The cycle for Class II medical device registration with ANVISA (Agência Nacional de Vigilância Sanitária) typically involves several phases, from preparation to approval. Here's a breakdown of the expected timeline:

1. Preparation Phase

• Duration: 1 to 3 months (or longer, depending on device complexity and documentation readiness).
• Activities: This phase includes gathering and preparing all necessary documentation, such as the technical file, clinical evaluation data, quality management system documents, risk management documentation, and labeling.

2. Application Submission

• Duration: Immediate upon completion of documentation.
• Activities: The application is submitted electronically through ANVISA’s online system (Sistema de Peticionamento Eletrônico - SPE), including payment of the registration fee.

3. ANVISA Review Process

• Total Review Duration: Up to 90 days, which may be broken down as follows:
  • Initial Review: 1 to 10 days. ANVISA conducts a preliminary check to ensure the application is complete.
  • Technical Evaluation: Up to 60 days. ANVISA's technical team reviews the documentation for safety, efficacy, and compliance with applicable standards.
  • Requests for Additional Information: If ANVISA requires further information, this can extend the timeline. The response time will depend on how quickly the manufacturer provides the requested details.
  • Final Decision: After the technical evaluation, ANVISA makes a decision, which may take an additional 20 days.

4. Approval and Post-Market Activities

• Duration: Immediate upon receiving the registration certificate.
• Activities: After approval, the manufacturer must implement post-market surveillance and ensure ongoing compliance with regulatory standards.

Summary of the Total Cycle Duration

• Overall Cycle: From preparation to approval, the entire process typically takes approximately 3 to 6 months. However, this timeline can vary based on factors such as the complexity of the device, completeness of the application, and responsiveness to any requests for additional information.

Key Considerations

• Preparedness: Proper preparation of documentation can significantly reduce delays during the application and review process.
• Responsiveness: Timely responses to ANVISA’s queries can help expedite the review.
• Monitoring Changes: Stay informed about any updates to ANVISA regulations or procedures that may affect processing times.

If you have any further questions or need specific details regarding any part of the registration cycle, feel free to ask!