International Medical Device Regulators Forum

On 3rd October, 2024, India joined the International Medical Device Regulators Forum (IMDRF) as an affiliate member, providing the country with valuable opportunities for global collaboration in medical device regulation.

Key Points

IMDRF Membership and Role: The IMDRF, established in 2011, is a coalition of global regulators working towards harmonizing medical device regulations worldwide.
Its members include the U.S., European Union, Japan, China, and the World Health Organization (WHO), among others.
India's Application and Approval: India, through the Central Drugs Standard Control Organization (CDSCO), applied for affiliate membership in 2024.
After discussions during the 26th Session of the IMDRF in September 2024 in Seattle, India’s application was approved, marking a significant step in aligning India's regulatory framework with global standards.
Advantages of Membership: As an affiliate member, India will engage in technical exchanges with other regulators, participate in open sessions, and align its regulatory practices with international standards, simplifying global compliance for Indian medical device manufacturers.
Boost for Indian Medical Device Industry: The membership is expected to enhance the competitiveness of India’s medical device industry and strengthen "Brand India" by facilitating global recognition and access to international markets.