Overview of Medical Devices
in the 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.
📋 Key Regulatory Highlights
Registration and Drug Control Department
Licenses can be acquired in nine months
Some devices may apply in only two months
Authorized Representative License — approx. USD 2,590
Classification of Medical Devices in UAE
All medical devices are regulated by the Ministry of Health (MoH) via the Registration and Drug Control Department.
✅ Class II
✅ Class III
✅ Class IV
⚠️ Key Requirement: Centralized governance and language barriers pose significant obstacles to device approvals, alongside linguistic complexities and inadequate communication channels with health authorities.
UAE Medical Device Registration Process
Registration of medical devices in the UAE must include data on effectiveness in addition to safety. If safety and effectiveness is established and the MoH approves the registration, a certificate of registration is granted permitting importation and sale in the UAE.
Appoint a Representative in UAE
Appoint a representative in UAE. The representative must be formally authorized. The Authorized Representative must be licensed by MOHAP and the facility must have one pharmacist in charge (PIC) with a License to Practice as a Pharmacist in UAE.
All Classes
Class I — Self-Declaration & DoC
Simplified process for Class I devices. Complete Declaration of Conformity (DoC). Self-declaration is accepted from the legal manufacturer.
Class I
Class II — Simplified Registration
Simplified registration process for devices that have received approval from a recognized country. Complete application, CE certificate, and FSC (Free Sale Certificate).
Class II
Manufacturing Facility Registration
All manufacturers should register their manufacturing facility as part of the device registration process. Manufacturers of Class III or IV devices may be subject to an onsite audit and inspection.
All Classes
MoH Review & Registration Certificate
If safety and effectiveness is established and the MoH approves the registration, a certificate of registration is granted and permits the importation and sale of the registered medical device in UAE.
Approval
Post-Market Surveillance
Medical Device Vigilance System must be implemented and maintained: maintain distribution procedures record, adverse incident reporting procedures and records, and procedures to promptly execute investigations and recalls of defective medical devices.
Post-Market
License Validity & Special Requirements
Key timelines, validity periods, and special requirements for medical device registration in the UAE.
Validity & Timelines
License duration and approval timelines for UAE medical device registration
License validity — Five years
Licenses can be acquired in nine months
Some devices may apply for an intermediate importation approval in only two months
Authorized Representative license fee — approximately USD 2,590
Facility must have one pharmacist in charge (PIC) with a License to Practice as a Pharmacist in UAE
Special Requirements
Additional requirements applicable to all manufacturers registering in the UAE
Local testing is not required
All manufacturers should register their manufacturing facility as part of the device registration process
Manufacturers of Class III or IV devices may be subject to an onsite audit and inspection
Registration must include data on effectiveness in addition to safety
Authorized Representative must be licensed by MOHAP
RABT Global’s UAE Regulatory Services
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.
Regulatory Due Diligence
Comprehensive regulatory due diligence support for medical device manufacturers entering the UAE market.
Formal Medical Device Classification
Expert classification of medical devices under UAE MoH’s four-class risk-based classification framework.
Device Registration
End-to-end medical device registration management with the UAE Ministry of Health Registration and Drug Control Department.
UAE Authorized Representation
RABT Global acts as your formally authorized UAE representative for all MoH regulatory filings and communications.
Translation Support
Professional translation support to address language barriers and ensure compliant documentation submission to UAE health authorities.
Labeling Support
Labeling review and development to meet UAE MoH regulatory requirements for medical device market authorization.
Distributor Identification and Qualification
Identification and qualification of local distributors for compliant product distribution across the UAE market.
Post Approval Change Management
Management of post-approval changes and notifications to the UAE MoH following initial device registration.
License Renewal and Transfer
Timely management of five-year license renewals and license holder transfers with the UAE Ministry of Health.
Customs Clearance
Support for customs clearance processes to facilitate compliant importation of registered medical devices into the UAE.