UAE Medical Device Regulations

Medical Device: means any instrument, apparatus, appliance, material, or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

Diagnose, prevention, monitoring, treatment, or alleviation of disease.
Diagnosis, monitoring, treatment, alleviation of, or compensation for injury or handicap.
Investigation, replacement, or modification of the anatomy or a physiological process, control of conception. And  does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means but which may be assisted in its function by such means.

Invasive Device: a device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.

Surgically Invasive Device: means an invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation.

Note: Devices other than those referred to in the previous subparagraph which produce penetration other than through an established body orifice shall be treated as surgically invasive devices.