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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Kuwait, to expedite the preparation of your medical device or IVD registration application.
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.
Last updated on March 22, 2019.
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