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.

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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