India Achieves Affiliate Membership in International Medical Device Regulators Forum

By promoting the convergence of regulations, the IMDRF supports innovation and expedites access to new medical devices.

The Ministry of Health and Family Welfare has unveiled comprehensive regulations for medical devices, aiming to align India’s regulatory framework with globally accepted standards. This initiative seeks to create a regulatory ecosystem that fosters growth and innovation within the medical device sector.

As part of its strategy to achieve global alignment in its medical device regulatory system and enhance the competitiveness of the domestic industry, the Central Drugs Standard Control Organization (CDSCO) applied for Affiliate Membership in the International Medical Device Regulators Forum (IMDRF) in 2024. Following a review of India's application and discussions between the IMDRF Management Committee and senior CDSCO officers during the 26th Session of the IMDRF held in September 2024 in Seattle, Washington, the CDSCO has officially received approval as an Affiliate Member.

Established in 2011, the IMDRF is a collaborative group of global medical device regulators committed to accelerating the harmonization and convergence of international medical device regulations. Its members include national regulatory authorities from countries such as the United States, Australia, Canada, the European Union, Japan, the United Kingdom, Brazil, Russia, China, South Korea, Singapore, and the World Health Organization (WHO). India's new Affiliate Membership will provide significant opportunities for collaboration and reliance on regulatory authorities worldwide.

The benefits of this membership include harmonizing regulatory requirements globally, which simplifies compliance for manufacturers and enhances public health safety through collaborative efforts. By promoting the convergence of regulations, the IMDRF supports innovation and expedites access to new medical devices.

As an affiliate member, India will participate in IMDRF Open Sessions, facilitating information exchange on technical topics with other regulators and discussions on the latest medical device regulatory strategies and trends. India will also have the opportunity to share its experiences and perspectives while using IMDRF documents as a foundation for its medical device regulatory framework. This engagement is expected to strengthen the CDSCO’s regulatory system, helping it address emerging technical challenges to ensure public health and safety while striving for international recognition.

Furthermore, this membership will enable Indian medical device manufacturers to align with the regulatory requirements of IMDRF member countries, thereby reinforcing "Brand India" in the global market. This achievement reflects India's commitment to enhancing its medical device industry and ensuring the highest standards of safety and efficacy for its citizens.