India’s CDSCO becomes affiliate member of International Medical Device Regulators Forum

The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare became an affiliated member of the International Medical Device Regulators Forum (IMDRF) on Thursday following the review of their application for membership by the IMDRF Management Committee, according to an official statement.

As per the statement, this came after the Ministry of Health and Family Welfare came 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.

This was done to have a global alignment for the medical devices regulatory system, enhance the competitiveness of the domestic industry, and increase transnational prominence, after which CDSCO applied to join the IMDRF as an Affiliate Member in 2024.

After meetings and discussions by the IMDRF MC with the senior offices of CDSCO during the 26th Session of IMDRF held in September 2024 in Seattle and Washington in the US, the CDSCO has received approval from IMDRF as an affiliate member of the forum.

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

The IMDRF members include national regulatory authorities from the US, Australia, Canada, the European Union, Japan, the United Kingdom, Brazil, Russia, China, South Korea, Brazil, Singapore, and the World Health Organisation (WHO).

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, the statement read.

It also helps to support innovation and timely access to new medical devices.

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