New Delhi: In a recent announcement, the Union Health Ministry revealed that India has become an affiliate member of the International Medical Device Regulators Forum (IMDRF). According to the ministry, this new development will open doors for India to invaluable opportunities for reliance and collaboration with medical regulatory authorities worldwide.
The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, applied for affiliate membership of IMDRF earlier in 2024. The application received approval at the 26th Session of IMDRF in September. The health ministry further explained that the membership will help India in achieving global alignment in its medical device regulatory system, enhance the competitiveness of the domestic industry, and boost transnational prominence. By becoming an affiliate member of IMDRF, India will be able to participate in its open sessions for information exchange on technical topics with other regulators and discuss the latest medical device regulatory strategies and trends. In addition, India will be able to use IMDRF documents as the basis for its regulatory framework for medical devices.
The IMDRF was established in 2011 as a group of global medical device regulators to speed up the adoption of international medical device regulatory harmonization and convergence. Currently, its members include the national regulatory authorities of the US, Australia, Canada, the European Union, Japan, the United Kingdom, Brazil, Russia, China, South Korea, Singapore, and the World Health Organization (WHO).
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