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Medical Device Registration and Approval in Saudi Arabia

ANSWERED ON THIS PAGE:

  • What is the medical device registration process in Saudi Arabia?
  • How does Saudi Arabia classify medical devices and IVDs?
  • Do we need an in-country representative in Saudi Arabia?

The Saudi Food and Drug Authority (SFDA) regulates medical devices and IVDs sold and distributed in Saudi Arabia. Manufacturers must receive Medical Device Marketing Authorization (MDMA) approval from the SFDA before placing a product on the market. The SFDA meticulously reviews MDMA applications, so prepare your submission carefully to ensure a timely approval. With assistance from our colleagues in Riyadh, Emergo can fully support your medical device registration in the Kingdom of Saudi Arabia (KSA).

What is needed before submitting a device registration?

Registration in Saudi Arabia is based on prior approval in one of the following reference markets: Australia, Canada, Europe, Japan, or the USA; registration in one of these markets is mandatory to register in Saudi Arabia. Generally, your medical device or IVD classification in the reference market will determine how the SFDA classifies your device.

You must also appoint a Saudi Arabia Authorized Representative if you do not have an office or entity in Saudi Arabia. Your Authorized Representative must obtain an Authorized Representative License, which is renewable on an annual basis, to legally represent you in the KSA. Your KSA Authorized Representative is also responsible for submitting all application documents to the SFDA to register your device.

Submission of applications to the SFDA

All application documents are submitted via the Saudi Arabia's Medical Device Marketing Authorization (MDMA) system. SFDA submissions must be provided in English, and includes the following documentation:

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

Emergo helps with medical device approvals in Saudi Arabia

Emergo is an international consulting firm that works exclusively for medical device and IVD companies. Our experienced team is equipped to assist with all aspects of the SFDA registration process. Here’s what we can do:

  • Help you identify the best reference country to leverage for your SFDA registration
  • Act as your Authorized Representative; prepare and authenticate AR license
  • Communicate with SFDA on your behalf as your Authorized Representative
  • Prepare and submit your Medical Device Marketing Authorization (MDMA) application
  • Prepare and submit authorization and AR license renewals or transfers
  • Assist with import authorization documentation

With offices in the Middle East, Europe, North America, and beyond, Emergo can help you start selling in Saudi Arabia and in markets around the world.

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

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Common Questions

How long is the SFDA review process?
The SFDA allots 35 working days as its official timeframe for reviewing applications; however, actual review times are often longer, particularly if additional information is requested.

When do SFDA approvals expire?
Approvals for Class I self-certified devices and general IVDs last for three years. For all other medical device classes, approvals are valid either for the remainder of the reference country approval, if there is an explicit expiration date; or three years if the reference country market authorization is considered by the SFDA to be open ended.

What is the Gulf Countries Council (GCC)?
The GCC (Cooperation Council for the Arab States of the Gulf, previously known as the Gulf Cooperation Council) is a political and economic union that comprises the six Arab states of the Persian Gulf: Saudi Arabia, the UAE, Bahrain, Oman, Kuwait, Qatar, plus Yemen. The GCC developed a group purchasing program that covers all member states, offering significant opportunity to foreign manufacturers. Our colleagues in Riyadh provide consulting and representation support with elements of the tender process.