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ANVISA Operating Permit (AFE)

Autorização de Funcionamento Empresa(AFE) ANVISA. Autorização de Funcionamento Empresa(AFE) ANVISA.

After obtaining an operating license, the next step for any health-related company that wants to sell their products in Brazil is to obtain an Operating Permit (AFE) from ANVISA.


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RAGB guides your company throughout the entire process of obtaining this permit. We assist you with the filing of all documents and receiving feedback from this government agency. Thus, should ANVISA come up with any questions or demands during the process, we will be able to respond promptly and communicate with you. By providing these services, we allow your company to optimize time and reduce costs.

Who Needs an Operating Permit?

All companies that work in the regulated areas shown below must obtain this permit in Brazil.

Main Areas

Health products (health-related products, known as correlatos in Brazil)

Cosmetics, personal hygiene products, and perfume

Sanitizers and household products

Food products

Drugs

In vitro diagnostics

Main Activities

Manufacturing

Distribution

Imports

Exports

Storage

Transportation

Process to Obtain the Operating Permit

The process to obtain this permit involves putting together various documents to be submitted to ANVISA’s auditors and inspectors. These agents validate the documents and issue the permit, which is then published in the Brazilian Official Gazette, the government publication that contains notification of new legislation, decrees, and other subjects related to public administration.

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