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What is the SNVS?
Brazil’s National Health Surveillance System (SNVS) provides a comprehensive framework for monitoring and regulating health products and services. It is coordinated by the Agência Nacional de Vigilância Sanitária (ANVISA), which is the Brazilian Health Regulatory Agency, and it includes the Ministry of Health and Health Surveillance Centers of the States, Territories, and the Federal District.
SNVS has several key components and tasks, including:
- Post-market Surveillance (PMS)
- Registration holders must designate a professional for PMS and implement a risk management system for their products.
- They must notify the SNVS of all malfunctions, adverse events, and other serious threats to public health within the specified timeframes.
- Mandatory Notification
- Registration holders must notify the SNVS of certain events, such as deaths, serious threats to public health, and counterfeiting, within the specified deadlines.[i]
- Coordination and Oversight
- ANVISA is responsible for coordinating the SNVS and ensuring the sanitary control of products and services throughout the national territory.
- The agency oversees the approval and supervision of various health-related products and services, including food, cosmetics, pharmaceuticals, and medical devices.
- Historical Development
- The SNVS has its roots in the National Epidemiological Surveillance System (NESS), which was established in the 1970s and transformed into the Health Surveillance Secretariat of the Health Ministry (HSS/HM) in 2003.
- Regulatory Functions
- ANVISA aims to preserve public health by regulating the manufacturing, marketing, and usage of health-related products and services.
The SNVS plays a vital role in ensuring the safety and efficacy of health products and services in Brazil through rigorous monitoring and regulation. Its comprehensive framework, spearheaded by ANVISA, upholds public health standards across the nation.
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