In a major step towards strengthening its medical device regulatory framework, India’s Ministry of Health and Family Welfare has introduced new regulations to align with global standards. The Central Drugs Standard Control Organization (CDSCO), the regulatory body for medical devices in India, secured Affiliate Membership in the International Medical Device Regulators Forum (IMDRF) in September 2024.
With members from major countries such as the United States, Japan, Australia, Canada, the European Union, the United Kingdom, Brazil, Russia, China, South Korea, Singapore, and the World Health Organization (WHO), India’s affiliation signifies a major leap for the country’s regulatory landscape.
By becoming an IMDRF affiliate, India welcomes new opportunities to exchange technical information with global regulators, adopt IMDRF guidelines, and enhance its domestic regulatory system. As an affiliate member, CDSCO will engage in open discussions, contribute feedback, and utilize IMDRF documents as part of its medical device regulations. Furthermore, this new path will enable smoother regulatory processes, promote timely access to medical devices, and ensure that Indian products meet international safety and quality standards.
This strategic alignment will ease the process for Indian manufacturers to access global markets, bolster India’s standing in the international medical device industry, and strengthen the “Brand India” in the competitive global medical device market.
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