The processing time for Class I medical device registration with Brazil's ANVISA generally ranges from 30 to 60 days, depending on several factors such as the completeness of the application and whether additional information or clarification is needed.

Key Points About the Processing Time:

1. Initial Submission: After the submission of the required documents via ANVISA’s e-Submission platform (SNGPC), ANVISA will begin reviewing the application.
2. Completeness of Documentation: If the application is complete and complies with all regulatory requirements, the review process is typically quicker.
3. Additional Requests: If ANVISA requires more information or clarification, the process may take longer. The Brazilian Registration Holder (BRH), who is submitting the application on behalf of the manufacturer, will be contacted by ANVISA.
4. Type of Device: While Class I devices are considered low-risk and usually have a faster processing time, the complexity of the device or any special regulatory requirements can still impact the review timeline.

General Steps Involved in the Processing:

1. Application Submission: The BRH submits the complete application through SNGPC.
2. Initial Review: ANVISA checks the application for completeness and compliance with regulatory standards.
3. Communication with BRH: If needed, ANVISA will request additional documents or clarifications.
4. Final Approval: Once ANVISA is satisfied with the application, the device is officially registered.

Typical Timeline:

• 30 to 60 days is the general timeframe from the moment the application is submitted until the registration is granted.
• However, delays can occur if there are issues with the documentation or if further testing or evidence is required for product safety or quality.

It is important to ensure that all required documents are complete and accurate when submitting the application to avoid delays.

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