Saudi authority takes legal action on medical device violations

The authority urged all commercial entities to comply with standards to ensure product safety and avoid legal consequences. (SPA)
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Updated 08 December 2025
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Saudi authority takes legal action on medical device violations

RIYADH: The Saudi Food and Drug Authority has referred a commercial facility to the Public Prosecution for distributing and selling medical devices for purposes other than their intended use without obtaining the authority’s mandatory pre-approval.

This pre-approval ensures quality standards and safe usage, and the facility’s actions breach the Medical Devices and Supplies System, the Saudi Press Agency reported on Monday.

The authority stressed its zero-tolerance stance toward violations that endanger consumer safety. Under the law, offenders may face up to 10 years in prison or fines of up to SR10 million ($2.67 million).

The authority reaffirmed its commitment to strict regulatory enforcement and urged all commercial entities to comply with standards to ensure product safety and avoid legal consequences. It also encouraged the public to report violations via the toll-free number 19999.