India Joins International Medical Device Regulators Forum
The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, has officially become an affiliate member of the International Medical Device Regulators Forum (IMDRF), the ministry announced on Thursday.
The IMDRF is a global network of medical device regulators dedicated to promoting regulatory convergence and ensuring public health and safety. The CDSCO applied for IMDRF membership in August to align its medical device regulatory framework with international standards, receiving approval during the 26th Session of the IMDRF held in Washington, D.C. in September.
The ministry stated, “Achieving affiliate membership in the IMDRF will open significant opportunities for collaboration and reliance with regulatory authorities worldwide,” emphasizing its potential to enhance the “Brand India” in the global market.
Current IMDRF members include regulatory authorities from countries such as the US, Australia, Canada, the European Union, Japan, the UK, Brazil, Russia, China, South Korea, Singapore, and the World Health Organization (WHO).
In conjunction with this new membership, the Health Ministry also introduced comprehensive regulations for medical devices, aimed at aligning India’s regulatory framework with globally accepted standards. This initiative seeks to foster a regulatory environment that encourages growth and innovation in the medical device sector.
The IMDRF membership will help harmonize regulatory requirements globally, simplifying processes for manufacturers and safeguarding public health through collaboration and regulatory alignment.
As an affiliate member, India will participate in IMDRF Open Sessions, facilitating information exchange on various technical topics with other regulators. Discussions will cover the latest regulatory strategies and trends, allowing India to provide feedback based on its experiences and to incorporate IMDRF documents into its regulatory framework.
The ministry noted that this membership will “strengthen the CDSCO’s medical device regulatory system, addressing emerging technical challenges to protect public health and safety while aiming for international recognition of its medical device regulation.”
