One of the factors that determines that foreign companies give up starting a business in Brazil is the bureaucracy. Besides not knowing how to interpret the current legislation, the lack of knowledge or even non-compliance with them cause a greater problem when regulating the company in Brazil, so it is very relevant to receive proper advice. We will help you with the regularization of your company in Brazil.
Today in this content we will talk about what is necessary to start a business in Brazil following the laws imposed by Anvisa. Anvisa - National Health Surveillance Agency is the agency responsible for the sanitary control of products and services in order to promote the protection of human health.
To start a business in Brazil, as anywhere, it is initially necessary to obtain a physical location, it means, the place where your establishment will be. With the defined location it is possible to start the construction or renovation of the environment that will serve as: Factory, distributor, importer or warehouse.
To perform any of the above activities you must be within the legality of Anvisa, for this the company will need to obtain its operating license, operating authorization and of course register each product correctly.
Operating License: The operating license is the first step to start a business in Brazil, this initial process is carried out by Visa - Sanitary Surveillance of the municipality where will be the headquarters of your business. For each municipality there is a VISA that attend local requests, different from ANVISA, which acts in a broader scope governing norms and rules that must be followed by VISA.
To obtain the Local Operating License it is important that your establishment complies with a series of rules that dictate from the finishing of the floor to the number of sinks that the local must contain, besides, the establishment will need some more documents like the Technical Report that is known in Brazil as LTA, Fire Department Inspection Certificate - AVCB and others. VISA will conduct an inspection to verify compliances and non-compliances, if everything agrees, the operating license will be issued. Another process will be initiated for the petition of the Operating Authorization.
Operation Permits: The ready petition processes are filed directly in Brasilia as this documentation is evaluated directly by Anvisa. Along with the documentation is the collection of fees, submission of tests and others.
Product Registration: After the company is regularized it is possible to register products, products in Brazil are subject to: Notification, cadaster, registration or are exempt. This selection is made based on the risk classification of each product, which ranges from I to IV, evidently being I the lowest risk class and IV the highest.
Companies with products with a risk rating higher than III must have Good Manufacturing Practices Certificate: this is a set of standards and rules that include all processes involving the product.
For Product Registration, Anvisa requires information about the product, such as labeling, instructions for use, disposal instructions if necessary, as well as tests that prove the efficacy and safety of each product, among others.
You can only market your products in Brazil after all these steps are completed. These processes are already complicated enough for Brazilians themselves, for those who are completely unaware of them the difficulty is even greater. For this, Stone Okamont offers its consulting service, advising at each stage and intermediating between client and regulatory agency.
Thinking about the costs of all the implementation of companies in Brazil we offer a second option that has the Holder services. This works as follows: Our company is ready with all necessary regularization: License and Authorization and we can host your products, requiring only registration with Anvisa for marketing in Brazil, so you can also be free to choose your distributor and how many distributors you want to keep.
Stone Okamont is always ready to serve you better and provide practical and creative solutions to your problems.
Contact us! Fill out the form below, talk to one of our professionals and get all your questions about how starting a business in Brazil and Holder services.
