The application process for Class II medical device registration with ANVISA (Agência Nacional de Vigilância Sanitária) involves several stages and a typical timeline for completion. Here's an overview of the expected duration for each stage of the process and the overall review timeline.

Overall Timeline for Application

1. Preparation Phase:

   • Duration: 1 to 3 months (or longer, depending on the complexity of the device and readiness of documentation).
   • Activities: During this phase, you gather and prepare all necessary documentation, including technical files, quality management system documents, clinical evaluations, labeling, and any other required materials.

2. Submission Phase:

   • Duration: Immediate upon completion of documentation.
   • Activities: Submit the application electronically via ANVISA’s online system (Sistema de Peticionamento Eletrônico - SPE). Pay the registration fee as required.

3. ANVISA Review Process:

   • Duration: Up to 90 days, depending on the completeness of the application and the complexity of the device.
   • Stages of Review:
     • Initial Review (1-10 days): ANVISA conducts an initial review to verify that the application is complete and meets all submission requirements.
     • Technical Evaluation (up to 60 days): The technical team at ANVISA assesses the technical documentation, including safety, effectiveness, and compliance with relevant standards.
     • Possible Additional Requests (varies): If ANVISA requires further information or clarification, they will send a request to the applicant. The timeline for this stage can extend if responses are needed.
     • Final Decision (up to 20 days): Once the technical evaluation is completed, ANVISA will make a final decision. If approved, a registration certificate will be issued.

4. Post-Approval Phase:

   • Duration: Immediate upon receipt of the registration certificate.
   • Activities: Implement post-market surveillance and ensure compliance with quality management standards ongoingly.

Summary of Timeline

• Total Duration: From preparation to approval, the entire process may take approximately 3 to 6 months, but this can vary based on factors such as the complexity of the device, completeness of the application, and responsiveness to any requests for additional information from ANVISA.

Key Considerations

• Preparedness: Ensure that all documentation is thoroughly prepared and complies with ANVISA's requirements before submission to avoid delays during the review process.
• Response Time: Be prompt in responding to any queries or requests from ANVISA, as delays in communication can extend the overall timeline.
• Regulatory Changes: Stay updated on any changes to ANVISA regulations that may affect processing times or requirements.

Conclusion

In summary, while the application for Class II medical device registration with ANVISA can take several months, careful preparation and adherence to submission requirements can facilitate a smoother review process. Being proactive in addressing ANVISA’s inquiries and ensuring compliance will contribute to timely registration. If you have any further questions or need assistance with specific aspects of the registration process, feel free to ask!