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The Saudi Food and Drug Authority identified an advertisement for a medical device promoted to reduce pain and enhance joint function in cases of mild osteoarthritis that included inaccurate and exaggerated medical claims. The authority took the necessary regulatory procedures against the violating company in line with its oversight role. Competent authorities closed the associated health facility while the advertiser was referred to specialized entities for completion of legal steps. SFDA figures show such violations are subject to the Medical Devices Law and its implementing regulation.
According to an SFDA statement, penalties for these offenses can include a fine of up to 5 million Saudi riyals, temporary closure of the establishment for a period not exceeding 180 days, suspension of marketing authorization for up to one year or revocation of the license. The authority noted that the violation is considered repeated if committed within one year of the first offense, which doubles applicable sanctions in certain cases. SFDA guidelines from a 2015 directive had already compelled companies to obtain approval for medical device advertisements and avoid any misleading information about product capabilities.
The SFDA assessment found that the advertisement violated provisions requiring promotional material to align with manufacturer specifications and to refrain from content that could mislead users or the general public including online platforms. An implementing regulation published by the authority prohibits phrases open to misinterpretation and bars use of the SFDA logo in such materials. The statement added that advertisers must hold evidence to support any claims presented as superior or best in performance.
SFDA data from prior enforcement actions places medical device advertising controls as a consistent priority to protect consumers from unsubstantiated health assertions. The authority requires that advertisements directed at professionals appear in English while those for ordinary users must use Arabic. Companies seeking advertising licenses must submit documentation proving all claims meet regulatory thresholds established under the Medical Devices Law issued by royal decree.
In the announcement the authority called on the public to report suspected violations via the unified number 19999. The SFDA advised verification of all medical information and claims from official sources before making decisions related to health or treatment. A separate SFDA review of advertising rules stresses that establishments bear full responsibility for any incorrect or misleading content even after preliminary approvals.
