IVD
Bringing an IVD to the UAE market means registering under the Emirates Drug Establishment (EDE), following its takeover from MOHAP, with a risk-based A to D classification and strong recognition of prior CE or FDA approvals.
At Taylored Consultancy Ltd, we make IVD compliance clear and stress-free. We help you classify, leverage existing approvals, and register your diagnostics so they meet UAE requirements without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your diagnostics compliant, reliable, and ready for market.
We determine the correct risk class (A to D) for your IVD 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 compile your technical file - including reference-country approval, Free Sale Certificate and ISO 13485 certificate - so your dossier is registration-ready.
We help you present analytical and clinical performance evidence to support registration.
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 IVD 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.
We help you evidence usability and human-factors work to show your IVD is safe to use.
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.
ISO 13485 - Medical devices QMS
ISO 14971 - Risk management for medical devices
ISO 15189 - Medical laboratories quality and competence
ISO 15197 - Blood glucose monitoring systems
ISO 18113 - IVD labelling and instructions for use
ISO 23640 - Stability evaluation of IVD reagents
CLSI guidelines - Laboratory method validation
IEC 61326 - EMC requirements for laboratory equipment
ISO 9001 - General quality management
IEC 62366 - Usability Engineering
