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Kuwait Medical Device Regulations

Agency
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:
  • 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.
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.
Medical Device Classification System
International Classification Risk Level Examples
Class A Low risk Bandages, tongue depressor
Class B low to Moderate risk Hypodermic needles, suction equipment
Class C Moderate to High risk Lung ventilator, bone fixation plate
Class D High risk Heart valves, implantable defibrillator
Approval Process
Classification Approval procedure
Class A
  • Appoint a local authorized representative in Kuwait.
  • Apply for registration with the required supporting documents.
  • Certification will be issued after registration approval.
Class B
Class C
Class D
Additional Information
Approval timeline 2 to 6 months approx.
License validity period 5 years
Fees New Registration :- $82
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