Regulatory Compliance for Medical Devices in the UAE
UAE Medical Device Regulations
The United Arab Emirates (UAE) regulates medical devices through the Ministry of Health and Prevention (MOHAP) under the Drug Control Department (DCD). Medical device manufacturers must comply with specific regulatory requirements to enter the UAE market to ensure patient safety and product effectiveness.
Key Regulatory Requirements for Medical Devices in the UAE:
- Authorized Representative: Foreign manufacturers must appoint a licensed UAE-based company as their Authorized Representative or Marketing Authorization Holder (MAH) to act as the official regulatory liaison.
- Manufacturing Site Registration: First-time importers must register their manufacturing site with MOHAP before submitting device registration applications.
- Device Registration: All medical devices must be registered with MOHAP before being sold or distributed.
- ISO 13485 Certification: A valid ISO 13485:2016 certificate is required for the manufacturing site registration process.
- Documentation Requirements: Manufacturers must submit technical documentation, certifications, and details about the manufacturing site for evaluation.
- Import License: An import permit from MOHAP is required before medical devices can enter the UAE market.
- License Validity: Device registration licenses are valid for five years and must be renewed before expiration.
GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
Do you need assistance with your HSA Medical Device Regulations strategy in the United Arab Emirates?
Contact us
Ministry of Health and Prevention
Medical Device Classification
The UAE follows the Global Harmonization Task Force (GHTF) classification system, categorizing devices by risk level:
Medical Devices:
- Class I – Low risk
- Class II – Low to moderate risk
- Class III – Moderate to high-risk
- Class IV – High risk
In Vitro Diagnostic Devices (IVDs):
- Class A – Low risk
- Class B – Low to moderate risk
- Class C – Moderate to high-risk
- Class D – High risk
The classification is based on intended use, duration of use, and degree of invasiveness of the device.
Registration Routes for Medical Devices in the UAE
Medical Device Registration UAE
- The registration route depends on the device classification:
- Listing Route (Low-Risk Devices)
Applicable to Class I medical devices and devices used in hospitals under professional supervision.
- A simplified evaluation process is required.
- Upon approval, a Listing Certificate is issued.
- An import permit is required to market the device in the UAE.
- Registration Route (Higher-Risk Devices)
- Site Registration: Required if a manufacturing site imports to the UAE for the first time.
- Device Registration: Includes a comprehensive evaluation by a technical committee.
- Upon approval, a registration license is issued, allowing marketing and distribution.
Qserve’s regulatory experts assist manufacturers in preparing the required documentation and building a submission package for a smooth registration process.