The processing time for Class D medical device registration with the Saudi Food and Drug Authority (SFDA) can vary based on several factors, including the complexity of the device, the completeness of the submitted documentation, and the workload of the SFDA. However, here is a general overview of the typical timeline:

Typical Processing Time

1. Preparation Phase

   • Documentation Preparation: Before submission, preparing and organizing the required documentation can take several weeks to months, depending on the complexity of the device and the availability of data.

2. Submission and Initial Review

   • Application Submission: Once the application is submitted through the SFDA’s electronic system (SFDAsystem), the initial review typically takes 2 to 4 weeks.
   • Initial Review: The SFDA will perform an initial review to ensure that all required documents are included and that the application is complete.

3. Detailed Review and Evaluation

   • In-Depth Review: For Class D devices, which are high-risk, the SFDA will conduct a thorough review of the technical documentation, clinical data, and risk management reports. This detailed review can take 3 to 6 months or longer.
   • Additional Information: The SFDA may request additional information or clarification during this phase, which can extend the review period.

4. Inspection and Evaluation

   • Site Inspection: If an inspection of the manufacturing site is required, it will be scheduled and conducted. This can add additional time, depending on availability and scheduling.
   • Evaluation: Comprehensive evaluation, including any necessary consultations or assessments, can contribute to the overall processing time.

5. Approval and Certification

   • Decision and Issuance: After completing the review and evaluation, the SFDA will make a decision. If the application is approved, a registration certificate will be issued. This step typically takes 2 to 4 weeks after the review is complete.

Overall Timeframe

• Total Processing Time: From submission to receipt of the registration certificate, the entire process for Class D medical devices can take 6 to 12 months or more. This timeline can vary based on the specifics of each application and any additional requests for information or clarifications from the SFDA.

Recommendations

• Prepare Thoroughly: Ensure that all documentation is complete and accurate to avoid delays during the review process.
• Monitor Progress: Use the SFDA’s electronic system to track the status of your application and respond promptly to any requests for additional information.
• Consult Experts: Consider working with regulatory affairs professionals who are experienced in the Saudi market to help streamline the process and manage expectations.