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.
Some of the most important regulations for medical devices in Brazil are:
- Labeling - 21 CFR Part 801
- RDC No. 24 of 21 May 2009 - Registration application process (English)
- RDC No. 185 of 22 October 2001 - Medical Device Classification Rules, Technical File Requirements (English)
- Decree 8077 - 14 August 2013 - Regulating the Registration, Control, and Monitoring of Medical Devices (English)
A full list of ANVISA regulations can be found here.
Medical Device Associations in Brazil:
- Associação Brasileira dos Importadores de Equipamentos, Produtos e Suprimentos Médico-Hospitalares (ABIMED)
- Sociedade Brasileira de Biotecnologia (SBBiotec)
- Brazilian Association of Medical Devices Manufacturers (ABIMO) & Union of the Industry of Dental, Medical and Hospital Articles and Equipment (SINAEMO)