India’s CDSCO Joins International Medical Device Regulators Forum
The Central Drugs Standard Control Organisation (CDSCO) in India has become an affiliated member of the International Medical Device Regulators Forum (IMDRF). This decision was made after the IMDRF Management Committee reviewed CDSCO’s application. The Ministry of Health and Family Welfare in India developed comprehensive regulations for medical devices to align with global standards and enhance the domestic industry’s competitiveness.
During the 26th Session of the IMDRF held in September 2024 in Seattle and Washington, USA, senior officials from CDSCO met with the IMDRF Management Committee. Following these discussions, CDSCO’s membership was approved. The IMDRF, established in 2011, includes regulatory authorities from countries like the US, Australia, Canada, and others, aiming to harmonize international medical device regulations.
As an affiliate member, India will participate in IMDRF Open Sessions to exchange information on technical topics, discuss regulatory strategies, and provide feedback on India’s experiences. This membership will help strengthen India’s medical device regulatory system, ensuring public health and safety while supporting innovation and timely access to new medical devices.
Doubts Revealed
CDSCO -: CDSCO stands for Central Drugs Standard Control Organisation. It is the national regulatory body in India responsible for regulating drugs and medical devices to ensure their safety and effectiveness.
IMDRF -: IMDRF stands for International Medical Device Regulators Forum. It is a group of medical device regulators from around the world who work together to harmonize regulations and improve the safety and quality of medical devices globally.
Affiliate member -: An affiliate member is a type of membership that allows an organization to participate in discussions and activities without being a full member. It helps the organization learn and contribute to the group’s goals.
Regulatory framework -: A regulatory framework is a set of rules and guidelines that an organization or country follows to ensure that products, like medical devices, are safe and effective for public use.
Public health safety -: Public health safety refers to measures and practices that protect the health of the general public, ensuring that products like medicines and medical devices do not cause harm.
