Saudi Arabia is one of the fastest-growing healthcare markets in the Middle East. For medical device manufacturers, entering this market means big opportunities—but it also comes with strict rules set by the Saudi Food and Drug Authority (SFDA). To sell devices successfully, companies must go through Saudi Arabia medical device registration, a process designed to ensure patient safety and product quality.

Who Regulates Medical Devices in Saudi Arabia?

The SFDA is the sole authority responsible for reviewing and approving all medical devices in the Kingdom. Its regulations are closely aligned with international standards, but with added requirements specific to Saudi Arabia. Devices are registered under two main pathways:

  • MDNR (Medical Device National Registry): For Class I, low-risk devices that are non-sterile and non-measuring. This is a faster, lighter process.

  • MDMA (Medical Device Marketing Authorization): For medium- to high-risk devices (Classes II–IV). This requires detailed technical files, safety data, and a more thorough review.
    While MDNR approvals can be completed within a few days, MDMA reviews may take a month or more. Both are valid for three years.

Steps to Register Medical Devices in Saudi Arabia

  1. Appoint a Local Authorized Representative
    If you don’t have a presence in Saudi Arabia, you’ll need a local representative licensed by the SFDA. This is mandatory for foreign manufacturers.

  2. Classify Your Device
    Devices are grouped by risk level (A to D). Choosing the correct class is critical, as it determines whether you go through MDNR or MDMA.

  3. Prepare Documentation
    SFDA requires a full set of documents: product description, labeling in Arabic and English, risk analysis, clinical data, and proof of ISO 13485 certification.

  4. Submit via GHAD Portal
    All applications are filed through SFDA’s online GHAD system. Fees are paid at submission, and the SFDA may request clarifications during review.

  5. Maintain Compliance Post-Approval
    Once registered, companies must renew their licenses, report incidents, and ensure product quality throughout the device’s life cycle.

Why Expert Support Helps

Regulatory requirements can be complex—especially for global companies unfamiliar with Arabic documentation, local laws, or the SFDA’s expectations. That’s why many manufacturers work with regulatory partners who specialize in Saudi submissions. For example, Saudi Arabia medical device registration services from Freyr Solutions cover everything from classification and dossier preparation to Authorized Representative support and lifecycle management. With expert guidance, companies avoid delays and gain faster market access.

Conclusion

The Saudi healthcare market is booming, but success depends on meeting regulatory standards. Understanding the basics of medical device registration in Saudi Arabia—classification, documentation, and submission—is key to entering the market smoothly. By combining clear knowledge of SFDA requirements with expert support, manufacturers can register their devices efficiently and bring innovative healthcare solutions to patients across the Kingdom.

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