UAE Medical Device Classification Explained for Manufacturers

Why Classification Matters?

Before registration, products must be classified according to risk level under MOHAP regulations.

Classification Overview

Class I: Low risk devices
Class II: Moderate risk
Class III: High risk
Class IV: Very high risk / implantables

Higher classes require more extensive safety and clinical documentation.

Key Documentation Differences

Class Documentation Depth Clinical Data

I Basic technical file Usually not required
II Expanded technical file Sometimes required
III Full technical dossier Required
IV Extensive safety & efficacy Mandatory