South America
Lets talk about current medical device regulations in Mexico. Medical devices in Mexico are regulated by the Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). The agency classifies...
South America
In Brazil, the institution that oversees medical device regulations is the Brazilian National Health Surveillance Agency (ANVISA). The beginning of the medical device registration process requires the classification of the device according to the level of risk it...
South America
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) is the institution responsible for regulating medical devices in Argentina. ANMAT uses a risk-based classification system and, similarly to the European Union and Canada, classifies medical...
South America
Brazil is the largest medical device market in Latin America, and has an established but complex regulatory system. Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA). ANVISA in its effort to streamline medical device...
South America
Here are steps for proper device labeling in Brazil: The Brazilian Consumer protection code requires that product labeling should provide the consumer with accurate, concise and easily readable information. about the product’s quality, quantity, composition,...
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