OEM News

IMDRF Expands its Member Countries Total by 15

New participants hail from Latin America, the Middle East, Africa, and India.

By: Michael Barbella

Managing Editor

The International Medical Device Regulators Forum (IMDRF) has welcomed more than a dozen new member countries.

Chaired by the U.S. Food and Drug Administration (FDA), the IMDRF comprises medical device regulators worldwide that voluntarily convene to harmonize various countries’ regulatory requirements for medical products. During the organization’s 26th session, it added 15 new affiliate members: Botswana, Costa Rica, Dominican Republic, El Salvador, Ethiopia, Kenya, India, Jordan, México, Oman, Nigeria, Paraguay, Peru, Tanzania, and Zimbabwe.
 
“The IMDRF has the important mission of harmonizing medtech regulations from country to country,” Advanced Medical Technology Association (AdvaMed) President/CEO Scott Whitaker said. “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 this new platform will help India with its stated goal of achieving global alignment in its medical device regulatory system. In addition, the FDA is performing strongly as the IMDRF chair and cecretariat. 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.”
 
The IMDRF aims to strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges while protecting and maximizing public health and safety.

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