New Amendments Aim to Fast-Track Market Access for Eligible Medical Devices

The government proposed amendments to the Medical Devices Rules, 2017, to simplify regulatory requirements, standardise testing fees and facilitate faster market access for eligible medical devices, an official statement said on Monday.

"The government has undertaken key regulatory reforms in the medical device sector to promote Ease of Doing Business (EoDB) by simplifying regulatory requirements, enhancing transparency and facilitating timely access to advanced and innovative medical technologies in the country," the statement from the Ministry of Health and Family Welfare (MoHFW) said.

The amendments focus on three areas—simplification of provisions relating to outsourced sterilisation of medical devices, introduction of uniform testing fees and inclusion of the European Union among recognised jurisdictions for waiver of clinical investigation requirements.

Under the amended provisions of Rule 44 of the Medical Devices Rules, 2017, manufacturers availing outsourced sterilisation facilities will no longer be required to obtain a separate loan licence under Rule 25, provided that the sterilisation facility holds a valid licence under the Medical Devices Rules, 2017.

Earlier, manufacturers without an in-house sterilisation facility were required to obtain a separate loan licence for sterilisation activities, the MoHFW said.

The amended provision is expected to reduce regulatory compliance requirements, documentation, approval timelines and associated costs, while enabling manufacturers to efficiently avail specialised sterilisation facilities.

Further, a Ninth Schedule has been inserted in the Medical Devices Rules, 2017 prescribing uniform fees for the testing of medical devices by Medical Device Testing Laboratories, the statement noted. The measure will establish a standardised and transparent fee structure across laboratories, reducing ambiguity and variations in testing charges.

The standardised fee structure is expected to provide greater predictability to manufacturers and importers, minimise disputes, ensure equitable treatment of stakeholders and further strengthen transparency and efficiency in the medical device regulatory framework.

Rule 63 of the Medical Devices Rules, 2017 has also 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 presently recognises the United States of America, United Kingdom, Australia, Canada and Japan. The inclusion of the European Union will facilitate faster access in India to eligible medical devices that have already been approved in the EU, while reducing regulatory burden and timelines for importers and manufacturers.