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Medical devices are regulated by the Saudi Food & Drug Administration or SFDA.
The SFDA classifies devices according to EU risk-based model into Classes I, IIa, IIb, III, and IV.
Approval typically takes between 30 and 60 days after files have been submitted to the authorities.
For Class 1 devices, licenses are valid for 3 years. For all other classes of devices, license validity in Saudi Arabia depends on the validity of the CE mark or relevant certificate from country of origin.
An authorized representative is required to register medical devices in Saudi Arabia.
Establishment licensing is a separate process, which should be conducted before registering a product.
Last updated on January 29 2015.
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For more information on registration in Saudi Arabia, check out the following articles on our blog:
Country at a Glance: Saudi Arabia
5 Big Questions (& Answers): Saudi Arabia's New Official Regulatory System