United Arab Emirates | RegDesk

UAE Medical Device Regulations

The United Arab Emirates' Ministry of Health and Prevention (MOHAP) regulates medical devices in UAE.
Medical Device Definition
Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or another similar or related article: a) intended by the company and its manufacturing site to be used, alone or in combination, for human beings for one or more of the specific purpose(s) 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.
  • Indicate the sterilization process completion.
  • Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.
b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means.
Medical Device Classification System
International ClassificationRisk LevelExamples
Class ILow riskElastic bandages, Surgical gloves, Thermometers
Class IIMedium riskBlood glucose meters, Manual blood pressure monitors, Powered wheelchairs
Class IIIMedium riskInfusion pumps, X-ray machines, Dialysis machines
Class IVHigh riskHeart valves, Pacemakers, Implantable defibrillators
Approval Process
ClassificationApproval procedure
Class I
  • Appoint a local-authorized representative (AR)
  • Identify the medical device classification.
  • Applicant shall pay fees needed
  • Submit the required documentation
  • Upon approval, the Ministry of Health grants certification of registration that permits importation and sale of registered medical devices in UAE
Class II
Class III
Class IV
Additional Information
Approval timeline2 to 3 months (45 working days).
License validity period5 Years