The timelines for the review and approval of medical devices in Saudi Arabia can vary depending on several factors, including the class of the device, the completeness of the submission, and the workload of the Saudi Food and Drug Authority (SFDA). However, the SFDA aims to complete the review process within a reasonable timeframe.
In general, the review and approval process for a medical device in Saudi Arabia can take anywhere from a few months to over a year. For lower-risk devices, such as Class I devices, the process may be faster, while higher-risk devices, such as Class III devices, may require more time for review.
It's important for manufacturers to submit a complete and accurate application to the SFDA to avoid delays in the review process. Additionally, manufacturers can expedite the review process by responding promptly to any requests for additional information or clarification from the SFDA.
Overall, while the exact timelines can vary, manufacturers should plan for a review and approval process that may take several months to ensure timely market access for their medical devices in Saudi Arabia.
