Regulatory Support for Medical Devices in UAE
Overview of Medical Devices in UAE
The United Arab Emirates (UAE) is a leading member of the Gulf Cooperation Council (GCC) with a highly advanced healthcare system and a steadily growing market. The Ministry of Health (MoH) governs the approval process for all medical devices through its Registration and Drug Control Department. However, centralized governance and language barriers pose significant obstacles to device approvals, alongside linguistic complexities and inadequate communication channels with health authorities.
All medical devices are regulated by the Ministry of Health (MoH) via the Registration and Drug Control Department
Classification of Medical Device
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Classification |
Description |
Risk Level |
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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 |
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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 |
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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 |
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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 |
Pre-market Approval Process
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Class I |
Class II |
Class III |
Class IV |
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Appoint representative in UAE. Representative must be formally authorized. |
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Simplified registration process for Devices that have received approval from recognized country.*. |
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Complete application, CE certificate, and FSC |
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Self-declaration |
Complete DoC |
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 Registration of medical devices in the UAE must include data on effectiveness in addition to safety |
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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. |
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Validity and Post-market
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Validity |
Five years |
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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. |
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Time |
-Licenses can be acquired in nine months-Some devices may apply for an intermediate importation approval in only two months. |
SPECIAL REQUIREMENTS: Local testing is not required. All manufacturers should register their manufacturing facility as part of device registration process. Manufacturers of class III or IV devices may be subject to an onsite audit and inspection.
LOCAL FEES (Manufacturer): The Authorized Representative must be licensed by MOHAP and the facility they possessed must have one pharmacist in charge (PIC) with a License to Practice as a Pharmacist in UAE, and who is also responsible for the facility. The fees required for this license is around USD 2590.
The United Arab Emirates (UAE) is a leading member of the Gulf Cooperation Council (GCC) with a highly advanced healthcare system and a steadily growing market.
The Ministry of Health (MoH) governs the approval process for all medical devices through its Registration and Drug Control Department. However, centralized governance and language barriers pose significant obstacles to device approvals, alongside linguistic complexities and inadequate communication channels with health authorities. At RABT, our highly experienced regulatory experts are equipped to assist you with end-to-end regulatory requirements for Regulatory Due Diligence in the Middle East.
Expertise
- Regulatory Due Diligence
- Formal Medical Device Classification
- Device Registration
- UAE Authorized Representation
- Translation support
- Labeling support
- Distributor identification and qualification
- Post Approval Change Management
- License renewal and transfer
- Customs clearance
