| 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 |
Kuwait
Medical Device Regulations
Agency
All medical devices are regulated by the MInistry of Health (MOH) Food & Drug Control Department
Classification of Medical Device
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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