The Ministry of Health (MOH) - Drug & Food Control Administration regulates medical devices in Kuwait.
Medical Device Definition
A medical device in Kuwait means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or another similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of:
Providing information by means of in vitro examination of specimens derived from the human body, and does not achieve its primary intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
- Diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury.
- Investigation, replacement, modification, or support of the anatomy, or of a physiological process.
- Supporting or sustaining life.
- Control of conception.
- Disinfection of medical devices.
Medical Device Classification System
||Bandages, tongue depressor
||low to Moderate risk
||Hypodermic needles, suction equipment
||Moderate to High risk
||Lung ventilator, bone fixation plate
||Heart valves, implantable defibrillator
||2 to 6 months approx.
|License validity period
||New Registration :- $82