In Brazil, the National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the regulatory agency that is responsible for the approval and supervision of medical devices, pharmaceuticals, cosmetics and health services among others.
The pre-market approval is the legal act that recognizes the suitability of a product to the Brazilian sanitary regulation, and it is given by Anvisa. Anvisa requires pre-market approvals only for the categories of products that are considered to be of greatest health risk. Once the pre-market submissions are approved and are published in the Official Gazette, the product is authorized to be marketed throughout the Brazilian territory. The marketed product must necessarily correspond to what has been evaluated and approved by Anvisa, and no changes are allowed without prior authorization from the Agency, as established in Article 13 of Law 6360/1976.
Please note that it is not possible for foreign companies to make administrative arrangements for issuing of pre-market approvals directly with Anvisa. Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.