To apply for Class III medical device registration with Brazil's ANVISA (Agência Nacional de Vigilância Sanitária), you must follow specific steps and submit your application through the ANVISA Solicita system. Here is a detailed guide on how to apply and where to process the registration:

Steps to Apply for Class III Medical Device Registration with Brazil’s ANVISA

1. Appoint a Brazilian Registration Holder (BRH)

• Foreign manufacturers must appoint a Brazilian Registration Holder (BRH). This is a local entity (e.g., a distributor or importer) that will act as the point of contact between ANVISA and the foreign manufacturer.
• Brazilian manufacturers can submit the application directly, without the need for a BRH.

Note: The BRH will be responsible for ensuring that the registration process is carried out in full compliance with ANVISA regulations.

2. Prepare the Required Documentation

Before you submit the application, you need to gather and prepare the following documents (as detailed in previous responses):

• Device Description: Detailed description of the device and its intended use.
• Clinical Data: Evidence demonstrating the safety and effectiveness of the device.
• Risk Management Report: Assessment of risks and risk control measures.
• Quality Management System (QMS) documentation (e.g., ISO 13485 certification).
• Labeling and Instructions for Use in Portuguese.
• GMP (Good Manufacturing Practices) certification.
• INMETRO certification (if applicable for electrical devices).

Ensure that all documents are translated into Portuguese and comply with ANVISA’s regulatory standards.

3. Create an Account on ANVISA’s Solicita System

The application for Class III medical device registration must be submitted through the Solicita system, which is ANVISA’s official electronic portal.

• Visit the ANVISA website and access the Solicita system: ANVISA Solicita Portal.
• Create an account or log in if you already have one. Foreign applicants (via their BRH) will need to log in with the credentials of the BRH.

4. Submit the Application via Solicita

After logging in to Solicita, the following steps are required:

• Fill in the application form: Provide detailed information about the device, including its intended use, manufacturing process, and technical specifications.
• Upload all required documentation: This includes the device description, clinical evidence, risk management documentation, labeling, and proof of GMP certification.
• Payment of Registration Fees: The registration fee must be paid through the Solicita system. The fee varies depending on the type of device and the registration process.
• Submit the application: Once the documentation is complete and payment is confirmed, submit the application.

5. Review Process by ANVISA

• ANVISA will review the application and the submitted documents. This review typically takes between 12 to 18 months for Class III devices, as they are high-risk products.
• During the review process, ANVISA may request additional information or clarification on specific aspects of the device.

6. Respond to ANVISA’s Requests

• If ANVISA asks for additional information, respond promptly and provide the required documentation. Delays in responding can extend the overall registration timeline.

7. Approval and Registration

• If the application meets ANVISA’s requirements, they will approve the registration and issue a registration certificate for the Class III medical device.
• Once approved, the device can be legally marketed in Brazil.

8. Post-Registration Obligations

• After registration, manufacturers and BRHs must comply with post-market surveillance requirements, such as reporting adverse events and product recalls if necessary.
• The device registration is typically valid for five years, after which it needs to be renewed.

Where to Process the Registration

The registration is processed entirely through the ANVISA Solicita system. The process is online, and all submissions (application forms, payment, and documents) must be made through the platform.

• Access the Solicita system on the official ANVISA website:
  ANVISA Solicita Portal
• The Brazilian Registration Holder (BRH), if applicable, will manage the submission on behalf of the manufacturer.

Important Notes

• Brazilian Representation: A foreign manufacturer must engage a Brazilian Registration Holder to act as the local representative for regulatory and communication purposes with ANVISA.
• Portuguese Translation: All documents must be submitted in Portuguese, including the device description, clinical data, risk management reports, and labeling.
• Clinical Data: Class III devices require extensive clinical evidence to prove safety and effectiveness. ANVISA will scrutinize this data thoroughly.
• Compliance with Local Standards: Ensure that the device complies with INMETRO and GMP requirements, as these certifications are often mandatory for Class III devices.

By following these steps and submitting the required documentation through the Solicita system, you can initiate the registration process for a Class III medical device with Brazil’s ANVISA.

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