To apply for Class III medical device registration with Brazil's ANVISA, you will need to submit your application through ANVISA’s electronic system known as Solicita. This system is used for managing all medical device registrations, including for Class III devices. Below is an overview of the application process and where to apply:

1. Access the ANVISA Solicita System

• The Solicita system is the official online platform for submitting medical device registration applications to ANVISA.
• You can access the Solicita system via ANVISA's official website:
  ANVISA Official Website
• Solicita Link: Once on the website, navigate to the appropriate section for medical device registration.

2. Create an Account and Log In

• Before submitting your application, you must create an account on the ANVISA e-Services platform.
• Only authorized entities (e.g., the Brazilian Registration Holder) can submit the application, so if you’re a foreign manufacturer, your Brazilian Registration Holder (BRH) must handle this process.

3. Submit the Application

• Once logged in, your BRH will submit the technical dossier for the Class III device, which includes:
  • Clinical data
  • Risk management documentation
  • Quality management system compliance
  • Manufacturing information (including GMP certification)
  • Labels and instructions for use (in Portuguese)
• The application is submitted electronically through the Solicita portal, and the platform allows users to track the status of their submission.

4. Pay the Required Fees

• As part of the submission process, the appropriate registration fees (as determined by ANVISA) must be paid. The payment can typically be done via the platform.

5. Follow Up with ANVISA

• After submission, ANVISA may request additional information or documents. You can track the progress of the application and any requests for further documentation directly in the Solicita system.

6. Monitor Approval Process

• ANVISA’s review process for Class III devices is generally lengthy, taking anywhere from 12 to 18 months. Once approved, the registration certificate will be issued.

Additional Points:

• Required Documentation: Ensure all documents are in Portuguese, including the technical dossier and any supplementary data like clinical studies and GMP certification.
• Brazilian Registration Holder (BRH): Foreign applicants must engage a BRH in Brazil to act as the point of contact with ANVISA. This local entity is responsible for managing the registration process and ensuring compliance with Brazilian regulations.

For detailed guidance, it is highly recommended to consult with an experienced regulatory expert in Brazil to navigate the process smoothly.