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.
Vision
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.
Mission
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.
COVID-19: MEDTECH INDUSTRY RESPONSE
REGULATORY COALITION PRINCIPAL MEMBERS
