Exporting to Brazil
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: RDC 13/2004
- Health Services provided during Mass Gathering Events: RDC 02/2013
- Products that enter Brazil during Mass Gathering Events: RDC 41/2015
- Medicines that enter Brazil for use in clinical trials: 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.