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.
All companies operating in the regulated areas presented below must obtain this Authorization in Brazil.
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.
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.
Need to Register Software on Anvisa? Today the RAGB tells you everything you need to know about it. With this guide y...See More