After obtaining the State Operating License, next step for many companies and obtaining the Company Operating Authorization (AFE) Anvisa.

Health-related companies that wish to sell products in Brazil must 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 Company Operation Authorizacion from ANVISA.

Who Needs an (AFE)?

All companies operating in the regulated areas presented below must obtain this Authorization 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 (AFE) Authorization to Operate a Company

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.

Services We Offer

A highlight of RAGB’s foreign company services is the Enterprise Qualification Program, which is responsible for preparing professionals according to demands from governmental agencies.

We are qualified to develop pre-audit plans, give advice on nonconformity management, conduct employee training, and more, preparing companies to be internationally audited by ANVISA.

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