The registration process for Class II medical devices with ANVISA (Agência Nacional de Vigilância Sanitária) in Brazil involves several key steps. Below is a detailed overview of the processes and steps required for registration:

1. Device Classification

• Determine Classification: Confirm that your device is classified as Class II according to the Brazilian classification system. Class II devices are typically associated with moderate risk and include surgical instruments, diagnostic devices, and other therapeutic tools.

2. Preparation of Documentation

Prepare the necessary documentation required for submission, which typically includes:

• Technical File: This includes:

  • Device Description: Details about the device, including specifications, materials, and intended use.
  • Manufacturing Information: Description of the manufacturing process, including facilities and equipment used.
  • Risk Analysis: A thorough analysis following ISO 14971 that identifies potential risks associated with the device and mitigation strategies.

• Safety and Efficacy Evidence: Provide clinical data, literature reviews, or other evidence demonstrating the device’s safety and effectiveness.

• Quality Management System (QMS): Documentation proving compliance with ISO 13485 or relevant quality management standards.

• Labeling: Draft labels and instructions for use in Portuguese, including warnings, contraindications, and usage guidelines.

• Declaration of Conformity: A document stating that the device meets all applicable regulatory requirements.

3. Legal Representation

• Appoint a Brazilian Legal Representative: If the applicant is not based in Brazil, they must appoint a local representative who will act as the liaison with ANVISA and handle all communications related to the registration process.

4. Application Submission

• Online Submission: Submit the application through ANVISA's electronic system, e-ANVISA. Create an account if you do not already have one.

• Complete the Application Form: Fill out the required forms in the system, ensuring all information is accurate and complete.

5. Payment of Fees

• Fee Payment: Pay the necessary registration fees. The fee amount will depend on the specific characteristics of the device and the registration process.

6. ANVISA Review Process

• Document Review: ANVISA will review the submitted application and documentation. This review may include:
  • Verification of compliance with technical and regulatory standards.
  • Assessment of the safety and effectiveness evidence.
• Additional Information Requests: ANVISA may request further information or clarifications during the review process. Respond promptly to any inquiries to avoid delays.

7. Approval and Registration

• Receive Registration Number: If your application is approved, ANVISA will issue a registration number, and your device will be listed in ANVISA's medical device registry.

• Certificate Issuance: You may receive a registration certificate, which serves as proof of compliance.

8. Post-Market Surveillance and Reporting

• Compliance with Post-Market Regulations: After registration, ensure compliance with ongoing regulatory requirements, including:
  • Reporting adverse events associated with the device.
  • Conducting regular safety updates and maintaining product quality.
  • Adhering to any conditions or requirements specified by ANVISA during the registration process.

Additional Considerations

• Regulatory Updates: Regularly check ANVISA’s official website for updates on regulations and guidance related to medical devices.
• Consult Regulatory Experts: If needed, consider engaging with regulatory consultants who specialize in ANVISA processes to facilitate a smooth registration process.

Useful Links

• ANVISA Official Website: ANVISA Website
• Guidance Documents: Review ANVISA’s published guidelines for specific medical devices to understand the requirements better.

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

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