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Medical Device Registration and Approval in Kuwait
General country-specific regulatory information is provided on this page for medical device registration and approval in Kuwait.
Last updated on November 24th, 2021.
Medical Device Regulations and Classification in Kuwait
REGULATORY AUTHORITY: Medical devices are regulated by the Drug and Food Control Ministry of Health.
CLASSIFICATION SYSTEM: Classification follows the EU model of risk-based classification.
Medical Devices: Classification follows the EU model of risk-based classification.
IVD Devices: Classification follows the EU model of risk-based classification.
TIMEFRAME: The approval process typically takes 6-8 weeks.
Class I: The approval process typically takes 6-8 weeks.
Class II: The approval process typically takes 6-8 weeks.
Class III: The approval process typically takes 6-8 weeks.
Class IV: The approval process typically takes 6-8 weeks.
IVD Devices: The approval process typically takes 6-8 weeks.
SPECIAL REQUIREMENTS:
Audits: There are no special requirements for audits.
Technical Local Tests: None
Clinical Evaluation/studies: None
LOCAL FEES:
Application review fees: Not applicable.
Manufacturer registration: Not applicable.
LICENSE VALIDITY: Licenses are valid for 5 years in Kuwait.
LICENSE TRANSFER: Not applicable in Kuwait.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative is required to register medical devices in Kuwait.
For detailed device-specific compliance information for each market, including Kuwait, to expedite the preparation of your medical device or IVD registration application.
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