United Arab Emirates Medical Device Regulations

Agency

All medical devices are regulated by the Ministry of Health (MoH) via the Registration and Drug Control Department

Medical Device Definition

"Medical device" means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article (a) intended by the manufacturer 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 or handicap; investigation, replacement, modification, or support of the anatomy of a physiological process; Supporting or sustaining life; Control of conception; Disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body and (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.

Classification of Medical Device

Classification	Description	Risk Level
Class I	Those needing the lowest level of regulation because of low risk to the patient except sterile products. They are subject to the General Controls requirements. Declaration of conformity is accepted from the legal manufacturer.	Low
Class II	Invasive in their interaction with the human body, but the methods of invasion are limited to natural body orifices. The category may also include therapeutic devices used in diagnosis or in wound management	Low - Moderate
Class III	They are either partially or totally implantable within the human body, and may modify the biological or chemical composition of body fluids.	High - Moderate
Class IV	Require design/clinical trial reviews, product certification and an assessed quality system involving clinical trials. These devices affect the functioning of vital organs and/or life-support systems. Devices are usually invasive, life-sustaining, life-supporting, or is used "in preventing impairment of human health or if the device presents a potential unreasonable risk of illness or injury".	High

Premarket Approval Process

Class I	Class II	Class III	Class IV
Appoint representative in UAE. Representative must be formally authorized.
Simplified registration process for Devices that have received approval from recognized country.*.
Complete application, CE certificate, and FSC
Self-declaration	Complete DoC
Â Registration of medical devices in the UAE must include data on effectiveness in addition to safety
If the safety and effectiveness is established and the MoH approves the registration, certificate of registration is granted and permits the importation/sale of the registered medical device in UAE.

Validity and Postmarket

Validity	Five years
Post Market Surveillance	Medical Device Vigilance System must be implemented and maintained: Maintain distribution procedures record. Maintain adverse incident reporting procedures and records. Have procedures to promptly and effectively execute investigations and recalls of defective medical devices.
Time	-Licenses can be acquired in nine months-Some devices may apply for an intermediate importation approval in only two months.

Notes

Documents may be submitted in English

* Recognized countries: Europe, the US, Australia, Canada or Japan

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