Foreign companies wishing to sell in Brazil are required to have a local establishment/partner who will act as their in-country representative with ANVISA.
The local partner holds the ANVISA approval on behalf of the company and controls all import/export/sales of the product.
This approval is non transferable from one partner to another, even if both parties agree to it and hold all required permits. Therefore, the decision on which Brazilian partner to collaborate with
can be crucial.
Companies entering the Brazilian market should carefully asses their opportunities and threats, strengths and weaknesses and form a strategic plan that will be the foundation to all their decision making processes.
There are 3 main channels for a company to enter Brazil as seen below.
Each method has its pros and cons and should be carefully evaluated
according to the company's business models, targets, budget etc.