The Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector (“the Coalition”) serves as the first and only initiative across the Western Hemisphere to achieve medical device regulatory convergence and implement cross-sectoral good regulatory practices.
All members of the Coalition for Regulatory Convergence for the Medical Technology Sector adhere to “The Bogota Principles” (1).
Regulatory Convergence in the medical technology sector is crucial to facilitating high-standard ethical conduct and reducing corruption risks across the Western Hemisphere.
Launched 2020, the Coalition engages all stakeholders and organizes private sector positioning, training and communication with governments to minimize regulatory barriers between patients and access to life-saving and life-improving medical technologies.
Central to this work is private and public engagement in the development and use of international standards as a basis for national regulations and conformity assessment measures across the Americas. The Coalition also promotes the implementation of foundational, cross-sectoral good regulatory practices (GRP) that can institutionalize “whole-of-government” regulatory approaches and remove limits to sector-specific regulatory convergence efforts. Today, the Coalition has unified the 17 largest industry bodies for the medical technology sector in the region, enabling them to provide hemispheric industry consensus recommendations for regulatory convergence priorities. Based in 10 countries, these 17 industry bodies serve over 3,000 member companies who develop, manufacture, distribute, or support the utilization of medical technology. These companies operate across every country in the hemisphere and serve as the overwhelming majority of enterprises operating in the sector.
At the 2018 Summit of the Americas and Americas Business Dialogue (ABD) in Lima, Peru, the U.S. Secretary of Commerce in collaboration with public and private sector leaders from Argentina, Brazil, Colombia, Peru, and the Inter-American Development Bank (IDB) recognized the Coalition’s leadership and members in promoting ethical conduct and eliminating regulatory barriers to regional trade.
In July 2020, the Coalition will approve its action plan, objectives and metrics through 2025.
(1) Please click here to access “The Bogota Principles”.