In a significant move, India has become an affiliate member of the International Medical Device Regulators Forum (IMDRF), a global group focused on harmonising medical device regulations, the Union Health Ministry announced on Thursday. This membership will open new opportunities for collaboration with regulatory authorities worldwide and boost the global competitiveness of India's medical device industry.
According to the news agency, the IMDRF, founded in 2011, aims to promote convergence in medical device regulations across the globe. Its members include regulatory authorities from the US, Australia, Canada, the European Union, Japan, the UK, Brazil, Russia, China, South Korea, Singapore, and the World Health Organization (WHO).
As per the agency reports, the Central Drugs Standard Control Organisation (CDSCO), under India’s Ministry of Health and Family Welfare, applied for affiliate membership in 2024 to align India’s regulatory framework with international standards, enhance the competitiveness of domestic manufacturers, and raise India's profile in the global medical device industry.
After a review of the application and discussions between the IMDRF Management Committee and senior CDSCO officials during the 26th IMDRF session in Seattle, Washington, India's affiliate membership was approved.
This new status will allow India to collaborate with global regulators and contribute to discussions on the latest medical device strategies and regulatory trends. As an affiliate member, India can exchange information on technical topics, provide feedback on its experiences, and use IMDRF documents as a basis for its own regulatory framework for medical devices.
The Health Ministry emphasised that this membership would strengthen the CDSCO’s regulatory system and help India address emerging technical challenges while ensuring public health and safety. The alignment with global regulations is expected to simplify processes for manufacturers, reduce regulatory complexities, and enhance international recognition for India's medical device industry.
Furthermore, Indian medical device manufacturers will now meet the regulatory standards of IMDRF member countries, helping to promote "Brand India" in the global market. This membership marks a significant step in India's efforts to harmonize its medical device regulations with global standards, enhancing both its domestic industry and international reputation.
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