The D-class medical device registration process with the Saudi Food and Drug Authority (SFDA) typically takes approximately 3 to 4 weeks to complete, assuming that the application is complete, all required documents are in order, and there are no additional requests for clarification or additional information.

Key Steps and Estimated Timeframes:

1. Submission of Application:

   • Once you submit your application through the Saudi Drug Registration System (SDRS), the SFDA will acknowledge receipt and begin the initial review of your documents.
   • Estimated time: 2 to 5 business days for initial submission acknowledgment.

2. Document Review:

   • The SFDA will assess your device's technical documentation, including its description, risk management reports, quality management system certifications (such as ISO 13485), and labeling (in both Arabic and English).
   • This is the most time-consuming part of the process, as the SFDA needs to ensure that the device complies with all safety, quality, and performance requirements.
   • Estimated time: 2 to 3 weeks, depending on the complexity of the device and the completeness of the documentation submitted.

3. Approval or Request for Additional Information:

   • If the documentation meets all regulatory requirements, the SFDA will approve the registration and issue the registration certificate.
   • If the SFDA needs more information, they will request it, which can extend the review period.
   • Estimated time: Up to 1 week after document review, if no additional information is requested.

4. Issuance of Registration Certificate:

   • Once approved, the SFDA will issue the registration certificate, which authorizes the manufacturer to market the device in Saudi Arabia.
   • Estimated time: A few days to issue the certificate after final approval.

Total Estimated Time:

• Under normal circumstances, 3 to 4 weeks from the submission of the application to the receipt of the registration certificate.
• Delays can occur if the SFDA requests additional documents or clarifications, in which case the timeline could extend beyond 4 weeks.

Factors Influencing the Timeframe:

• Completeness of Documentation: If the application is incomplete or if there are issues with the submitted documents, the review time could be extended.
• Device Complexity: While D-class devices are low-risk, more complex devices may take slightly longer to review.
• SFDA Workload: Processing times can vary depending on the SFDA's workload and how many applications they are handling at a given time.

Conclusion:

In general, 3 to 4 weeks is the typical timeframe to obtain D-class medical device registration with the Saudi SFDA, provided that the application is complete and the device meets all regulatory requirements. Any delays or requests for additional information could extend the process.