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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.
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.
All companies that work in the regulated areas shown below must obtain this permit in Brazil.
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
Manufacturing
Distribution
Imports
Exports
Storage
Transportation
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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