Govt proposes amendments to speed market access for eligible medical devices

The Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules, 2017, in a move aimed at simplifying regulatory requirements, standardising testing fees and facilitating faster market access for eligible medical devices. The proposals, announced on Monday, cover three areas: outsourced sterilisation, uniform testing fees, and inclusion of the European Union among recognised jurisdictions for waiver of clinical investigation requirements.

The ministry said in a statement that the reforms are intended to promote ease of doing business in the medical device sector by simplifying regulatory requirements, enhancing transparency and facilitating timely access to advanced and innovative medical technologies.

Outsourced sterilisation

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

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.

Uniform testing fees

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 measure is intended to establish a standardised and transparent fee structure across laboratories, reducing ambiguity and variations in testing charges.

EU recognition

Rule 63 of the Medical Devices Rules, 2017 has been amended to include the European Union in the list of countries recognised under stringent regulatory jurisdictions for waiver of clinical investigation requirements for medical devices without predicate devices. The United States, United Kingdom, Australia, Canada and Japan are already recognised under this provision.

According to the ministry, the inclusion of the EU will allow faster access in India to eligible medical devices that have already been approved in the EU, while reducing regulatory requirements and timelines for importers and manufacturers.