SAMD
In the UAE, software with a medical purpose is regulated as a medical device, now under the Emirates Drug Establishment (EDE) following its takeover from MOHAP. Classification follows a risk-based A to D system, and registration leans heavily on recognising prior CE or FDA approvals.
At Taylored Consultancy Ltd, we make software compliance clear and stress-free. We help you classify, leverage existing approvals, and register your software so it meets UAE requirements without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your software safe, compliant, and ready for market.
We confirm whether your software is a medical device and determine its risk class (A to D) under the UAE's IMDRF-aligned system.
We map out the most efficient route, making the most of existing CE marking or FDA clearance that the UAE recognises.
We help you assemble software lifecycle documentation (IEC 62304) and a registration-ready technical file.
We build your risk management file, including software and AI/ML-specific risks.
We review your labelling and instructions for use to meet UAE Arabic and English requirements.
We handle registration through the EDE / MOHAP portal so your software is correctly listed.
Overseas manufacturers need a UAE-licensed Local Authorised Representative. We help you put the right arrangement in place.
We help you implement a QMS to ISO 13485, required for UAE registration.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
EN 62304 / IEC 62304 - Medical device software lifecycle
IEC 82304-1 - Health software products
IEC 62366-1 - Usability / human factors engineering
ISO 14971 - Risk management for medical devices
ISO 13485 - Medical devices QMS
ISO/IEC 42001 - AI management systems
ISO 9001 - General quality management
