March 07, 2025

Compiling a Medical Device Master File (DMF) is a crucial step in the registration process for medical devices in the UAE. This document serves as a comprehensive repository of technical and regulatory information, ensuring compliance with the UAE's stringent regulatory requirements.

This guide provides a detailed approach to preparing a DMF for the UAE market, incorporating key regulatory guidelines for better understanding.

What is a Medical Device Master File?

A Medical Device Master File (DMF) is a detailed document that provides comprehensive information about the design, manufacturing, processing, packaging, and storage of a medical device. It is essential for demonstrating the quality, safety, and efficacy of medical devices to regulatory authorities in the UAE.

Key Components of a Medical Device Master File

  1. Device Description and Specifications
  • Detailed information about the device, including its design, components, intended use, and performance characteristics.
  • Engineering drawings and schematics.
  • Material specifications and justifications for material selection.
  1. Labelling and Instructions for Use (IFU)
  • Comprehensive guidance on the safe and effective use of the device.
  • Label artwork and translated instructions (Arabic & English as per UAE requirements).
  1. Design and Manufacturing Information
  • Detailed descriptions of the manufacturing process and key production steps.
  • Quality control and assurance protocols, ensuring product consistency and compliance.
  1. Risk Management Documentation
  • Summaries of risk assessments and mitigation strategies in accordance with ISO 14971.
  • Information on Serious Adverse Events (SAE) and Field Safety Corrective Actions (FSCA).
  1. Verification and Validation Information
  • Results of functional tests, biocompatibility studies, and validation studies.
  • Clinical evaluation reports (CER) demonstrating safety and performance in compliance with UAE regulations.
  1. Post-Market Surveillance (PMS) Information
  • Plans for monitoring the device’s performance aftermarket release.
  • Data from post-market studies and complaints handling processes.

UAE Regulatory Framework for Medical Devices

Regulatory Authority

The Ministry of Health and Prevention (MOHAP) is the primary regulatory body responsible for overseeing medical device registration in the UAE. MOHAP ensures that all medical devices meet safety, performance, and quality standards in accordance with international regulations.

Classification of Medical Devices

Medical devices are classified based on risk levels, following a risk-based classification system:

  • Class I: Low-risk devices (e.g., bandages, thermometers).
  • Class II: Moderate-risk devices (e.g., diagnostic instruments, infusion pumps).
  • Class III: High-risk devices (e.g., ventilators, heart monitors).
  • Class IV: Critical devices (e.g., implantable devices, pacemakers).

Required Documentation for Medical Device Registration in UAE

Manufacturers must submit the following documents to MOHAP for device registration:

  1. Application Form – Detailed information about the device, including classification, intended use, and manufacturer details.
  2. Product Documentation – Labels, user manuals, technical data, and IFU demonstrating compliance with safety and performance requirements.
  3. Certificate of Free Sale (CFS) – Proof that the device is legally marketed in another country (e.g., US FDA approval, EU CE marking).
  4. Quality Management System (QMS) Documentation – Compliance with ISO 13485:2016 or equivalent quality certification.
  5. Power of Attorney (PoA) – Authorization for a local UAE representative to handle the registration process.
  6. Conformity Assessment Documents – Evidence of compliance with international safety and regulatory standards (e.g., ISO, CE marking, FDA approval).
  7. Post-Market Surveillance (PMS) Plan – A detailed plan on how the manufacturer will monitor device safety and effectiveness post-market.

Importance of DMFs in UAE Medical Device Registration

  • Regulatory Compliance: DMFs ensure medical devices meet UAE’s stringent regulatory standards, facilitating quicker approvals.
  • Efficient Communication: A DMF standardizes communication with MOHAP, streamlining the regulatory review process.
  • Intellectual Property Protection: While providing detailed information, DMFs protect proprietary data by maintaining confidentiality of trade secrets.

Submission Process in UAE

Manufacturers must submit their DMF and regulatory documents through MOHAP’s online medical device registration portal. The process generally involves:

  1. Creating an account on MOHAP’s digital platform.
  2. Filling in the online application and uploading required documents.
  3. Review and evaluation by MOHAP.
  4. Approval and issuance of a medical device registration certificate.

The review timeline varies depending on device classification and complexity, with higher-risk devices requiring more detailed scrutiny and clinical data.

Conclusion

Preparing a Medical Device Master File for the UAE involves thorough compilation of technical and regulatory information. By understanding and adhering to MOHAP’s specific guidelines, manufacturers can efficiently navigate the regulatory landscape, ensuring market access while maintaining the highest standards of quality and safety.

A well-prepared DMF not only facilitates compliance but also supports the UAE’s commitment to ensuring the availability of safe and effective medical devices in the region.