labelling requirement, giving companies time to update packaging and related processes.

The Ministry said the revised system is intended to retain regulatory oversight while making the process less cumbersome.

“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 sterilisation. 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,” said the Ministry.

EU added to recognised regulatory jurisdictions

The government has also amended Rule 63 to include the European Union among the stringent regulatory jurisdictions recognised for waiving clinical investigation requirements for certain medical devices without predicate devices.

Previously, the list included the US, UK, Australia, Canada and Japan. With the EU added, devices approved in member countries can benefit from the waiver provisions.

According to the ministry, the change could reduce regulatory timelines for manufacturers and importers while helping bring advanced medical technologies to patients more quickly.

Focus on easier regulatory compliance

The Ministry said the amendments are expected to lower compliance costs and strengthen regulatory convergence in the medical device sector.

“The measures represent 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.”