Brazilian Registration Holder

The Brazilian legislation establishes that only national companies are able to register medical devices, and these companies must have local and federal sanitary licenses. The BRH is responsible for your device registration in Brazil and acts as a link between your company and ANVISA.

Appointing an independent ANVISA representative gives you more flexibility and control over your registration than appointing a distributor for that role. Brazilian legislation allows the registration holder to give import permits authorizing the distributor(s) of your choice to import your devices, which means you will have full control of your registration.

DOMO Salute meets both legal and technical requirements to host medical devices registries, acting as your in-country representative before ANVISA and taking care of all regulatory procedures. As a legal representative, our services scope includes registration control, surveillance and adverse event reporting. DOMO Salute acts in the best interest of your company in Brazil.

Having DOMO as your BRH also means there’s no need to choose a distributor beforehand: you can start your registration process while learning about the Brazilian market and getting to know the distributors. It is important to choose your BRH carefully.