The processing time for Class C 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 type of device, and whether additional information or inspections are required. However, on average, the process typically takes 3 to 6 months from the submission of your application to the final approval.

Breakdown of the Processing Time:

1. Initial Submission and Application Review (1-2 months)

   • Once the Class C medical device application is submitted through the SFDA Medical Device Registration Portal, the SFDA will review the application, the submitted documentation (including clinical data, risk management files, and ISO certificates), and ensure that all the requirements are met.
   • If the application is complete and no further clarifications are needed, this review period can take approximately 1 to 2 months.

2. Additional Information or Clarifications (1-2 months)

   • If the SFDA requires additional documentation, clarification, or specific details (e.g., clinical trial data, performance testing results), it may take additional time to provide the necessary information.
   • Back-and-forth communication with the SFDA to resolve any issues can extend the processing time by 1 to 2 months.

3. Inspection of Manufacturing Site (If Applicable) (1 month or more)

   • If the device is manufactured outside Saudi Arabia, the SFDA may require an inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP).
   • The timing for this inspection will depend on the location of the manufacturing site, the availability of inspection resources, and the timing of the inspection request. This can add an additional 1 month or more to the overall processing time.

4. Final Review and Approval (1-2 months)

   • After receiving all necessary documents and clarifications, the SFDA will complete the final review of the application.
   • If the application is successful, the Certificate of Registration for the Class C medical device will be issued, typically within 1 to 2 months after all requirements are met.

Factors that Can Impact the Processing Time:

• Completeness of Application: Submitting a complete and accurate application with all required documents can speed up the process. Missing or incomplete information can cause delays.
• Device Complexity: More complex devices, especially those requiring clinical data or special testing, may take longer to review.
• Need for Inspections: If the device is manufactured outside Saudi Arabia, an inspection of the manufacturing site might be required, which can add additional time.
• SFDA Backlog: The processing time may vary depending on the volume of applications being processed at any given time. During peak periods or if there is a backlog of applications, it may take longer.

Summary of Estimated Processing Time for Class C Registration:

• Normal processing time: 3 to 6 months.
• Factors that can delay the process: Incomplete applications, requests for additional information, manufacturing site inspections, and SFDA workload.

It's always a good idea to keep track of your application status through the SFDA Medical Device Registration Portal and be ready to provide any additional information if requested.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn