UAE Medical Device Regulations

Regulatory Agency

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 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

Regulatory Approval Process

Classification	Approval procedure
Class I	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.
Class II
Class III
Class IV

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)

Need More Information

RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.

Get the report