The time frame for Class C medical device SFDA registration in Saudi Arabia can vary based on several factors, including the complexity of the device, the completeness of the application, and the responsiveness to any additional information requests from the SFDA. Here is a general outline of the time frame and key stages involved in the process:

Time Frame for Class C Medical Device SFDA Registration

1. Preparation Phase:

   • Documentation and Preparation: This phase involves gathering and preparing all necessary documentation, including the technical file, clinical data, and Quality Management System (QMS) information. This can take several weeks to months, depending on the complexity of the device and the availability of the required information.

2. Application Submission:

   • Portal Submission: Once all documentation is prepared, the application is submitted via the SFDA's GHAD (Generic Health and Drug) portal. This step is relatively quick but depends on the efficiency of the submission process.

3. Review Phase:

   • Initial Screening: SFDA conducts an initial screening to ensure that the application is complete. This usually takes a few weeks.
   • Technical Review: The technical review involves a detailed evaluation of the device's documentation and compliance with regulatory standards. For Class C devices, this review can be more extensive and may take approximately 3 to 6 months. Complex devices or incomplete submissions may extend this period.

4. Additional Information Requests:

   • Response Time: If SFDA requests additional information or clarifications, the time to respond can affect the overall processing time. The time frame for this depends on how quickly and comprehensively the additional information is provided.

5. Approval and Issuance:

   • Final Decision: After completing the review, SFDA will issue a decision. If approved, a registration certificate is issued. The approval process can take an additional few weeks after the final review.

Summary of Time Frames

• Preparation Phase: Several weeks to months.
• Initial Screening: A few weeks.
• Technical Review: Approximately 3 to 6 months.
• Additional Information Requests: Variable, depending on response time.
• Approval and Issuance: A few weeks after the final review.

Total Estimated Time

• Overall Time Frame: Generally, the entire process from submission to approval can take around 6 to 12 months. This estimate can vary based on the specific circumstances of the device and the efficiency of the submission and review process.