Strengthening Regulatory Convergence Across the Western Hemisphere
The Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector brings together industry, government, health care professionals, providers, patients and standardization bodies in the first public-private partnership that extends across the Western Hemisphere focused on achieving medical device regulatory convergence and implementing foundational good regulatory practices.
The Vision of the Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector is one standard, one test, accepted everywhere for any medical technology scope. This Vision implies that medical technology regulators across the Western Hemisphere base their national medical device regulations, standards and conformity assessment criteria on the relevant international standards for medical technology.
Our Mission is to lead the coordination of all materially affected stakeholders to achieve this Vision. This includes promoting regulatory cooperation across the Western Hemisphere to achieve internationally aligned medical technology regulations, standards and conformity assessment requirements within a continual process of convergence to maximize patients access to innovative, effective, life-saving and life-improving medical technologies.
Join the Coalition
To learn more about how your Association, Standards Development Organization or Government agency, can join the Coalition’s activities, please click here.
Click here to learn more about our activities, including meetings and documents released about these engagements.
Click here to access the Coalition’s wide array of resources to inform your organization’s efforts to build and strengthen regulatory convergence capacity.
Click here to see how the Regulatory Coalition’s work is being featured across the region.