ANVISA - Brazil National Health Surveillance Agency

The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services and, among others, medical devices. The agency is connected to the Ministry of Health, that manages it through a management contract signed periodically.

Established in January 26, 1999, the agency is administratively and financially independent, being managed by a 5-member board of directors. The ANVISA department dealing with medical devices is the General Office of Medical Devices Technology.

Major Regulations

Some of the most important regulations for medical devices in Brazil are:

A full list of ANVISA regulations can be found here.

Contact details:

Medical Device Associations in Brazil: