Press Releases

AdvaMed Welcomes India, New Member Countries from Latin America, Middle East, Africa to IMDRF

Washington, D.C. – The International Medical Device Regulators Forum (IMDRF) consists of medical device regulators from around the world that voluntarily convene to harmonize the regulatory requirements for medical products varying from country to country. The U.S. FDA is the Chair and Secretariat of the IMDRF for 2024 and recently hosted its 26th session. The IMDRF added 15 new affiliate members this year (Botswana, Costa Rica, Dominican Republic, El Salvador, Ethiopia, Kenya, India, Jordan, México, Oman, Nigeria, Paraguay, Peru, Tanzania, and Zimbabwe).

Scott Whitaker, president and CEO of AdvaMed, the world’s largest medtech trade association, made the following comment on India’s joining the IMDRF and the additional expansion of member countries.

“The IMDRF has the important mission of harmonizing medtech regulations from country to country. This leads to more efficient patient access to medtech innovations globally. The organization has done a great job adding new affiliate members from Latin America, Africa, the Middle East, and India. India’s joining of the esteemed ranks of the IMDRF is welcome news. We expect that this new platform will help India with its stated goal of achieving global alignment in its medical device regulatory system.

“In addition, the U.S. FDA is performing strongly as the IMDRF Chair and Secretariat. Welcoming new member countries and ensuring their productive participation is just what patients ultimately need. AdvaMed commends the FDA for its work and welcomes India as a pivotal medtech hub to an organization that does so much for public health.”