ANVISA – Medical Device Registration and Approval in Brazil

Submitted ANVISA Brazil RegistrationsMedical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA). Brazil’s base regulations and medical device classification schemes are similar to those found in the European MDD 93/42/EEC.

Cadastro vs. Registro (`Registration Routers)

The first step in the Brazil regulatory process is to determine the correct classification of your medical device. Lower risk Class I and II devices will follow the Cadastro registration route, which includes a simplified application. Higher risk Classs III and IV devices must follow the Registro registration process.
If your device is Class I or II, you must submit an application and legal documents to ANVISA for review and approval, Class I and II device manufacturers must also compile a comprehensive technical dossier for their BRH to keep on file, along with proposed labeling and IFU, in case of an ANVISA audit.

Class III and IV device manufacturers must prepare a Technical File including clinical data, clinical studies, and additional device information in accordance with Annex III Part A, B or C of RDC 185/01 and submit to ANVISA. Legal documents, IFUs, and proposed labeling are also included in the Technical File.