Fines Up to SAR 5M for Misleading Device Ads

Misleading advertisements for medical devices in Saudi Arabia can now expose violators to administrative fines of up to SAR 5,000,000, alongside a range of other penalties currently being enforced in 2026 under the Medical Devices and Supplies Law and its implementing regulation.

The warning follows a recent case in which an advertisement for a medical device marketed to reduce pain and improve joint function in cases of mild osteoarthritis was flagged for carrying inaccurate and exaggerated medical claims that breach the promotional rules for medical devices and supplies.

Beyond the financial penalty, violating establishments may face temporary closure for up to 180 days, suspension of a device's marketing authorization for up to one year, and even full revocation of that authorization or of the establishment's license. Businesses may also be banned from practicing any activity related to medical devices and supplies for up to 180 days.

Penalties Can Double for Repeat Offenders

The fine, temporary closure, marketing suspension, and activity ban may all be doubled if the same violation is repeated within the period defined by the regulation. The rules explicitly treat the use of false information to promote medical devices, or within advertisements, as a punishable violation.

For residents and shoppers, the message is clear: claims that a device dramatically eases pain or restores joint function should be treated with caution unless properly authorized. Members of the public can report suspected advertising or device-related violations through the unified phone number 19999 and other official communication channels, a reporting route that remains active in 2026.

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