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