Import of products regulated by Anvisa: step by step

It’s no surprise that the importation rules for products regulated by Anvisa are quite stringent, requiring the support of companies specialized in foreign trade transactions. 

Whether for quality control or safety reasons, this agency establishes various regulations, permits, licenses, and permissions for certain goods and inputs to be imported into the country, such as medications, chemicals, foods, cosmetics, and fertilizers.

Continue reading and understand well what the law on the importation of products regulated by ANVISA says

What is Anvisa?

Created by Law no. 9.782/1999, the National Health Surveillance Agency (Anvisa) is a regulatory body linked to the Federal Government. Although its headquarters are in the Federal District, the agency is present throughout the country’s territory, especially in customs facilities such as borders, ports, and airports.

The purpose of Anvisa is to promote the protection of the population’s health through stringent sanitary control measures of health-related services and products, as well as control over the importation processes of these goods through customs points, as previously mentioned.

Anvisa’s import law

The Collegiate Board Resolution – RDC No. 81/2008 is the law that determines the norms for the importation of products regulated by Anvisa, as it contains the Technical Regulation of Imported Goods and Products for the purpose of Health Surveillance.

As already demonstrated, Anvisa is one of the most important regulatory agencies responsible for overseeing and monitoring foreign trade operations related to goods under health surveillance. Its mission is to control imports of health products.

For companies to import such merchandise, they must have the Authorization for Operation (AFE) from Anvisa, according to the law on Importation of Health Products, and through the Import License (LI) in Siscomex.

What is importing health products?

Although the term specifies the health sector, the importation of products regulated by Anvisa encompasses various other types of merchandise that require strict quality control. Additionally, they may contain harmful substances that need to be closely monitored, such as chemicals and fertilizers.

Particularities and challenges of importing from Anvisa

Although Anvisa is linked to the Federal Government, the issuance of the sanitary permit for the importation of products falls under the responsibility of municipalities, which may have their own specifications and requirements for issuing the authorizations. 

Considering that Brazil has more than 5,500 municipalities, it is essential for the importer to seek the assistance of a specialized company in foreign trade management to overcome this challenge.

In addition to logistical issues, there are several stages involved in the process for obtaining an export license, a common complaint among importers regarding products regulated by Anvisa. Many fields must be correctly filled out, in addition to the registration of the Import License in Siscomex, among other procedures (which will be shown later in the content).

There are also some documents that must necessarily be attached to the Siscomex Single Portal, such as:

• extract of the Import License (LI);
• proof of sterility of the product, for sterile products;
• Commercial Invoice – “Invoice” (original signed copy);
• Bill of Lading (original signed copy);
• Single Import Declaration (DUIMP);
• Declaration of the Holder of the Registration (DDR) – required for imported products when the importer is not the holder of the regularization of the merchandise.

To deal with these challenges and peculiarities, it is crucial that the importer has a deep understanding of the rules for importing products regulated by Anvisa.

How are products regulated by Anvisa imported?

Now that you have a more comprehensive understanding of the rules for importing products regulated by Anvisa, we will show you a step-by-step guide on how this procedure should be carried out.

To import products regulated by the agency, it is necessary to register the Import License (LI) together with Siscomex Importação, and then create a dossier in the Integrated Vision system.

After that, the entrepreneur must use the specific subject code to attach the Primary Petition to the document, also attaching all relevant documentation to the process, according to importation legislation. Then, you need to link the dossier to a single import license.

Then, it will be necessary to wait a period of at least 30 minutes for the data to be processed and there is communication between the PEI and Integrated Vision systems. Anvisa’s petition will be sent to the importer’s mailbox in the system.

After opening the message, you need to click on “Complete Petition,” fill in your information in the Electronic Petition Form, and finally click on the indicated command to generate the Unique Collection Guide (GRU). After making the payment of the GRU, it will be necessary to wait until the bank clearing occurs, unless it is the case of a fee-free GRU.

Finally, the importer will receive a message in their mailbox (from Anvisa’s petitioning system) informing that the bank compensation has occurred, through a document called Proof of Protocolization.

As you can see, there are several rules for importing products regulated by Anvisa, aimed at protecting the health and safety of the population, preventing dangerous goods from entering our country without proper inspections. 

Would you like to deepen your knowledge about importing? Then, read our article on DUIMP and learn more about the new single import declaration.