The Central Drugs Standard Control Organization (CDSCO), operating under the Ministry of Health and Family Welfare, has officially become an affiliate member of the International Medical Device Regulators Forum (IMDRF), according to a recent announcement from the ministry.

About IMDRF: IMDRF is a global consortium of medical device regulatory authorities dedicated to enhancing regulatory alignment and ensuring public health and safety.

The CDSCO applied for membership in August, aiming to align its medical device regulations with international standards. Approval was granted during the 26th IMDRF session held in Washington, D.C. in September.

Benefits of Membership: The ministry noted that this affiliate status will facilitate significant opportunities for collaboration and reliance among global regulatory bodies, enhancing India's presence in the international market.

Current members of IMDRF include regulatory agencies from the United States, Australia, Canada, the European Union, Japan, the United Kingdom, Brazil, Russia, China, South Korea, Singapore, and the World Health Organization (WHO).

To further align with global standards, the Health Ministry also introduced new regulations for medical devices. This initiative aims to create a regulatory framework that promotes growth and innovation in the sector while adhering to internationally accepted standards.

Additionally, the IMDRF membership will help harmonize regulatory requirements worldwide, simplifying processes for manufacturers and bolstering public health through enhanced collaboration and regulatory convergence. This will also support timely access to innovative medical devices.

As an affiliate member, India will engage in IMDRF Open Sessions, facilitating the exchange of information on various technical topics with other regulators. These discussions will cover the latest regulatory strategies and trends in the medical device sector, allowing India to share its experiences and perspectives while utilizing IMDRF guidelines as a basis for its own regulatory framework.

The ministry stated that this membership will strengthen the CDSCO's regulatory system for medical devices, enabling it to address emerging technical challenges and ensuring public health and safety, while pursuing international recognition in medical device regulation.

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