Medical Device Regulation in United Arab Emirates
The United Arab Emirates regulates medical devices through the Ministry of Health and Prevention (MOHAP) and the Emirates Authority for Standardization and Metrology (ESMA). The UAE has been modernizing its regulatory framework to align with international best practices, requiring product registration and market surveillance for all medical devices sold in the country.
Recent Regulatory Updates
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UAE mandates multiple distributors per medical product
EDE signs two MoUs and launches Organ-on-Chip project
UAE launches Emirates Drug Establishment at WHX 2026
Sources Tracked by Qalico
Qalico continuously monitors 0 references across guidelines, regulations, and standards for United Arab Emirates.
Device Classification
The UAE uses a risk-based classification system aligned with IMDRF principles. Class A devices are low risk (e.g., bandages, tongue depressors). Class B devices are low-moderate risk (e.g., hypodermic needles, surgical gloves). Class C devices are moderate-high risk (e.g., ventilators, bone fixation plates). Class D devices are high risk (e.g., heart valves, implantable defibrillators).
Official classification guidance →Official Regulatory Bodies
Official Guidance Documents
Standards & Key Principles
Applicable Standards
Key Principles
- All medical devices must be registered with MOHAP before being placed on the UAE market.
- Manufacturers must appoint an authorized representative based in the UAE.
- Product registration requires a valid ISO 13485 certificate and proof of market approval in a recognized reference country.
- Post-market vigilance reporting is mandatory for adverse events and field safety corrective actions.
- The UAE recognizes approvals from certain reference regulatory authorities including the FDA, EU notified bodies, Health Canada, and TGA.
Pre-Market Requirements
All medical devices must be registered with MOHAP. The application requires technical documentation, ISO 13485 certification, a certificate of free sale from the country of origin, and proof of approval from a recognized reference authority.
Foreign manufacturers must appoint a UAE-based authorized representative who acts as the legal entity responsible for regulatory compliance in the country.
Higher-risk devices (Class C and D) require conformity assessment certificates from recognized bodies. The UAE accepts CE marking and FDA clearance as supporting evidence.
Device labels must include Arabic language information, manufacturer details, intended use, and any relevant warnings or storage conditions.
Post-Market Requirements
Manufacturers and authorized representatives must report serious adverse events and field safety corrective actions to MOHAP within prescribed timeframes.
Device registrations must be renewed periodically. Renewal applications require updated documentation and evidence of continued compliance.
MOHAP conducts market surveillance activities including inspections, sample testing, and review of post-market data to ensure ongoing device safety and performance.
International Recognition & Reliance
The UAE participates in the GCC medical device harmonization efforts, facilitating mutual recognition among Gulf states.
The UAE aligns its classification and regulatory framework with IMDRF guidelines to ensure international compatibility.