WHAT WE DO

ANVISA Medical Device Registration in Brazil

Brazil is the largest medical device Market in Latin America, and it has a well-established but rather complex regulatory system. Before marketing medical devices in Brazil the products must comply with ANVISA`s (Brazilian Health Surveillance Agency) requirements.

 

The application and regulatory requirements vary depending on the device`s classification. As such, the correct classification of your device is essential.

 

NOTIFICATION: The registration of class I devices is achieved through a simplified process, without the need of a technical evaluation from the Agency. A technical dossier of the product as well as the proposed Portuguese label and instructions for use must be maintained by the registration holder. Class I registration does not expire.

 

CADASTRO: Devices classified as Class II must comply with a simplified registration process which is technically evaluated by ANVISA prior to its approval. A technical  dossier of the product as well as the proposed Portuguese label and instructions for use must be maintained by the registration holder. Class II registration does not expire.

 

REGISTRO: Devices classified as class III and IV must take a regulatory route, which requires a BGMP certification prior to the product’s registration. The process includes a complete technical file containing clinical data, biocompatibility studies, performance tests, among other devices’ information. Legal documents, proposed Portuguese label and instructions for use must also be included in the technical file. Class III and IV registrations are valid for ten years.

 

DOMO Salute has the knowledge and expertise to work out the correct classification for your device (medical devices, in vitro diagnostics, combination products, software as medical device and health and wellness products) and to assist with every step of the preparation and submission of your application. To take the appropriate time to understand your product means that from the beginning you will know exactly the paths your product will take and the total cost of the project.

 

Additional certifications (INMETRO/ ANATEL) might be needed depending on the features of your device. DOMO Salute can support you on the certification process. For more information please check here.

 

An in-country regulatory representative company (Brazilian Registration Holder) will be needed if your company does not have a legalized and authorized Brazilian office. DOMO Salute can host your registries. For more information please check here.

Learn more about the Brazilian regulatory process by getting an exclusive overview of the process