The registration processing time for D-class medical devices with the Saudi Food and Drug Authority (SFDA) can vary based on several factors, including the completeness of your submission, the device’s compliance with SFDA requirements, and the workload of the SFDA at the time of application. However, on average, the registration process for D-class medical devices generally follows this timeline:

Typical Registration Processing Time for D-Class Medical Devices:

• Processing Time: The typical registration time for D-class devices is approximately 1 to 3 months from the date of submission to the SFDA, assuming the submission is complete and meets all requirements.

Key Factors That Influence Processing Time:

1. Completeness and Accuracy of the Application:

   • If your application is complete and contains all the necessary documentation (such as ISO 13485, CFS, risk assessment, etc.), the SFDA is more likely to process the application faster. Missing or incomplete documents may cause delays.

2. Device Type and Complexity:

   • While D-class devices are low-risk and generally simpler, more complex or novel devices—even within the D-class category—may take longer for review due to additional scrutiny or requests for more information.

3. SFDA’s Workload:

   • SFDA’s processing time can fluctuate depending on the volume of applications they are handling at any given time. During peak periods, such as after new regulatory updates, the process might take longer.

4. Follow-Up Requests:

   • If the SFDA requires additional information, clarification, or modification of submitted documents, this could extend the timeline. Therefore, it is important to provide clear, complete, and accurate documentation during the initial submission.

5. Payment Confirmation:

   • Ensure that you have completed the payment of the required registration fee, as delays in payment can affect the processing timeline.

6. Local Authorized Representative (LAR) Role:

   • The LAR (Local Authorized Representative) will be responsible for submitting and managing the registration process. If the LAR is unfamiliar with the process or submits incomplete documents, this could result in delays.

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