Product Registrations - Anvisa

All medical devices subject to the Health Surveillance regime must, according to their risk class, be approved by Anvisa before being marketed.

Class III and IV Medical Devices must be registered with Anvisa. The registration process consists of submitting a technical dossier that will be analyzed by Anvisa, which will give its technical opinion based on the documents presented.

Therefore, preparing a technical dossier in compliance with current legislation is of fundamental importance for the success and approval of your product.

Our services consist of, among other activities,:

• Initial analysis of legal and technical documents;

• Preparation of the technical dossier in accordance with current legislation;

• Protocol with Anvisa;

• Monitoring the process with Anvisa;

• Compliance with technical requirements (when applicable);

• Monitoring of publications in the Official Gazette of the Union;

• Appeals against Rejections (when applicable);

• And other activities arising from regulatory matters of your company;

Don't let Anvisa's bureaucracy prevent your company's success.

Brasil Regulatórios is the key to your company's regulatory success.