The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has introduced new regulations for medical devices aimed at aligning India’s regulatory framework with globally accepted standards. This initiative seeks to foster a regulatory environment that promotes growth and innovation in the medical device sector.
In pursuit of global alignment and to enhance the competitiveness of the domestic industry, the CDSCO applied for Affiliate Membership in the International Medical Device Regulators Forum (IMDRF) in 2024. Following a review of India’s application and discussions with senior CDSCO officials during the 26th session of the IMDRF held in September 2024 in Seattle, Washington, the CDSCO was approved as an Affiliate Member of the Forum.
The IMDRF, established in 2011, is a collaborative group of global medical device regulators, including authorities 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). Achieving Affiliate Membership in the IMDRF will allow the CDSCO to collaborate and align its regulatory framework with international standards.
As an affiliate member, CDSCO will participate in IMDRF Open Sessions, exchange information on technical topics with other regulators, and discuss the latest medical device regulatory strategies and trends. The CDSCO will also use IMDRF documents as part of its regulatory framework for medical devices, helping strengthen its regulatory system to meet emerging technical challenges and safeguard public health.
This membership will enable Indian medical device manufacturers to meet the regulatory requirements of IMDRF member countries, further bolstering the global competitiveness of “Brand India” in the medical device sector.
CDSCO joining the International Medical Device Regulators Forum as an affiliate member is a significant step towards enhancing global collaboration in medical device regulation. This affiliation will help harmonize standards and improve safety and efficacy for consumers. It’s an exciting development for the Indian medical device landscape!