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Regulatory Affairs - ANVISA

The regulatory process in Brazil is different from that of the USA and some European countries, because different government agencies are involved.


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Health-related companies that wish to sell products in Brazil must register with the Brazilian Health Regulatory Agency, or ANVISA (in Portuguese). This agency is equivalent to the FDA in the United States, and regulates a variety of products and services related to health. RAGB provides these companies with advisory and consultancy services to help them stay in compliance with ANVISA regulations.

RAGB’s highly qualified and well-trained technical staff provides a wide range of services. We can help make communication between your company and ANVISA more timely and effective. We can assist you with regulatory requirements such as Health Surveillance Business Licenses and Business Operation Authorizations. We can handle certification, product regulation, auditing, and advise you on best practices to do health-related businesses in Brazil.

Our company will guide you through the complex regulatory process in Brazil, making it easier for your company to sell your products. The services we provide include ANVISA international audits, serving as a Brazilian Registration Hosting Service, and follow-up throughout the entire ANVISA certification process.

The Ministry of Agriculture, Livestock and Supply (MAPA) regulates products of animal, mineral and plant origin, beverages, agricultural products, veterinary products, food additives, and animal grooming products. Click here for the full list of products.  

Products under ANVISA regulation
Health products (health-related products, known as correlatos, in Brazil): health supplies and equipment, in vitro diagnostic devices.
Cosmetics, personal hygiene products and perfume.
Sanitizers and household products.
Food: new food, food claiming to have functional and/or health properties, and supplements.
Drugs: original, similar and generic.

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