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FDA Law in Brazil refers to the complex set of legal norms, regulations, and procedures related to the control of food, pharmaceuticals, medical devices, cosmetics, and other products impacting public health. Unlike the United States, Brazil does not have an “FDA” but its counterpart is the Agência Nacional de Vigilância Sanitária (ANVISA) - the Brazilian Health Regulatory Agency. ANVISA enforces health and sanitary regulations to ensure that products are safe for human use and consumption within Brazil. Brazilian FDA Law covers product registration, labeling, clinical trials, marketing authorization, import and export control, inspections, recalls, and other compliance measures.
Navigating FDA Law in Brazil can be complicated due to the technicalities, language barrier, and frequent regulatory changes. Common situations where legal help may be essential include:
Having an experienced lawyer ensures you comply with all legal requirements, prevent costly errors, and efficiently resolve any disputes involving FDA-regulated products in Brazil.
Some of the most important aspects of Brazilian FDA Law include:
Understanding these requirements is vital for safe and lawful operation within the Brazilian health products market.
ANVISA is Brazil’s national health surveillance agency responsible for regulating health products, similar to the FDA in the United States. ANVISA operates under specific Brazilian laws and procedures, which may differ significantly from US federal regulations.
Any person or company intending to import, manufacture, market, or distribute regulated products such as food, drugs, cosmetics, or medical devices in Brazil must complete the appropriate registration process with ANVISA.
Documentation typically includes technical files, safety and efficacy studies, manufacturing information, product labeling, certificates of Good Manufacturing Practice, and proof of payment of applicable fees.
The timeline can vary widely depending on the product category and completeness of the submission. It can take from six months to over a year for pharmaceuticals or novel medical devices, while simpler products may be processed faster.
Yes, foreign manufacturers must appoint a legal representative or “local agent” based in Brazil to liaise with ANVISA, handle regulatory submissions, receive notifications, and represent the company in case of compliance issues.
Inspections involve review of facilities, production practices, documentation, and compliance with sanitary regulations. Failure to comply may result in penalties, suspension, or product recalls.
Yes, all product labeling, instructions, and regulatory submissions must be in Portuguese, Brazil’s official language.
No. Marketing regulated health products without ANVISA approval is illegal and can result in significant sanctions, including product seizure and heavy fines.
If a product is found to present health risks, companies must notify ANVISA and start a recall process according to agency guidelines, ensuring public notification and tracking of affected lots.
Foreign clinical trial data may sometimes be accepted, but Brazilian authorities often require local trials or additional evidence to confirm safety and efficacy for the local population. Approval is case-specific.
If you need more information or assistance regarding FDA Law in Brazil, consider consulting:
If you require legal assistance or guidance with FDA Law in Brazil, consider the following actions:
Starting early and involving a legal professional with experience in Brazilian FDA Law can save time, prevent regulatory setbacks, and help you successfully achieve your business objectives.
