A foreign company cannot obtain a product registration from Anvisa on its own: regularization is held by a company incorporated in Brazil, according to the set of rules and Anvisa's guidance. Grupo Soluto has four companies for these fronts; below, who answers for each one.
The order is that of the group's journey. It is not a requirement to hire all four companies.
Regulatory Strategy
Marketing Authorization Holder & Compliance
Technology & Automation
Market Access
Each point gives the statement, its limit and the official source.
No single article says that a foreign company cannot register a product. The opening sentence is a synthesis, according to the set of rules and Anvisa's guidance cited below.
Go to a point
Anvisa states that only companies legally incorporated in Brazilian territory can apply for an Operating Authorization (Autorização de Funcionamento).
Limit of this statement: The guidance comes from a 2021 Anvisa page, now reachable only as an archived copy. It covers the Operating Authorization, not each type of product.
For a foreign company, Anvisa says a commercial agreement with a company in Brazil is required. That company does not have to be a branch: it can be just an importer, which takes on the foreign company's technical and legal responsibility in Brazilian territory.
Limit of this statement: This is the same archived 2021 page. The agreement is not described in an article of any rule.
In the medical device rule, the holder of the notification or registration is the legal entity, manufacturer or importer, responsible for the device in national territory and holding the marketing concession issued by Anvisa. In technovigilance, the registration holder is the legal party responsible for the product.
Limit of this statement: The definitions come from the medical device and technovigilance rules. Medicines, cosmetics and sanitizing products follow their own rules.
A notification or registration request for a medical device includes a declaration from the legal manufacturer authorizing the applicant company to represent it and to sell its products in Brazil.
Limit of this statement: It applies to medical devices. Other categories have their own requirements.
The Operating Authorization (AFE) is required of each company that manufactures, imports, stores, distributes or transports medicines, pharmaceutical inputs, cosmetics, hygiene products, perfumes and sanitizing products. For health products, it is required of each establishment. Food has no AFE from Anvisa: the establishment is licensed by the state, district or municipal health authority.
Limit of this statement: The rule lists more activities than those cited here.
Under Law 6,360, the products it covers, including imported ones, cannot be manufactured, displayed for sale or delivered for consumption before being registered with the Ministry of Health.
Limit of this statement: It applies to the products Law 6,360 regulates. Products under notification or communication follow the rule of their own regulation.
The import license at Anvisa is requested by companies registered with Anvisa and enabled in Siscomex. A company that imports in order to sell must ask for its AFE to be extended to the distribution activity.
Limit of this statement: This is Anvisa's description of the service. The full procedure is on the service page.
The single channel receives the request and takes it to the right company.
