Brazil ANVISA Registration

In Brazil, the approval from the Agencia Nacional de Vigilancia Sanitaria (ANVISA) is required before any medical device can be sold in Brazil.To obtained the approval, registration (Registro) is required for all Class III and Class IV medical devices, and notification (Cadastro) is required for Class I and II medical devices.

In addition, for Class III and IV products, a factory inspection by ANVISA is required before registration application, to ensure that the quality management system of the factory comply with Brazilian Good Manufacturing Practices (BGMP). Moreover, InMetro certification is required for some designated medical devices as a precondition to registration application.

Our Services：

Application strategy consulting

Determine product classificationand application pathway

Testing service

Develop regulatory compliance solutions

Compile application documents

Medical device license holder service