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: November 2023

Medical Device Regulations and Classification in Kuwait

REGULATORY AUTHORITY: The Pharmaceutical & Herbal Medicines & Registration & Control Administration Department of the Ministry of Health (MOH).

CLASSIFICATION SYSTEM: Class A, Class B, Class C, Class D

Classes A, B, C, and D correspond to Class I, IIa, IIb, and III as per European Medical Device regulation.

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: Yes.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative is required to register medical devices in Kuwait.

Other Middle East & North Africa Countries: Algeria,Bahrain,Egypt,Israel,Jordan,Lebanon,Morocco,Oman,Palestine,Qatar,Saudi Arabia,Tunisia,United Arabic Emirates,Yemen

 

JUST SAY WHEN!

Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?

And, in less than a minute, you can start your device-specific registration application and a complete country-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform. You can start your product registration right now!

Ready to Get Started?