Humanitarian Use Device in Saudi Arabia

About Humanitarian Use Device

US FDA pathway for humanitarian-use devices and combination products.

How Humanitarian Use Device works in Saudi Arabia

The Saudi Food and Drug Authority (SFDA) operates a Personal Import / Unregistered Medicine pathway for named patients, typically requiring physician justification and hospital ethics-committee review.

Patients in Saudi Arabia seeking access under Humanitarian Use Device typically follow this flow: a licensed physician in Saudi Arabia issues the prescription and clinical justification, the regulator reviews and authorises, and an authorised operator coordinates import.

Documents required in Saudi Arabia

• Physician prescription and clinical-justification letter.
• Patient identification and consent.
• Country-specific NPP/personal-import form.
• Hospital or clinic attestation where required.

Typical timeline

End-to-end 2-6 weeks in most tier 1 jurisdictions. Cellular and gene therapies may require additional ethics-committee review.

Start a request

Start a request under Humanitarian Use Device in Saudi Arabia