In a significant development for the medical device sector, India has officially joined the International Medical Device Regulators Forum (IMDRF) as an affiliate member, as announced by the Union Ministry of Health on Thursday. This new affiliation is expected to create invaluable opportunities for collaboration with regulatory authorities around the world.

The IMDRF, established in 2011, comprises global medical device regulators focused on expediting the adoption of international regulatory harmonization and convergence. Current members include national regulatory authorities from the United States, Australia, Canada, the European Union, Japan, the United Kingdom, Brazil, Russia, China, South Korea, Singapore, and the World Health Organization (WHO).

To align its medical device regulatory system with global standards, enhance the competitiveness of the domestic industry, and boost its transnational presence, the Central Drugs Standard Control Organisation (CDSCO) applied for affiliate membership in the IMDRF in 2024. The health ministry’s statement detailed that after a review of India’s application and discussions with senior CDSCO officials during the 26th Session of IMDRF in September 2024, held in Seattle, Washington, India’s application was approved.

The IMDRF membership will facilitate the harmonization of regulatory requirements worldwide, thereby simplifying complexities for manufacturers and safeguarding public health through enhanced collaboration. As an affiliate member, India will participate in open sessions for information exchange on technical topics, discuss contemporary medical device regulatory strategies and trends, and provide valuable feedback based on its experiences.

This affiliation will bolster the CDSCO’s medical device regulatory framework, addressing emerging technical challenges while ensuring public health and safety. Furthermore, it aims to achieve international recognition for India’s medical device regulations.

The membership is also poised to benefit Indian medical device manufacturers by enabling them to meet the regulatory requirements of IMDRF member countries, thereby strengthening the “Brand India” in the global market. This strategic move underscores India’s commitment to advancing its medical device industry and enhancing its role on the international stage.