The D-class medical device registration process with the Saudi Food and Drug Authority (SFDA) typically takes approximately 3 to 4 weeks to complete, depending on several factors, including the completeness of the application and the complexity of the device.

Key Phases of the Registration Process:

1. Initial Submission:

   • Once the application is submitted via the Saudi Drug Registration System (SDRS), the SFDA will acknowledge receipt and start reviewing the provided documentation. This can take a few days.
   • Estimated time: 2-5 business days for initial submission acknowledgment.

2. Documentation Review:

   • The SFDA will assess the device description, quality management system (ISO 13485), risk management reports (ISO 14971), and labeling (in both Arabic and English).
   • If the submitted documents are complete and compliant, the SFDA will proceed with a detailed review.
   • Estimated time: This part of the process can take 2 to 3 weeks on average, depending on the device's complexity and whether the SFDA requires additional clarifications or documents.

3. Approval or Request for Additional Information:

   • If there are no issues or requests for additional information, the SFDA will approve the registration and issue a registration certificate.
   • Estimated time: If no additional information is required, the approval process can take a few days to a week after the review.
   • If additional information is needed, the SFDA will request it, and this can delay the process depending on how quickly you respond.

4. Issuance of Registration Certificate:

   • Once approved, the SFDA will issue the registration certificate, which typically takes a few days to be issued after the final approval.

Total Estimated Time:

• Standard Timeframe: The total time for the D-class medical device registration process with the SFDA is generally 3 to 4 weeks if the application is complete and all documents are in order.

• Possible Delays: Any missing documentation, non-compliance with SFDA guidelines, or requests for additional clarifications could extend the process. If there are issues, the process could take up to 6 weeks or longer.

Factors Influencing the Duration:

1. Completeness of Application: If the application is complete and all required documents are submitted, the review will be faster.
2. Complexity of the Device: If the device is simple and well-documented, it will typically be processed faster. More complex devices may require additional review time.
3. Response Time: Delays may occur if the SFDA requests additional information and the applicant takes time to provide it.

In summary, the registration process for D-class medical devices with the Saudi SFDA typically takes 3 to 4 weeks under normal circumstances, but it could be shorter or longer depending on the application’s completeness and the SFDA’s review process.