Special Access & Enforcement

Novel device exemptions, compassionate use, clinical investigations, radiation-emitting device permits, and SFDA enforcement powers.

📄️Compassionate Use & Novel Device Exemptions

SFDA provisions for compassionate use supply and exemptions for novel or innovative devices that do not yet have full MDMA.

Requirements for conducting clinical investigations (clinical trials) for medical devices in Saudi Arabia under SFDA oversight.

SFDA enforcement powers — inspections, import alerts, market withdrawal, and penalties for non-compliance with the Medical Devices Law.