The National Health Surveillance Agency (ANVISA) was established by Law 9.782, of January 26, 1999. The Agency is designated an autonomous agncy operating under a special regime. This means that ANVISA is an independently administered, financially-autonomous regulatory agency, with security of tenure for its directors during the period of their mandates. The Agency is managed by a Collegiate Board of Directors, comprised of five members.

Within the structure of Federal Public Administration, the Agency is linked to the Ministry of Health, under a Management Contract. The agency incorporated additional attributions: coordination of the National Sanitary Surveillance System (SNVS), the National Program of Blood and Blood Products and the National Program of Prevention and Control of Hospital Infections; monitoring of drug prices and prices of medical devices; attributions pertaining to regulation, control and inspection of smoking products; technical support in granting of patents by the National Institute of Industrial Property.

          The institutional purpose of the agency is to foster protection of the health of the population by exercising sanitary control over production and marketing of products and services subject to sanitary surveillance. The latter embraces premises and manufacturing processes, as well as the range of inputs and technologies concerned with the same. In addition, the Agency exercises control over ports, airports and borders and also liaises with the Brazilian Ministry of Foreign Affairs and foreign institutions over matters concerning international aspects of sanitary surveillance.