The processing time for Class III medical device registration with Brazil's ANVISA typically ranges from 12 to 18 months. This timeframe can vary based on several factors, including the complexity of the device, the completeness of the submission, and whether additional information or clarifications are requested during the review process. Here's a breakdown of the factors that can influence the processing time:

Factors Affecting Processing Time

1. Completeness of Documentation:

   • If the submitted application and technical documents are complete and meet ANVISA's requirements, the review process will likely proceed more smoothly and efficiently. Missing or incomplete documents can cause delays.

2. Clinical Data Review:

   • For Class III devices, which are considered high-risk, ANVISA will closely scrutinize the clinical evidence (including clinical trials, data on safety, efficacy, and risk management). If additional data or studies are required, this can extend the review time.

3. Requests for Additional Information:

   • ANVISA may request clarification or additional documentation, which will extend the processing time. Timely and complete responses to ANVISA's queries can help minimize delays.

4. Manufacturing Site Inspection:

   • If the device is manufactured outside of Brazil, ANVISA may require an inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP). Scheduling and completing this inspection can take additional time.
   • INMETRO Certification: If the device involves electrical or electromagnetic components, obtaining INMETRO certification for the device’s safety can also add time.

5. Workload at ANVISA:

   • The number of applications being processed at ANVISA and any changes in regulatory procedures can impact the review time. In times of increased submissions or staffing changes, delays may occur.

Typical Timeline Breakdown

• Initial Application Review: 3 to 6 months, depending on the completeness of the submission and ANVISA's initial assessment.
• Request for Additional Information: If any documents or data are missing or need clarification, this can extend the process by several months.
• Inspection and Certification (if applicable): If the device requires a GMP inspection or INMETRO certification, this step can take an additional 2-4 months, depending on the location of the manufacturing site and the availability of inspection resources.
• Final Approval: After ANVISA reviews the application and any additional information, approval can take another 3 to 6 months.

Summary Timeline

• Average Processing Time: 12 to 18 months from submission to final approval.
• Potential for Delays: Missing information, additional data requests, or inspection requirements could add several months to the timeline.

To minimize delays, it is important to ensure that the application is complete, all required documentation is submitted in Portuguese, and the device complies with ANVISA’s regulations from the outset. Regular communication with your Brazilian Registration Holder (BRH) and monitoring the Solicita system can help you track the progress of your application.

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