The time required to obtain D-class 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 SFDA's current workload. However, in general, the entire process from application submission to approval typically takes between 6 to 12 months.

Estimated Timeline for D-Class Medical Device SFDA Registration:

1. Preliminary Preparation and Document Compilation

   • Time: 1 to 2 months
     This involves gathering all necessary documentation, such as:
     • Clinical evaluation and trial data
     • Risk management documentation (ISO 14971)
     • Manufacturing certifications (e.g., GMP)
     • Labeling and Instructions for Use (IFU) in Arabic and English
     • Evidence of compliance with international standards (e.g., ISO 13485, IEC 60601)

2. Account Registration and Initial Submission

   • Time: 1 to 2 weeks
     • Create an account on SFDA’s Unified Electronic System (SUES).
     • Register as a manufacturer or authorized representative, if not already done.
     • Submit the initial application along with required documentation for the device.

3. SFDA Administrative Review

   • Time: 1 to 2 weeks
     • SFDA checks the submitted documentation for completeness and accuracy. If there are any issues, they will request clarifications or missing documents.

4. SFDA Technical Review and Evaluation

   • Time: 3 to 6 months
     • This is the most time-consuming step. SFDA evaluates the technical documentation, including clinical trial results, safety data, and risk management procedures.
     • They may request additional information or clarifications, which can add time to the process.
     • SFDA may also request an inspection of the manufacturing facility (if applicable) to ensure compliance with Good Manufacturing Practices (GMP).

5. Issuance of Approval and Registration Certificate

   • Time: 1 to 2 weeks
     • If everything is in order and the device passes the review process, SFDA will approve the registration and issue the official registration certificate.
     • After receiving approval, your device can be legally marketed in Saudi Arabia.

Total Estimated Timeline: 6 to 12 months

• 6 months: If the documentation is complete and the device passes technical evaluation without any issues or additional requests.
• 12 months: If there are complications or requests for additional information, or if the SFDA needs to conduct a site inspection.

Factors That May Influence the Timeline:

• Completeness of the Application: Submitting complete, accurate, and well-prepared documentation can speed up the process. Missing documents or errors can delay the review.
• SFDA’s Workload: If SFDA is processing a high number of applications, it might take longer.
• Inspection Requirements: If your device is manufactured outside of Saudi Arabia, SFDA may require an inspection of the manufacturing site, which adds time.
• Device Complexity: High-risk D-class devices often require more comprehensive documentation and evaluation, which can take more time for SFDA to review.
• Additional Requests for Information: SFDA may ask for further clarifications, especially for high-risk devices. The speed at which you can respond to these requests will impact the overall timeline.

Conclusion

While the typical timeline for D-class medical device SFDA registration is around 6 to 12 months, it’s important to prepare thoroughly and be responsive to any requests from SFDA to avoid unnecessary delays. Planning ahead and starting the process early can help ensure that your device enters the Saudi market on time.

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