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Medical Device Registration and Approval in Saudi Arabia

Registration in Saudi Arabia is based on companies already having approval in one of the following reference markets: Australia, Canada, Europe, Japan, and/or the USA; and registration in one of these markets is mandatory in order to register in Saudi Arabia. Per our SFDA process chart, all classes of medical devices and in vitro diagnostics require Medical Device Marketing Authorization (MDMA) approval from the SFDA. With assistance from our colleagues in Riyadh, Emergo can fully support your medical device registration in the Kingdom of Saudi Arabia (KSA).

Device classification in Saudi Arabia

Classifications in the KSA are based on the classification within the reference country on which you are leveraging your approval. How your medical device or IVD is classified in the reference market will determine how the SFDA classifies your device in Saudi Arabia.

What is needed before a device registration can be submitted?

First, if you have no local presence in the KSA, you must appoint a Saudi Arabia Authorized Representative. Your Authorized Representative must obtain an Authorized Representative License, renewable on an annual basis, in order to legally represent you in the KSA.

Submission of applications to the SFDA

Your KSA Authorized Representative is also responsible for submitting all application documents to the SFDA in order to register your device. All application documents are submitted via the Saudi Arabia's Medical Device Marketing Authorization (MDMA) system.

Documentation necessary for SFDA submissions must be provided in English, and includes the following:

  • Manufacturer and Saudi Arabia (KSA) Authorized Representative details
  • Medical device information, such as intended use and labeling/instructions for use and all marketing materials
  • Labels, IFUs, and marketing materials to be used in the KSA
  • Documents supporting your market authorization in the reference market (e.g., CE Certificate, 510(k) Letter, etc.)
  • Attestations that the device can withstand local environmental factors (e.g., heat), Declaration of Compliance to Saudi regulations, and attestation of electrical compatibility (for active devices)

Review Timelines and Certification Validity in Saudi Arabia

The SFDA allots 35 working days as its official timeframe for reviewing applications; however, actual review times are often somewhat lengthier, particularly if additional information is requested. Approvals for Class I devices and IVDs last for three years. For all other medical device classes, approvals are valid either for the remainder of the reference country approval or three years, whichever comes first.

Please contact us for more information on medical device registration in the Kingdom of Saudi Arabia.

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