Centre Proposes Medical Device Rule Changes

• Outsourced sterilisation facilities may no longer require a separate loan licence.
• Uniform testing fees proposed for medical device testing laboratories.
• European Union to join recognised jurisdictions for clinical investigation waivers.
• Changes aim to improve transparency, predictability and ease of doing business.

GG News Bureau
New Delhi, 24th Aug: The Union Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules, 2017, aimed at simplifying regulatory requirements, reducing compliance costs and facilitating faster access to advanced medical technologies in India.

The proposed reforms cover three key areas: outsourced sterilisation of medical devices, standardisation of testing fees and recognition of the European Union as a stringent regulatory jurisdiction for specified clinical investigation waivers.

Simplified Rules for Outsourced Sterilisation
Under the proposed amendment to Rule 44, manufacturers using outsourced sterilisation facilities will not need to obtain a separate loan licence under Rule 25, provided the sterilisation facility holds a valid licence under the Medical Devices Rules, 2017.

Previously, manufacturers without in-house sterilisation facilities were required to obtain a separate loan licence for sterilisation activities.

The change is expected to reduce documentation, approval timelines and compliance costs while allowing manufacturers to use specialised sterilisation facilities more efficiently.

Uniform Testing Fees Proposed
The Ministry has also proposed inserting a Ninth Schedule into the Medical Devices Rules, 2017, prescribing uniform fees for testing medical devices by Medical Device Testing Laboratories.

The standardised fee structure is intended to bring greater transparency and predictability to testing charges and reduce variations and potential disputes among laboratories, manufacturers and importers.

EU Added to Recognised Regulatory Jurisdictions
Another proposed change concerns Rule 63, under which the European Union would be added to the list of recognised stringent regulatory jurisdictions for waiving clinical investigation requirements for certain medical devices without predicate devices.

The existing list includes the United States, United Kingdom, Australia, Canada and Japan.

The inclusion of the EU is expected to facilitate faster access in India to eligible medical devices already approved in the European Union, while reducing regulatory timelines and associated burdens for manufacturers and importers.

Focus on Regulatory Convergence
The Ministry said the proposed reforms are aimed at strengthening India’s medical device regulatory ecosystem while maintaining high standards of quality, safety and performance.

The measures are expected to improve regulatory transparency and predictability, reduce compliance costs and support greater international regulatory convergence, while facilitating the timely availability of innovative medical devices in the Indian market.