SFDA: Fines Up to SAR 5M for Misleading Device Ads

Regulatory authorities have flagged a misleading medical device advertisement and warned that such violations may incur administrative fines of up to SAR 5,000,000, alongside other sanctions. The move is part of ongoing oversight of medical device advertising across the Kingdom.

The flagged case involved a medical device promoted for reducing pain and improving joint function in mild osteoarthritis. The advertisement carried inaccurate and exaggerated medical claims that breached the advertising rules for medical devices and supplies. In response, legal procedures were initiated against the responsible company, the concerned healthcare facility was closed by competent authorities, and the advertiser was referred to complete legal action.

Under the Medical Devices and Supplies Law and its Implementing Regulations, penalties can go beyond financial fines. They include temporary closure of the healthcare or commercial facility for up to 180 days, a ban on engaging in any medical device–related activities for up to 180 days, and revocation of the establishment's license or the relevant marketing authorization.

Advertising approval required

Before any medical device can be advertised, an Approval of Medical Device Advertisement (AMDA) is required. The fee is SAR 3,000 for advertisements directed to the general public and SAR 6,000 for those aimed at healthcare professionals.

For residents and shoppers, the message is clear: be cautious of exaggerated health claims about devices promising pain relief or improved joint function. Consumers can report suspected violations through the unified phone number 19999. Enforcement reports through 2025–2026 show continued fines, license suspensions, and the suspension of professional licenses for practitioners promoting products with unapproved indications or misleading safety and efficacy claims.

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