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.

Last updated on January 29 2015.



ARE YOU INTERESTED IN REGISTRATION 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
latest news
  • Feb 21 2018
    REGULATORY UPDATE - TECRES MEDICAL

    Saudi Arabia: Tecres Medical's Rally Bone Cements were approved for sale with LICENSALE.COM®. ...

    Read More
  • Feb 19 2018
    REGULATORY UPDATE - LUMINEX

    Brazil: Luminex's xTAG Cystic Fibrosis 71 Kit v2 was approved for sale with LICENSALE.COM®. ...

    Read More
  • Feb 1 2018
    REGULATORY UPDATE - LEXMARK

    UAE: Lexmark's Media Writer, PACS Scan and EHR Gateway were approved for sale with LICENSALE.COM®. ...

    Read More
  • Jan 30 2018
    REGULATORY UPDATE - SYNTHETIC MR

    USA: Synthetic MR's SyMRI Neuro was approved for sale with LICENSALE.COM®. ...

    Read More
  • Jan 9 2018
    REGULATORY UPDATE - NOVASIGHT

    EU: Novasight's Eyeswift was approved for sale with LICENSALE.COM®. ...

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP