The processing time for B-class medical device registration with the Saudi Food and Drug Authority (SFDA) can vary depending on several factors, including the complexity of the device, the completeness of the application, and the volume of applications being processed at the time. However, here are some general guidelines:

Estimated Processing Time for B-Class Medical Device Registration

1. Initial Review and Submission

   • Once your application is submitted via the Medical Device Electronic System (MDES), SFDA typically conducts an initial review to check the completeness of the application and documents. This step usually takes 1 to 2 weeks.

2. SFDA Review and Evaluation

   • The SFDA then performs a detailed technical evaluation of the submitted documents, including:
     • Review of the device classification.
     • Evaluation of the risk management documentation.
     • Checking for compliance with international standards (e.g., ISO 13485, ISO 14971).
     • Review of clinical data and testing (if applicable).
     • Evaluation of labeling and instructions for use (IFU).
   • The review period typically takes between 4 to 6 weeks, but it could take longer depending on the complexity of the device and the documentation provided.

3. Request for Additional Information

   • During the review process, SFDA may request additional information or clarification regarding the application.
   • If any additional documentation or responses are required, this can delay the process by 1 to 3 weeks or more, depending on how quickly the applicant responds.

4. Final Decision and Issuance of Registration

   • After reviewing all documentation and any additional information provided, SFDA will issue the final registration approval (or rejection) for the B-class device.
   • The final approval process usually takes an additional 1 to 2 weeks.

Total Estimated Time

• On average, the total processing time for B-class medical device registration with SFDA is around 8 to 12 weeks (2 to 3 months) from the submission of the application to the issuance of the registration certificate.

However, if there are issues with the documentation or if additional clarifications are needed, the timeline can extend to 3 to 4 months or longer.

Factors That Can Impact Processing Time

• Completeness of Documentation: Submitting a complete and well-organized application with all required documents can speed up the review process.
• Complexity of the Device: More complex devices (even within B-class) may require a more detailed review, which can extend the processing time.
• SFDA Workload: SFDA may experience periods of higher demand, such as during the release of new regulatory updates or during peak periods, which can increase the time for processing applications.
• Additional Requests: If SFDA requests further information or clarification, this can add time to the process.

Tips to Avoid Delays

• Ensure Complete Documentation: Double-check that all required documents are included, in the correct format, and in both Arabic and English where required.
• Respond Promptly to Requests: If SFDA asks for additional information or clarifications, provide them as quickly and thoroughly as possible to avoid delays.
• Use a Local Authorized Representative: If you're an international manufacturer, ensure your local authorized representative (LAR) is registered with SFDA and well-versed in the submission process.

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