All medical devices subject to the Class I and II Health Surveillance regime are subject to Notifications with Anvisa.

Brasil Regulatórios has vast experience in preparing Notification processes and we offer our knowledge to define the best regulatory strategy for your company.

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.