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

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Kuwait

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