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 medical devices, among others. The agency is connected to the Ministry of Health, which manages ANVISA 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 General Office of Medical Devices Technology is the ANVISA department that deals with medical devices.
A list of ANVISA regulations can be found here on our website.
Contact details:
Medical Device Associations in Brazil:
- Associação Brasileira dos Importadores de Equipamentos, Produtos e Suprimentos Médico-Hospitalares (ABIMED)
- Brazilian Association of Medical Devices Manufacturers (ABIMO) & Union of the Industry of Dental, Medical and Hospital Articles and Equipment (SINAEMO)
Related services for Brazil:
- Brazil ANVISA Medical Device Registration Holder
- Brazil GMP (B-GMP) Quality System Consulting - RDC 59, RDC 25, RDC 16
- Brazil INMETRO Testing Certification for Medical Devices
- Brazil Medical Device Approval & ANVISA Registration
- Brazilian Medical Device Classification by ANVISA
- Vigilance Reporting for Medical Device Manufacturers in Brazil