Kuwait Medical Device Regulations

Regulatory Agency

The Ministry of Health (MOH) - Drug & Food Control Administration regulates medical devices in Kuwait.

Medical Device Definition

Medical Device: 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

Regulatory Approval Process

Classification	Approval procedure
Class A	-Appoint a local authorized representative in Kuwait. -Apply for registration with the required supporting documents. -Additional documents might be required or samples for analysis during or after product registration. -Certification will be issued after registration approval.
Class B
Class C
Class D