ABSTRACT
On December 31, 1998, the Brazilian President signed a Provisional Measure #1791, which created the Agência Nacional de Vigilância Sanitária (Brazilian National Health Vigilance Agency) or the ANVISA. The ANVISA replaced the National Secretary of Sanitary Vigilance (SVS), which was established in 1975 under Public Law #6360. The ANVISA has enforcement powers similar to the US Food and Drug Administration (FDA) that enable it to regulate the manufacture, import, and distribution of pharmaceuticals and medical devices. The ANVISA was created as a public company under contract to the Ministry of Health. The ANVISA Director is nominated by the President of Brazil and serves a five-year term. The law provides for a formal separation between the ANVISA, which is responsible for all sanitary and health inspection, and the Ministry of Health, which is responsible for public policy related to health issues.
