ANVISA
Agência Nacional de Vigilância Sanitária
ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian Health Regulatory Agency responsible for health product regulation, including medical devices, pharmaceuticals, and food safety.
Complete Guide to ANVISA
ANVISA (Agência Nacional de Vigilância Sanitária), translated as the National Health Surveillance Agency, is Brazil's regulatory authority responsible for protecting public health through the control and oversight of products and services subject to health surveillance.
ANVISA's responsibilities include:
- Medical device registration and post-market surveillance
- Pharmaceutical regulation and drug approval
- Food safety and cosmetics regulation
- Blood products and health services oversight
Medical device classification in Brazil:
- Class I - Low risk (self-declaration)
- Class II - Medium-low risk (Cadastro)
- Class III - Medium-high risk (Registro)
- Class IV - High risk (Registro with clinical data)
Key requirements for foreign manufacturers:
- Must appoint a Brazilian Registration Holder (BRH)
- Products must be registered in ANVISA's database
- Good Manufacturing Practice (GMP) certification required
- Portuguese labeling and instructions for use
Registration timeline: Typically 6-12 months depending on device class.
ANVISA is considered one of the more stringent regulatory agencies in Latin America and is often used as a reference by other LATAM countries.
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