The time it takes to obtain B-class medical device registration with the Saudi Food and Drug Authority (SFDA) can vary depending on several factors such as the completeness of your application, the complexity of the device, and SFDA's current workload. However, the typical time cycle for B-class device registration is as follows:

Typical Timeline for B-Class Medical Device Registration:

1. Preparation Phase: 2-4 weeks

   • Gathering Documentation: Before submitting your application, you need to collect all the required documents, including clinical data, risk management documents, device labeling, and quality management certifications (e.g., ISO 13485).
   • If you're a foreign manufacturer, you also need to appoint a Local Authorized Representative (LAR) in Saudi Arabia.

2. Submission of Application: 1-2 weeks

   • Once all the documents are ready, the application is submitted through the SFDA MDA Portal.
   • During this period, you will enter information about the device, its intended use, and all supporting documents.

3. SFDA Review Process: 4-8 weeks

   • After submission, SFDA will review the application and all accompanying documentation.
   • The review process includes checking the device classification, assessing clinical data, confirming quality management compliance (ISO 13485), and verifying the safety and performance of the device.
   • If SFDA finds any issues or requires additional information, they may request clarification or supplementary documents, which can extend the timeline.

4. Additional Testing or Inspection (if applicable): Varies (1-4 weeks or longer)

   • If additional testing (e.g., biocompatibility, electrical safety) is required, or if an inspection of the manufacturing facility is needed, this could add time to the overall process.
   • If you're a foreign manufacturer, an inspection of the manufacturing facility may take more time depending on the location.

5. Decision and Issuance of Registration: 1-2 weeks

   • Once the SFDA has reviewed all materials and is satisfied with the submission, they will issue the Certificate of Registration.
   • The total processing time from submission to final approval can range from 3 to 6 months.

Factors That May Affect the Timeline:

1. Completeness of Application: If the application is incomplete or lacks essential documents, SFDA may request additional information, which will delay the process.
2. Device Complexity: More complex devices, especially those that may require additional clinical data or testing, may take longer to review.
3. Inspection Requirements: If an inspection of the manufacturing facility or additional laboratory testing is required, it will add time to the process.
4. SFDA Workload: SFDA’s workload can impact the processing time. During busy periods, such as when there is a surge in applications, the review process may take longer.

Estimated Total Time: 3-6 months

• Typically, it takes around 3 to 6 months from the submission of the application to the issuance of the Certificate of Registration for B-class medical devices. However, this timeline may vary depending on the factors listed above.

Steps in the Review Process:

1. Document Verification: SFDA verifies that the submitted documents are complete and comply with local regulations.
2. Technical Review: SFDA reviews the technical and clinical data to ensure the device’s safety and performance.
3. Quality Compliance Check: SFDA checks whether the manufacturer follows ISO 13485 or other relevant quality management systems.
4. Issuance of Registration: If everything is in order, the SFDA issues the Certificate of Registration, allowing the device to be sold in Saudi Arabia.

Conclusion

To summarize, obtaining B-class medical device registration with the Saudi SFDA typically takes 3 to 6 months, but this can vary depending on the completeness of the application, the complexity of the device, and any additional requirements (e.g., inspections or additional testing).