Brazilian Health Regulatory Agency (ANVISA)

What is ANVISA? The Brazilian Health Regulatory Agency, known as ANVISA (Agência Nacional de Vigilância Sanitária), is Brazil’s national authority responsible for regulating a range of health products. Its jurisdiction covers medical devices, in vitro diagnostic (IVD) devices, active pharmaceutical ingredients, drugs, food and beverages, cosmetics, personal care products, sanitizing agents, and pesticides. ANVISA also oversees blood, tissue, organs, and transplants, as well as tobacco products. The agency issues resolutions, technical regulations, and guidance documents that articulate regulatory requirements for products under its purview. It was established in 1999 and operates under the Ministry of Health. What does ANVISA do? ANVISA carries out a range of activities to ensure that products on the Brazilian market meet safety and quality requirements throughout their life cycle. This includes pre-market registration, where the agency evaluates technical documentation and grants market authorization for regulated products. It also oversees Good Manufacturing Practices (BGMP) by inspecting manufacturers in Brazil and abroad to verify compliance with Brazilian requirements. Once products are on the market, ANVISA monitors adverse events, product recalls, and safety alerts for regulated products. In addition, the agency works with customs to oversee the import, export, and transport of health-related goods through Brazilian ports of entry.