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.

Other Middle East & North Africa Countries:

Algeria, Bahrain, Egypt, Israel, Jordan, Lebanon, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Tunisia, United Arabic Emirates , Yemen

 

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