India Joins International Medical Device Regulators Forum

October 5, 2024

On October 3, 2024, India’s Union Health Ministry announced that the country has become an affiliate member of the International Medical Device Regulators Forum (IMDRF). This is a big step for India because it will allow the country to work closely with other countries to improve how medical devices are regulated and approved.

What is the IMDRF?

The IMDRF was created in 2011 and is a global group of organizations that regulate medical devices. Its goal is to make sure that medical devices are safe and follow the same standards around the world. Some of the key members of the IMDRF are countries like the United States, the European Union, Japan, and even the World Health Organization (WHO).

India’s Membership Application

India, through its Central Drugs Standard Control Organization (CDSCO), applied for membership in 2024 to better align its medical device regulations with international standards. By doing this, India hopes to improve the quality and safety of medical devices made in the country and make it easier for these devices to compete in the global market.

Approval Process

India’s application to join the IMDRF was carefully reviewed. Discussions took place during the 26th IMDRF session in September 2024 in Seattle. After considering India’s readiness, the IMDRF Management Committee approved India’s request to become an affiliate member.

Implications of Membership

By becoming an affiliate member, India will have better opportunities to work with other countries on medical device regulations. This collaboration can help improve patient safety and make India a bigger player in the global medical device market.

About International Medical Device Regulators Forum (IMDRF)

The IMDRF was set up to improve how medical devices are regulated across different countries. It works on developing guidelines for things like risk management and medical software. One of its notable ideas is introducing “e-labeling”, which allows medical devices to have digital labels instead of printed ones. The IMDRF meets every three months to check on the progress of their projects, and members include important organizations like the FDA (U.S.), EMA (Europe), and Health Canada.

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