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:
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.
- 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.
Medical Device Classification System
|International Classification||Risk Level||Examples|
|Class I||Low risk||Elastic bandages, Surgical gloves, Thermometers|
|Class II||Medium risk||Blood glucose meters, Manual blood pressure monitors, Powered wheelchairs|
|Class III||Medium risk||Infusion pumps, X-ray machines, Dialysis machines|
|Class IV||High risk||Heart valves, Pacemakers, Implantable defibrillators|
|Approval timeline||2 to 3 months (45 working days).|
|License validity period||5 Years|