U.S. exporters and Brazilian importers must register with the Foreign Trade Secretariat (SECEX), a branch of the Ministry of Economy. Depending on the product, Brazilian authorities may require additional documentation. For instance, the Ministry of Health controls all products that may affect the human body, including pharmaceuticals, vitamins, cosmetics and medical equipment/devices. Such products can only be imported and sold in Brazil if the foreign company establishes a local Brazilian manufacturing unit or local office, or the foreign company appoints a Brazilian distributor who is authorized by the Brazilian authorities to import and distribute medical products. Such products must be registered with Brazil’s Health Regulatory Agency, ANVISA.
The entry of several imported products to Brazil is subject to permission issued by the respective Brazilian authorities that regulate the entry and commercialization of these goods. Goods that require an import license require approval from one or more of sixteen authorities, composed mainly of ministries or regulatory agencies. Usually, these licenses must be requested before the shipment, but in certain cases they can be obtained after the shipment of goods, but prior to customs clearance.