Regulation of products

General information on pre-market approvals and notifications

The pre-market approval is the legal act that recognizes the compliance of a product with Brazilian sanitary regulations, and it is granted by Anvisa. It is a preventive control measure applied before commercialization, used in cases where products may present potential health risks.

Anvisa requires pre-market approvals ("registro") only for categories of products that are considered to present the greatest health risks. Other categories of products subject to sanitary regulation are exempt from pre-market approval because they represent lower health risks, as established in Article 41 of Law 9.882/1999. In some cases, these lower-risk products must be notified to Anvisa before being placed on the market, which is a simplified regulatory pathway that does not involve prior analysis by the Agency.

Pre-market approvals and notifications are published in the Official Gazette, and this publication is sufficient to prove the authorization granted by Anvisa, making the subsequent issuance of any other documents, such as certificates or declarations, unnecessary.

Once published in the Official Gazette, the product is authorized for commercialization throughout the Brazilian territory. The product marketed must correspond exactly to what was evaluated and approved by Anvisa, and no changes are permitted without prior authorization from the Agency, as established in Article 13 of Law 6.360/1976.

To verify whether a product is duly authorized (registered) or notified, Anvisa provides an online query tool that is publicly accessible: Consulta de Produtos Regularizados (Portuguese only). This platform allows users to search for information on products that have been evaluated or notified by the Agency.

It should be noted that foreign companies cannot directly carry out administrative procedures for obtaining pre-market approvals with Anvisa. They must designate legally established partner companies in Brazil, which will assume legal responsibility for the products imported and distributed within the Brazilian territory.