To apply for Class II medical device registration with ANVISA (Agência Nacional de Vigilância Sanitária) in Brazil, you will need to follow a series of steps outlined below:

Step-by-Step Process

1. Determine the Classification:

   • Confirm that your device is classified as Class II according to ANVISA regulations. Class II devices typically have moderate risk and require a registration process.

2. Compile Documentation:

   • Prepare the necessary documentation, which usually includes:
     • Technical File: This should contain detailed information about the device, including design, manufacturing process, intended use, labeling, and risk analysis.
     • Clinical Evaluation: Provide evidence of the device’s safety and effectiveness. This may include clinical studies or literature reviews.
     • Quality Management System (QMS): Evidence of compliance with ISO 13485 or other relevant standards.
     • Declaration of Conformity: Document stating that the device meets applicable regulatory requirements.
     • Labeling and Instructions for Use: Include translations into Portuguese as required.

3. Establish a Brazilian Legal Representative:

   • If you are not based in Brazil, you must appoint a local representative (representante legal) who will act on your behalf in all communications with ANVISA.

4. Submit the Application:

   • Applications must be submitted through ANVISA's electronic system (SISCOMEX or e-ANVISA). Ensure that all documents are correctly formatted and complete.

5. Pay the Fees:

   • Pay the required registration fees. The amount can vary depending on the device and the specifics of the application.

6. ANVISA Review:

   • Once submitted, ANVISA will review your application. They may request additional information or clarifications during the review process.

7. Approval:

   • If your application is approved, you will receive a registration number, and your device will be listed in ANVISA's database.

8. Post-Market Surveillance:

   • After registration, comply with post-market surveillance requirements, including reporting adverse events and conducting periodic safety updates.

Additional Considerations

• Consult ANVISA Guidelines: Familiarize yourself with ANVISA's specific guidelines for medical device registration. This includes any updates or changes to the regulatory framework.
• Engage a Regulatory Consultant: Consider hiring a regulatory affairs consultant with expertise in ANVISA processes to assist with the application.

Useful Resources

• ANVISA’s official website provides comprehensive guidance and documentation for medical device registration: ANVISA Website.

Following these steps will help you navigate the registration process for Class II medical devices in Brazil. If you have any specific questions or need further assistance, feel free to ask!

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