MedStandard

State of Kuwait

State Food and Drug Supervision Authority, Kuwait Ministry of Health

Ministerial decree on the registration and release of medical devices

5 years

3-4 months

Class 1 and 2A

5–6 months

Class 2B and 3

English, Arabic

country resident

Regulatory process for medical devices in Kuwait:

01

Medical device classification determination

02

Appointment of an authorized representative

03

Completion of an application form with required documents

04

Submission of the application to the regulatory authority

05

Upon approval, the device can be marketed in Kuwait

Final price and terms procedures will be calculated according to your request