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...
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...
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,...
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.