Indian drug regulator joins global med device regulators' club

In a move that will help the Indian medical device industry go global, Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) has joined the International Medical Device Regulators Forum (IMDRF) network as an affiliate member.

Established in 2011, IMDRF is a group of global medical device regulators whose aim is to speed up adoption of international medical device regulatory harmonisation and convergence. IMDRF members include national regulatory authorities from the United States, Australia, Canada, the European Union, Japan, the United Kingdom, Brazil, Russia, China, South Korea, Brazil, Singapore, and the World Health Organization (WHO).

Becoming an affiliate member of IMDRF will provide opportunities to CDSCO for collaboration with regulatory authorities worldwide and help Indian Medical device manufacturers meet regulatory requirements of IMDRF member countries, thus being able to build brand India, the regulatory body stated.

The membership helps to harmonise regulatory requirements across the globe, which reduces the complexity for manufacturers and helps in safeguarding public health by promoting collaboration, harmonising regulations, and promoting convergence. It also helps to support innovation and timely access to new medical devices.

As an affiliate member, India will participate in IMDRF Open Sessions to have information exchange on technical topics with other regulators, discuss on latest medical device regulatory strategies and trends, provide feedback on India’s experience and perspectives, use IMDRF documents in part or in whole as the basis for India’s regulatory framework for Medical Devices.

Indian regulator said 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 Ministry of Health & Family Welfare has already come up with comprehensive regulations for Medical Devices to harmonise its regulatory system at par with globally accepted regulatory requirements and also to have a regulatory ecosystem for the growth of this sector in the country.

India’s application for Affiliate membership in IMDRF was taken up 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.