Registration in Brazil

CMC Medical Devices provides registration services for medical devices and IVD products in Brazil, supporting your entry into the Brazilian market while ensuring compliance with ANVISA regulatory requirements. Brazil’s medical device framework covers risk classification, notification or registration, and requires local responsible representation.

CMC can prepare and submit your registration dossier to ANVISA, act as your Brazilian Registration Holder (BRH) or local authorized representative, and guide you through risk classification, labeling in Portuguese, documentation requirements, and communications with authorities. CMC can also assist with HS Free Sale Certificate (FSC) and other documents commonly requested for ANVISA applications.

With CMC, you can introduce your products to the Brazilian market confidently and in compliance with local regulations.