Medical devices are regulated by the Saudi Food & Drug Administration or SFDA. CLASSIFICATION SYSTEM:
The SFDA classifies devices according to EU risk-based model into Classes I, IIa, IIb, III, and IV. TIMEFRAME:
Approval typically takes between 30 and 60 days after files have been submitted to the authorities. LICENSE VALIDITY:
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. AUTHORIZED REPRESENTATIVE:
An authorized representative is required to register medical devices in Saudi Arabia. ADDITIONAL INFORMATION:
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