Context:

Recently, India’s CDSCO became an affiliate member of the International Medical Device Regulators Forum (IMDRF).

More on the news

• In 2024, the Central Drugs Standard Control Organization (CDSCO) applied for Affiliate Membership in the International Medical Device Regulators Forum (IMDRF) to align India’s medical device regulatory system globally and enhance the competitiveness of its domestic industry. 
• After discussions at the 26th Session of IMDRF in Seattle, USA, in September 2024, the CDSCO received approval from IMDRF as an Affiliate Member of the Forum.

International Medical Device Regulators Forum (IMDRF)

• It was established in 2011, as a collaborative group of global medical device regulators whose aim is to boost the adoption of international medical device regulatory harmonisation and convergence.
• IMDRF is a voluntary group of medical device regulators from around the world.
• IMDRF members include national regulatory authorities from Australia, Brazil, Canada, China, the European Union, Japan, the United Kingdom, Russia, South Korea, Singapore and the United States, as well as the World Health Organization (WHO).
• The 2024 IMDRF Chair and Secretariat is held by the United States of America.

Significance of Membership

• The membership will help India to harmonise global regulatory requirements, simplifying compliance for manufacturers and enhancing public health through collaboration and convergence.
• It supports innovation and facilitates timely access to new medical devices.
• This membership strengthens "Brand India" by enabling Indian manufacturers to meet IMDRF member countries' regulatory standards, boosting global market presence. 

About Central Drugs Standard Control Organisation (CDSCO)

• CDSCO is the National Regulatory Authority (NRA) of India and works under the Directorate General of Health Services, Ministry of Health & Family Welfare.
• It is a statutory body under the Drugs & Cosmetics Act, 1940.

Functions of CDSCO:

Under the Drugs and Cosmetics Act, CDSCO is responsible for – 

• Approval of new drugs, 
• Conduct of Clinical Trials,
• Laying down the standards for Drugs,
• Controlling the quality of imported Drugs in the country, and 
• Coordination of the activities of State Drug Control Organizations by providing expert advice to bring about uniformity in the enforcement of the Drugs and Cosmetics Act.