MEDICAL DEVICE REGISTRATION AND APPROVAL IN Kuwait

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
Last update: May 2024

Medical Device Regulations and Classification in Kuwait

REGULATORY AUTHORITY: The Ministry of Health (MOH) oversees medical device regulation through the Pharmaceutical & Herbal Medicines Registration & Control ADMINISTRATION).

CLASSIFICATION SYSTEM:  Kuwait classifies Medical Devices and IVD into one of four classes: A, B, C, D.

TIMEFRAME:

6 to 8 weeks

SPECIAL REQUIREMENTS:

Audits: There are no special requirements for audits.

Technical Local Tests: Sampling and local testing may be required

Clinical Evaluation/studies: None

LOCAL FEES:

Application review fees: Not applicable.

Manufacturer registration: Not applicable.

LICENSE VALIDITY: 5 years

LICENSE TRANSFER: Yes.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER:

A local license holder is required

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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