Obtaining Class III medical device registration with Brazil's ANVISA typically takes 12 to 18 months, although the timeline can vary depending on several factors such as the complexity of the device, completeness of the application, and any additional requirements like inspections.

Timeline Breakdown:

1. Application Submission: Once the application is submitted, ANVISA conducts a preliminary evaluation of the documentation. This can take 1 to 2 months.
2. Technical Review: ANVISA’s technical team will conduct a detailed evaluation of the device’s safety, clinical data, risk management, and manufacturing processes. This process generally takes 4 to 8 months, depending on the complexity and completeness of the submission.
3. Facility Inspection (if required): If ANVISA requires an inspection of the manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP), this can add several months to the timeline, depending on the scheduling and readiness of the facility.
4. Final Decision: After completing the technical review and any necessary inspections, ANVISA will issue a final decision. This can take 2 to 3 months.

Factors Affecting the Timeline:

• Completeness of the Application: Submitting all required documents on time and without errors can speed up the process.
• Complexity of the Device: Devices requiring extensive clinical data, additional studies, or more detailed risk analysis may take longer to review.
• Inspection Requirement: If an on-site inspection is necessary, this will extend the timeline due to scheduling, travel, and preparation time.

In Summary:

On average, obtaining Class III medical device registration with ANVISA takes about 12 to 18 months, but it could take longer if additional requirements are necessary, such as facility inspections or if there are delays in submitting required information. Manufacturers should plan for this extended timeline when entering the Brazilian market.

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