AdvaMed signs partnership to boost regulatory standards for medtech

The Advanced Medical Technology Association (AdvaMed) will work with the US Agency for International Development (USAID) to help strengthen regulatory standards for medical technology across Latin America, Africa and Southeast Asia.

The multi-year partnership will see AdvaMed providing direct contribution for training, as well as staff time and technical expertise, all aimed at increasing regulatory “convergence” across the regions through 2023.

The project is part of a matching grant program, with USAID providing funds matching AdvaMed and partner contributions dollar for dollar up to $3 million.

In part, it is designed to help strengthen efforts against Covid-19, with Scott Whitaker, AdvaMed president and CEO highlighting the need for co-operation across borders when it comes to getting lifesaving medical technologies to patients.

“The more similar laws and regulations are from country to country around the world, the better off patients will be. Expanding adoption of strong international standards and effective, common regulatory practice makes it easier and more efficient to get lifesaving medical technologies to the patients and providers who need them wherever they are in the world,” said Scott Whitaker, AdvaMed president and CEO. “This is even more important in the middle of a global fight against Covid-19 that requires cooperation across borders.” 

“The initiative will facilitate public-private sector cooperation, trade and U.S. medtech exports, including access to Covid-19 tests, personal protective equipment and other essential supplies to fight the pandemic,” added Ralph Ives, AdvaMed executive vice president, global strategy and analysis. “This will help get the latest advances into the hands of health care providers on the front lines of the global health emergency.”

The partnership builds on AdvaMed’s existing work with the American National Standards Institute (ANSI) to address Covid-19 response and recovery and also advance good regulatory practices for medtech.