The time frame for obtaining Class C medical device SFDA registration in Saudi Arabia typically ranges from 6 to 12 months. This duration can vary depending on several factors, including:

Factors Influencing the Time Frame

1. Completeness of Submission:

   • Complete Documentation: The process is faster if the initial application is complete and includes all required documentation. Incomplete or incorrect submissions can lead to delays.

2. Complexity of the Device:

   • Technical Complexity: Devices with higher complexity or innovative technologies may require a more detailed review, potentially extending the processing time.

3. SFDA Review Process:

   • Initial Screening: SFDA’s preliminary review to check if all necessary information is provided usually takes a few weeks.
   • Technical Review: The detailed evaluation of the device’s technical file, clinical data, and compliance with standards can take approximately 3 to 6 months. For complex devices, this may be extended.

4. Additional Information Requests:

   • Supplementary Information: If SFDA requests additional information or clarifications, the time required to respond can affect the overall processing time.

5. Applicant Response Time:

   • Timeliness: How quickly and thoroughly the applicant responds to any queries or requests for additional information will impact the total duration.

6. Regulatory Workload:

   • SFDA Workload: The SFDA’s workload and the number of applications being processed at the time can also influence the time frame.

General Process Stages

1. Preparation Phase:

   • Documentation Preparation: Several weeks to months, depending on the complexity of the device and the readiness of the documentation.

2. Application Submission:

   • Submission: Once submitted, it is usually processed relatively quickly, though this depends on the completeness of the application.

3. Review Phase:

   • Initial Screening: A few weeks.
   • Technical Review: Approximately 3 to 6 months.

4. Additional Information Requests:

   • Response Time: Variable, depending on how quickly and thoroughly the additional information is provided.

5. Approval and Issuance:

   • Final Decision: A few weeks after the final review.