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

Obtain approval in

Kuwait

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