Medical Device Registration
- Ensure Compliance with MoHAP
- Access UAE Healthcare Market
- Simplify Import and Distribution
- Meet Global Quality Standards
- Gain Consumer and Business Trust
Medical device registration in the UAE is governed by the Ministry of Health and Prevention (MOHAP), ensuring compliance with stringent regulatory requirements. Device manufacturers must meet standards for classification, safety, and quality to obtain a certificate of registration.
Recent updates align the process with global practices, emphasizing post-market surveillance and streamlined product registration.
Appoint a licensed LAR in the UAE to handle the registration process and communicate with MOHAP on your behalf.
Collect required documents such as the manufacturing facility certificate, certificate of free sale (CFS), product classification details, technical documentation, quality certificates, and post-market surveillance plan.
Classify your device into one of four categories (Class I, IIa, IIb, or III) based on its risk level, which will determine the registration process.
Submit the registration application with all required documents through the MOHAP online portal.
Pay the applicable registration and classification fees through the MOHAP payment system.
MOHAP reviews the application and documents, which may take up to 45 working days. Additional information may be requested.
Step-by-Step Process for Registering Medical Equipment in the UAE
Requirements for Registering Medical Equipment in the UAE
1. Manufacturer and Representation Requirements
Local Authorized Representative (LAR): Foreign manufacturers must appoint a licensed LAR in the UAE to handle registration.
Manufacturing Facility Certificate: Proof of manufacturing registration from the country of origin.
Certificate of Free Sale (CFS): Confirms the product is legally sold in its home country and attested by the UAE Embassy.
Agency Agreement: Contract between the manufacturer and LAR for registration and market entry.
2.Technical and Compliance Requirements
Product Classification: Devices must be categorized based on risk level (Class I, IIa, IIb, III).
Technical Documentation: Submit details like design, labels, usage, safety data, and manuals..
Quality Certificates: Provide EC Declaration of Conformity or ISO 13485:2016..
Certificate of Analysis (COA): Verify specifications and performance..
Post-Market Plan: Ensure safety checks after registration, especially for high-risk devices.
Fee Payment: Pay all fees during the submission process.
3.Classification of Medical Devices in the UAE
Class I (Low Risk): Simple devices like bandages or thermometers, requiring basic documents.
Class IIa (Low to Moderate Risk): Devices like dental tools or imaging systems, needing extra safety checks.
Class IIb (Moderate to High Risk): Surgical tools or implants, requiring detailed data and testing.
Class III (High Risk): Critical devices like pacemakers or ventilators, needing strict clinical evidence.