Created by the Law No. 9.782, of January 26th, 1999, the National Sanitary Surveillance Agency (ANVISA) is an autarchy under special regime, which has as area of operation every sector related to products and services that may affect the health of the Brazilian population. Its responsibility is to ensure the sanitary control of ports, airports and borders, as well as the protection to the health of the traveler, of the means of transportation and the services submitted to the sanitary surveillance. Besides the regulatory assignment, it is also responsible for the coordination of the National Sanitary Surveillance System (SNVS), in an integrated manner with other public bodies directly or indirectly related to the health sector.
ANVISA is bound to the Ministry of Health and is part of the Single Health System (SUS).
Private act of the relevant body of the Ministry of Health, responsible for the Sanitary Surveillance of the products referred to in Decree No. 79.094/77, containing permission for the companies to operate the activities under the Sanitary Surveillance regime, instituted by Law No. 6.360/76 upon proof of specific technical and administrative requirements. The (AFE) Authorization will enable the Company to work in all national territory and will have to be renewed when an Alteration or Change of Activity covered in the scope of the Decree No. 79.094/77, or change of the Partner, Director or Manager that has on his position the legal representation occurs.
ANVISA will publish in the Official Federal Gazette the Operation Authorization Assignments (AFE), its Amendments and Cancellation. The companies may only perform their activities after the Operation License, assigned by the State or Federal District or Municipal Sanitary Surveillance Body.
AFE Certificate (Company Operation Authorization) is a document that proves that the company is authorized to perform its activities described in the certificate, besides containing the number of the company's authorization and address.
For the operation of the companies that intend to perform activities of extraction, production, manufacture, transformation, synthesize, packaging, re-packaging, import, export, storage, shipping, transporting, contained in Law No. 6.360/76, Decree No. 79.094/77 and Law No. 9.782/99, Decree No. 3.029/99, correlated to Household Sanitization Products needs ANVISA Authorization, body bound to the Ministry of Health.