Medical devices and in vitro diagnostic devices in the UAE are regulated by the Emirates Drug Establishment (EDE), which became the central federal authority in January 2026, replacing the Ministry of Health and Prevention (MOHAP).
CLASSIFICATION SYSTEM
Medical Devices:
- Class I
- Class II
- Class III
- Class IV
In Vitro Diagnostic Devices (IVDs):
- Class A
- Class B
- Class C
- Class D
TIMEFRAME
- Product Classification: 10 working days
- New Product Registration: 45 working days
- Manufacturer Registration License: 2 to 4 weeks
LICENSE VALIDITY
- Medical Devices: 5 years
- IVDs: 5 years
LOCAL FEES (New Application) (As of November 2022, subject to change)
- Product Classification: ~150 USD
- Product Registration: ~1500 USD
- Manufacturer Registration License: ~2800 USD
LICENSE TRANSFER
License transfer is permitted in the UAE and is treated as a major variation, subject to approval by the regulatory authority.
AUTHORIZED REPRESENTATIVE / LICENSE HOLDER
A UAE-based Authorized Representative / Local License Holder (LLH) is required to register medical devices and IVDs. The LLH must hold a valid establishment license for medical device activities. Where a medical warehouse is involved, the establishment must appoint a licensed Pharmacist-in-Charge (PIC) in accordance with local establishment licensing requirements.
ADDITIONAL INFORMATION
- The regulatory process in the UAE typically begins with a product classification procedure to determine the applicable registration pathway.
- Local testing and local clinical studies are not required.
- Manufacturers must register their manufacturing facility as part of the device registration process.
- Manufacturers of Class III and IV devices may be subject to onsite audit and inspection.
