India joins International Medical Device Regulators Forum as affiliate member

New Delhi: As per reports, India has become an affiliate member of the International Medical Device Regulators Forum (IMDRF), marking a significant step toward global collaboration in the medical device regulatory landscape, the Union Health Ministry announced on October 3, 2024. This membership is expected to create new avenues for cooperation with regulatory authorities worldwide, enhancing India’s role in the global medical device sector.

The IMDRF, formed in 2011, aims to promote international harmonisation of medical device regulations, facilitating faster adoption of global standards. Its current members include regulatory bodies from the United States, Australia, Canada, the European Union, Japan, the UK, Brazil, Russia, China, South Korea, Singapore, and the World Health Organization (WHO).

India’s Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, applied for this membership to align its medical device regulatory framework with global standards, boost the competitiveness of its domestic industry, and increase its international prominence. Following a thorough review of India’s application and discussions with senior CDSCO officials during the 26th IMDRF session held in Seattle, Washington, in September 2024, India’s affiliate membership was approved.

The Health Ministry emphasised that this affiliation will help streamline global regulatory requirements, reducing complexities for manufacturers while safeguarding public health through enhanced collaboration and harmonisation of regulations. As an affiliate member, India will now participate in IMDRF’s open sessions, enabling the exchange of information on technical topics, discussions on regulatory strategies and trends, and the opportunity to provide feedback from its own regulatory experiences.

This membership is expected to further strengthen CDSCO’s regulatory framework for medical devices, helping address emerging technical challenges while ensuring public safety. Additionally, it will provide Indian medical device manufacturers easier access to meet the regulatory requirements of IMDRF member nations, boosting India’s global presence in the medical device market and strengthening the “Brand India” initiative.