Saudi Arabia
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

REGULATORY AUTHORITY:
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.



Interested in obtaining fast market approval for your medical device or IVD in Saudi Arabia? REQUEST A FREE QUOTE>

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
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