ANVISA registration: a guide to compliance for foreign businesses
A practical overview of Brazil’s health surveillance framework, the company and product authorisations foreign businesses need before they can sell into Brazil, and the main compliance obligations that follow.
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ANVISA regulates a wide range of products, and a foreign business cannot obtain most authorisations directly.
The National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) is the federal agency responsible for the sanitary control of medicines, medical devices, cosmetics, sanitisers, food and a number of other product categories, as well as the ports, airports and borders through which they enter the country. It was created by Law 9,782/1999 as an autonomous agency linked to the Ministry of Health.
Two authorisations sit at the centre of almost every foreign business’s route to the Brazilian market: a company-level authorisation to operate (for most product categories, the Autorização de Funcionamento, AFE), and a product-level authorisation to sell (either full registration, Registro, or the lighter-touch notification, Cadastro or Notificação, depending on the product’s risk classification). A foreign manufacturer cannot hold either directly and must act through a Brazilian legal entity. This guide explains how the system fits together and what a foreign business needs to plan for.
The regulatory framework
ANVISA’s authority rests on a small number of foundational statutes, supplemented by product-specific resolutions (Resoluções da Diretoria Colegiada, RDCs) that ANVISA updates far more frequently than the underlying laws.
Law 6,360/1976 is the foundational statute for medicines, medical devices, cosmetics, personal hygiene products, perfumes and sanitisers, requiring that these products be registered before they can be manufactured, imported or sold, and that the marketed product correspond exactly to what was authorised.
Law 9,782/1999 created ANVISA and the National Health Surveillance System (Sistema Nacional de Vigilância Sanitária, SNVS), a coordinated structure of federal, state and municipal health surveillance authorities. It also defines the exemptions from pre-market approval under its article 41, for product categories considered lower-risk.
Law 6,437/1977 sets out the sanitary infractions and penalties (warning, product seizure, suspension of sale, cancellation of the authorisation or licence, and fines) that apply where a company operates, or a product is marketed, without the required authorisation.
Beneath these statutes sits a large body of RDCs, each governing a specific product category or process (for example RDC 16/2014 for company authorisation, RDC 751/2022 for medical devices, RDC 830/2023 for in vitro diagnostics). RDCs are revised often, so the specific resolution applicable to a product should always be checked against ANVISA’s current index before a submission is prepared.
The AFE and the federal product registration are issued by ANVISA and apply nationally. Separately, most establishments also need a state or municipal sanitary licence (licença sanitária or alvará) to operate physically at a given address, issued by the local health surveillance authority (vigilância sanitária). The two are complementary: holding an AFE does not remove the need for a local licence, and vice versa.
Registration or notification: it depends on risk
ANVISA does not require full pre-market registration for every regulated product. Under article 41 of Law 9,782/1999, categories considered lower-risk are exempt from registration, and some of those instead go through a simplified notification pathway that involves no substantive review by the agency. Higher-risk categories require full registration (Registro), with a technical dossier and, in most cases, an ANVISA review of the manufacturing site’s compliance with Good Manufacturing Practices.
A notified product still requires a Brazilian company holding an AFE (where applicable), Portuguese-language labelling that meets ANVISA’s requirements, a complete technical file kept on record, and full exposure to inspection and post-market enforcement. The difference from full registration is that ANVISA does not substantively review the file before the product reaches the market, not that no rules apply.
Medical devices: RDC 751/2022 and the four risk classes
RDC 751/2022, in force since 1 March 2023, is the principal regulation for medical devices, replacing the previous RDC 185/2001 and RDC 40/2015. It aligned Brazil’s classification rules more closely with the EU MDR and the IMDRF framework. In vitro diagnostics are carved out and separately governed by RDC 830/2023.
A foreign medical device manufacturer without a physical presence in Brazil must appoint a Brazilian legal entity as its BRH, holding a valid AFE, to submit the notification or registration, appear on the product’s labelling, and take on regulatory responsibility, including post-market surveillance and any ANVISA inspection of the manufacturing site, once the product is on the market. Transferring a registration to a different BRH later requires the outgoing holder’s cooperation and can take several months, so the choice of BRH is a significant commercial decision, not a formality.
Medicines: dossier review, GMP and priority classification
Registration of medicines is the most demanding pathway ANVISA operates, reflecting the underlying safety, efficacy and quality review the agency must complete before a medicine can be marketed in Brazil. Active pharmaceutical ingredients may also require separate regulatory treatment, including the DIFA/CADIFA procedures applicable to relevant APIs, which follow their own process distinct from finished-medicine registration.
As with medical devices, the registration must be held by a Brazilian entity holding the relevant AFE, commonly the local subsidiary, importer, or a licensed partner acting as the regulatory affairs holder for the product, who becomes ANVISA’s point of contact for the life of the registration.
Cosmetics, sanitisers and food: lighter obligations, still federal rules
These categories carry a lower registration burden than medicines or higher-class devices, but each has its own rules on labelling, composition and, for cosmetics and sanitisers, a company-level AFE.
Practical steps: bringing a regulated product to Brazil
A high-level sequence most foreign businesses will follow, adapted to the specific product category and risk class involved.
Key risks and practical points
A number of issues arise frequently for foreign businesses navigating ANVISA compliance and are worth understanding before committing to a market entry timetable.
ANVISA publishes statutory maximum review periods for some processes, but actual timing depends heavily on dossier quality, the specific product category, and the agency’s current workload, which has fluctuated significantly in recent years. Businesses planning a Brazilian launch date should build in meaningful contingency.
Need advice on your ANVISA compliance strategy?
The right pathway, company structure and local partner depend heavily on the specific product and category involved. Contact us for advice tailored to your product and entry strategy for Brazil.
This page is a summary only and does not constitute legal advice.
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