Yes, the Saudi Food and Drug Authority (SFDA) may accept US Food and Drug Administration (FDA) approval as a reference for medical device and diagnostics registration in Saudi Arabia. However, similar to CE marking approval, US FDA approval alone may not be sufficient, and additional requirements or documentation may be needed to comply with SFDA regulations.
The SFDA typically requires manufacturers to submit a technical file containing information about the device, its design, manufacturing process, and performance data. This file is used to assess the safety and efficacy of the device according to SFDA regulations.
While US FDA approval indicates that a device meets FDA regulations, the SFDA may still require manufacturers to provide additional information or undergo additional testing to ensure compliance with Saudi Arabian regulations. It's important for manufacturers to consult with regulatory experts to understand the specific requirements for medical device registration in Saudi Arabia.
