Kuwait
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

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.



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