The processing time for Class C medical device registration with the Saudi Food and Drug Authority (SFDA) can vary based on several factors, including the complexity of the device, the completeness of the submitted documentation, and any additional reviews or testing required. However, a general timeline is as follows:

Processing Time for Class C Medical Device SFDA Registration

1. Pre-Submission Preparation

   • Preparation Time: Gathering and preparing the required documentation, including technical files, clinical data, and risk management, can take 1 to 3 months depending on the complexity of the device and the availability of data.

2. Submission and Review

   • Initial Review: Once submitted, the SFDA typically takes 6 to 12 months to review a Class C medical device application. This period includes evaluating the technical documentation, clinical evidence, and compliance with SFDA regulations.
   • Requests for Additional Information: If the SFDA requests additional information or clarification, this can extend the review period. Responding promptly can help mitigate delays.

3. Final Approval

   • Approval Time: After the review is complete, if the device is approved, the SFDA will issue a Medical Device Marketing Authorization (MDMA). The time from submission to final approval usually falls within the 6 to 12-month range.

4. Post-Submission Factors

   • Complexity of the Device: More complex devices or those requiring additional testing may take longer.
   • SFDA Workload: The SFDA’s workload and the number of applications being processed at the time can impact processing times.

Summary

• Total Processing Time: From preparation to receiving approval, the entire process for a Class C medical device registration generally takes 6 to 12 months.

For the most accurate and up-to-date information, you may want to consult with a regulatory affairs expert or directly contact the SFDA. If there are any changes or updates to the process, they will be able to provide the latest details.