Medical Device Registration and Approval in Saudi Arabia

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

Medical Device Regulations and Classification in Saudi Arabia

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.

 


Other Middle East & North Africa Countries:

Algeria, Bahrain, Egypt, Israel, Jordan, Kuwait, Lebanon, Morocco, Oman, Palestine, Qatar, Tunisia, United Arabic Emirates , Yemen

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