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Govt ends loan licensing requirement for outsourced medical device sterilisation
The government said it amended the Medical Devices Rules to promote ease of doing business and simplify regulatory processes
The Union health and family welfare ministry has done away with the additional requirement for a separate loan license for medical device manufacturers outsourcing sterilization of their products by amending the Medical Devices Rules, 2017, to promote ease of doing business, simplify regulatory processes, and enhance transparency, it said.
In a statement, the ministry said the move is aimed at facilitating timely access to advanced medical technologies. The license number of the sterilisation facility has to be mentioned on the medical device label, it added.
The manufacturers had to previously obtain a separate loan license if they outsourced sterilisation. This was an additional regulatory requirement, even when the sterilisation facility had a license under the Medical Devices Rules, 2017, according to people familiar with the matter.
The ministry said the rules were amended to simplify the regulatory framework governing outsourced sterilisation of medical devices and to expand the list of recognised stringent regulatory jurisdictions for waiver of clinical investigation requirements.
It added that the amendment to Rule 44 was finalised after extensive stakeholder consultations to simplify regulatory compliance for medical device manufacturers availing 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.
The amended provision provides a six-month transition period for implementing the new labelling requirement. It allows manufacturers adequate time to make necessary changes to their packaging and related processes before the provision comes into effect.
“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.
Rule 63 has been amended to include the European Union (EU) among the recognised stringent regulatory jurisdictions for waiver of clinical investigation requirements for medical devices without predicate devices.
The provision earlier recognised the US, the UK, Australia, Canada, and Japan. With the inclusion of the EU, devices approved in the member countries will benefit from the waiver provisions, facilitating faster patient access to advanced medical technologies.
The ministry said the amendment is expected to reduce the regulatory burden and associated timelines for importers and manufacturers. It added that this will strengthen international regulatory convergence in the medical device sector.
The ministry said the reforms are expected to reduce costs and facilitate the timely availability of advanced and innovative medical devices. “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.”
