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 Department for Unclassified and Medical Devices under the Ministry of Health.
CLASSIFICATION SYSTEM: Classification follows the EU model of risk-based Classes I, IIa, IIb, III, and IV.
TIMEFRAME: The approval process typically takes 4-6 weeks.
AUTHORIZED REPRESENTATIVE: An authorized representative is required to register medical devices in Kuwait.
Last updated on March 17 2015.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.
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