anvisa

Anvisa, officially the National Health Surveillance Agency, is a Brazilian federal regulatory agency responsible for health surveillance. Created in 1999, it operates within the executive branch and is linked to the Ministry of Health. Its mission is to protect and promote public health by regulating, standardizing, and supervising products and services that have a direct or potential impact on health.

Scope and functions: Anvisa regulates medicines, vaccines, and other health products; medical devices; cosmetics; food and dietary supplements; tobacco products; and health services such as hospitals and clinics. It also regulates clinical trials, advertising and labeling of regulated products, and the import and export of regulated items. The agency conducts conformity assessments, issues registrations or approvals, performs inspections, and conducts post-market surveillance and recalls when necessary, applying sanctions when violations occur.

Organization: The agency is headquartered in Brasília and operates with regional units and partnerships with state health surveillance secretariats and municipalities. It is governed by a Director-President and a collegial board, and organized into directorates focused on different product areas and on regulatory science and risk assessment.

International role: Anvisa represents Brazil in international health regulation discussions and collaborates with organizations such as the World Health Organization and the Pan American Health Organization, engaging in technical cooperation, harmonization of standards, and information sharing.

Impact: As a central component of Brazil's health governance, Anvisa helps ensure the safety, efficacy, and quality of health products on the Brazilian market and supports public health responses through regulatory science and surveillance.