As the medical technology industry combats COVID-19, Coalition Executive Committee member, the Advanced Medical Technology Association (AdvaMed), announced on 22 September 2020 that the U.S. Agency for International Development (USAID) has approved a multi-year partnership titled COVID-19 Medical Device Regulatory Convergence (MDRC).
Through this public-private partnership, AdvaMed will coordinate with medical device industry associations as well as standards development organizations to increase the adoption of medical technology-specific international standards and good regulatory practices by governments across Latin America through the Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector. This will be achieved by providing resources as well as leveraging the collective contributions and expertise of affected stakeholders.
“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.”
Building on AdvaMed’s existing partnership with the American National Standards Institute (ANSI) under the Standards Alliance Initiative, this new and expanded partnership will provide direct support for the Inter-American Coalition through 2023 to foster implementation of good regulatory practices for medical technology and lower trade barriers across Latin America, with focus on Brazil, Colombia, Mexico and Peru, as part of the region’s response to and recovery from COVID-19.
The Inter-American Coalition will also serve a central role with MDRC in global medical technology regulatory convergence efforts in the wake of COVID-19. This includes the launch of an International Center for Emergency Regulatory Response in the form of a dedicated COVID-19 medical device work stream as well as an easily navigable COVID-19 medical device online portal that compiles available information on the newest medical devices released by the industry to combat the pandemic.