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 ClassificationExamplesRisk Level
Class IChemistry analyzerLow
Class IIaUrine test stripsLow - Moderate
Class IIbBlood Glucose self-testingHigh - Moderate
Class IIIHIV blood analyzerHigh
Premarket Approval Process
IIIaIIbIII
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
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