Kuwait Medical Device Regulations

Agency
All medical devices are regulated by the MInistry of Health (MOH) Food & Drug Control Department
Classification of Medical Device
International Classification Examples Risk Level
Class I Chemistry analyzer Low
Class IIa Urine test strips Low - Moderate
Class IIb Blood Glucose self-testing High - Moderate
Class III HIV blood analyzer High
Premarket Approval Process
I IIa IIb III
Appoint a local authorized representative (AR) in Kuwait to submit application (required).
Fill out application form and submit all required documents (listed below).
If approved, applicant will receive a registration certificate
List of Required Documents
  • Application
  • CE certificate copy
  • CFS
  • Quality Management System
  • User manual and Certificate of composition
  • Declaration of conformity (DoC)
  • Certificate of free sale