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