Humanitarian Use Device in Kuwait
How the humanitarian use device pathway operates in Kuwait.
About Humanitarian Use Device
US FDA pathway for humanitarian-use devices and combination products.
How Humanitarian Use Device works in Kuwait
Kuwait's Ministry of Health operates a Personal Import pathway for specialty drugs not registered locally, typically through a hospital pharmacy with physician attestation.
Patients in Kuwait seeking access under Humanitarian Use Device typically follow this flow: a licensed physician in Kuwait issues the prescription and clinical justification, the regulator reviews and authorises, and an authorised operator coordinates import.
Documents required in Kuwait
- 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 2 jurisdictions. Cellular and gene therapies may require additional ethics-committee review.