Latin America
Brazil, Argentina & Colombia-
The Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária – ANVISA) is an autonomous regulatory body linked to the Ministry of Health, part of the Brazilian National Health System. Manufacturers exporting medical products to Brazil will have to be certified by ANVISA, a process which might include inspections at the place of origin.
-
The Argentinean National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica – ANMAT) is the medical device market regulator within Argentina, assuring the quality of medical, cosmetic and drug products within the country. Requirements vary depending on the product.
-
In Colombia, the National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos – INVIMA) is the regulatory agency responsible for regulating registration of medical products and devices. INVIMA is in charge of supervising and evaluating procedures of medical manufacturers and providing approval for the import and export of healthcare products within Colombia.