The time cycle for B-class medical device registration with the Saudi Food and Drug Authority (SFDA) generally involves several stages, and the total time for completion can vary depending on factors such as the completeness of the application, the complexity of the device, and SFDA’s workload at the time. However, the typical time cycle for this process is as follows:

1. Preparation Phase

• Time: 2–4 weeks
• Before submitting the application, you will need time to gather the required documents, including:
  • Device classification information.
  • Quality management system certifications (e.g., ISO 13485).
  • Clinical data, risk management documentation, labeling, and other necessary materials.
  • If you are a foreign manufacturer, appointing a Local Authorized Representative (LAR) in Saudi Arabia is also required.

2. Submission of Application

• Time: 1–2 weeks
• Once all necessary documentation is prepared, you can submit your application via the SFDA MDA Portal.
• After submission, the SFDA will initiate the review process, which may take several weeks depending on their review workload.

3. SFDA Review Process

• Time: 4–8 weeks (approx.)
• SFDA will review the submitted documents to ensure they comply with all regulatory requirements.
  • The review process typically involves checking the device's classification, examining clinical data and performance, verifying compliance with ISO 13485 for quality management, and ensuring proper labeling and risk management.
• If SFDA finds any issues or missing information, they may request additional documentation or clarification. This will extend the overall processing time.

4. Additional Requests or Testing (if applicable)

• Time: Varies (1–4 weeks or longer)
• If SFDA requires further testing (e.g., biocompatibility tests or electrical safety) or an inspection of the manufacturing facility (especially for foreign manufacturers), this will add time to the process. The time required depends on the complexity of the device and testing requirements.

5. Decision and Registration

• Time: 1–2 weeks after review completion
• Once the SFDA is satisfied with the documentation and testing results, they will issue the Certificate of Registration.
• The registration process can be completed within 3–6 months from the submission date, assuming the application is complete and no significant issues arise during the review process.

6. Post-Approval and Annual Renewal

• Time: Ongoing
• Once the device is registered, the approval is valid for one year. You will need to submit an annual renewal application, which involves updating the registration information and paying renewal fees. The renewal process usually takes 2–4 weeks.

Estimated Total Time Cycle

• Overall time cycle for registration: Typically 3–6 months, depending on the complexity of the device and the completeness of the application.

Factors that May Affect the Timeline:

1. Application Completeness: If any documents are missing or unclear, SFDA may request additional information, which can delay the process.
2. Device Complexity: Devices that require additional testing, inspections, or clinical data may take longer to process.
3. SFDA Workload: During peak periods, SFDA's review process may take longer due to a higher number of submissions.
4. Foreign Manufacturer: If the manufacturer is located outside Saudi Arabia, the registration process may take slightly longer due to the need for additional verification or inspections.

By preparing all necessary documentation in advance and ensuring that the application is complete and accurate, you can help streamline the process and reduce potential delays.

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