The processing time for registering an A-class medical device with the Saudi Food and Drug Authority (SFDA) typically ranges between 4 to 12 weeks. This timeframe can vary depending on several factors, including the completeness of your application, the complexity of the device, and the SFDA’s workload.

Factors Affecting Processing Time:

1. Completeness of the Application:

   • If all required documents are provided and meet the SFDA's standards, the review process can be faster. Incomplete or incorrect documentation may lead to delays as the SFDA may request additional information.

2. Device Classification and Risk Assessment:

   • A-class devices are generally low-risk, which typically results in a faster review process compared to higher-risk (Class B, C, D) devices. However, if additional documentation or testing is required, it could extend the processing time.

3. SFDA’s Review Queue:

   • Processing time can also be influenced by the SFDA’s workload and the volume of applications being processed at the time. If there is a backlog, the review process may take longer.

4. Requests for Additional Information:

   • The SFDA may request clarification or additional documentation during their review. Responding quickly to any requests will help avoid further delays.

Typical Timeline for A-Class Medical Device Registration:

1. Submission and Acknowledgment:

   • Upon submission of the application, SFDA typically acknowledges receipt within a few days.

2. Document Review:

   • The SFDA will review the submitted documents (device description, safety and performance data, manufacturer certificates, etc.), which typically takes about 2 to 4 weeks for an A-class device.

3. Final Decision and Certificate Issuance:

   • After the review is complete and if the device complies with all regulatory requirements, the SFDA will issue a Medical Device Registration Certificate. This can take an additional 2 to 4 weeks after the review.

Key Considerations to Speed Up the Process:

• Ensure Complete Documentation: Ensure all required documents are accurate, complete, and comply with SFDA regulations.
• Responsive Communication: Be ready to provide any additional documents or clarifications promptly if requested by the SFDA.
• Use Local Representation: If you are an overseas manufacturer, having a local authorized representative can help navigate the process more efficiently.

In Summary:

The entire process for A-class medical device registration with the Saudi SFDA typically takes 4 to 12 weeks, depending on the completeness of the submission, the device's complexity, and the SFDA’s workload. To avoid delays, ensure that your application is thorough, and all required documents are submitted correctly.

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