India becomes affiliate member of global medical device regulator IMDRF

India has become an affiliate member of the International Medical Device Regulators Forum, which will open doors to invaluable opportunities for reliance and collaboration with regulatory authorities worldwide, the Union health ministry said on Thursday.

The IMDRF, which was established in 2011, is a group of global medical device regulators whose aim is to speed up the adoption of international medical device regulatory harmonisation and convergence.

Its members include national regulatory authorities of the US, Australia, Canada, the European Union, Japan, the UK, Brazil, Russia, China, South Korea, Singapore and the World Health Organisation (WHO).

"To achieve global alignment in its medical device regulatory system, enhance the competitiveness of the domestic industry and boost transnational prominence, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, applied for Affiliate Membership in the International Medical Device Regulators Forum (IMDRF) in 2024," the health ministry said in a statement.

"After review of India's application for affiliate membership and meeting discussions by the IMDRF Management Committee (MC) with the senior officers of CDSCO during the 26th Session of IMDRF held in September 2024 at Seattle, Washington, USA, the CDSCO has received approval from IMDRF as an affiliate member of the forum," it said.

Becoming an affiliate member of the IMDRF will open doors to invaluable opportunities for reliance and collaboration with regulatory authorities worldwide, it said.

The membership helps to harmonise regulatory requirements across the globe, which reduces complexities for manufacturers and helps safeguard public health by promoting collaboration, harmonising regulations and promoting convergence.

As an affiliate member, India will participate in IMDRF open sessions for information exchange on technical topics with other regulators, to discuss the latest medical device regulatory strategies and trends, provide feedback on its experience and perspectives and use IMDRF documents in part or in whole as the basis for its regulatory framework for medical devices.

This will strengthen the CDSCO's medical device regulatory system, helping meet emerging technical challenges that are increasingly diverse, ensuring the protection of public health and safety, and continuing to maintain the goal of international recognition for its medical device regulation, the statement said.

This membership will also enable Indian medical device manufacturers to meet the regulatory requirements of IMDRF member countries, thereby strengthening the "Brand India" in the global market, it said.