Exporting to Brazil

Publicado em 03/11/2020 08h28 Atualizado em 03/11/2020 17h08

Exporting products regulated by Anvisa to Brazil might include the need for specific pre-market authorizations issued by regulatory bodies in Brazil. Also, for some classes of products, manufacturers might have to be certified by Anvisa, a process which might include inspections at the place of origin. Requirements vary depending on the product.

Products regulated by Anvisa are subjected to approval at borders when entering Brazil, and might be subjected to physical inspection. Please note that some classes of products may require authorizations prior to their embarkation in the exporting country.

The main regulation about border control to which products regulated by Anvisa are subjected to is the Resolution RDC 81/2008 (available only in Portuguese). There are other product-specific norms that must be observed by companies that wish to export to Brazil.

There are other import regulations applicable to specific cases (available only in Portuguese), such as:

Products that enter Brazil for events and fairs: Resolution RDC 13/2004
Health Services provided during Mass Gathering Events:Resolution RDC 02/2013
Products that enter Brazil during Mass Gathering Events:Resolution RDC 41/2015
Medicines that enter Brazil for use in clinical trials:Resolution RDC 09/2015

Please note that it is not possible for foreign companies to make administrative arrangements for issuing of pre-market authorizations and certificates 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.

As a regulatory authority, please see that Anvisa is not in the position of suggesting Brazilian trade partners to foreign companies.

Controlled Substances

The export of controlled substances to Brazil, in accordance with the international drug control régime and the applicable International Conventions, is subject to special procedures that must be observed by importers and exporters. These requirements might include pre-embarkation authorizations in the country of origin.

Click here to access the updated lists of controlled and prohibited substances in Brazil. The main regulations applicable to controlled substances exported to Brazil are Resolutions RDC 81/2008, RDC 99/2008, RDC 11/2013, RDC 55/2013 and RDC 62/2016.