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UAE Medical Device Regulations

Regulatory Agency

The United Arab Emirates’ Ministry of Health and Prevention (MOHAP) regulates medical devices in UAE.

Medical Device Definition

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.
    DInvestigation, 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.

Medical Device Classification System

International Classification Risk Level Examples
Class I (Is, Im) 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

Regulatory Approval Process

Classification

Approval procedure

Class I

 

 

Class II

 

 

Class III

 

 

Class IV
  • Appoint a local authorized agent.
    Register in the e-services through the Online Portal.
  • Complete the payment to meet all conditions and required fees.
  • The company registration file should be submitted at the same time as the registration files of its first product/s.
  • The applications will be processed both for expedited listing and will be issued a listing certificate, or for the review of the
  • Technical Committee which upon approval will be granted a License certificate.
  • When a device is found to have complied with all the registration requirements, the applicant will be informed to that effect.
  • Listing devices will not need Authority assessment.
  • A certificate of registration or listing shall be issued with a 5 years validity.

Additional Information

Approval timeline

2 to 3 months (45 working days).

License validity period

5 Years

Fees

Application: 100 AED ($27.23) Registration of a medical device: 5,000 AED ($1361.62)
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