Contact us
search
ENG
Deutsch
Français
Contact us
  • There are no suggestions because the search field is empty.
Service Area
United Arab Emirates Medical Device Regulations

Expert support for regulatory compliance in the UAE. Qserve helps medical device and IVD manufacturers meet local registration requirements.

Regulatory Compliance for Medical Devices in the UAE

UAE Medical Device Regulations

The United Arab Emirates (UAE) regulates medical devices through the Ministry of Health and Prevention (MOHAP) under the Drug Control Department (DCD). Medical device manufacturers must comply with specific regulatory requirements to enter the UAE market to ensure patient safety and product effectiveness.

Key Regulatory Requirements for Medical Devices in the UAE:

  1. Authorized Representative: Foreign manufacturers must appoint a licensed UAE-based company as their Authorized Representative or Marketing Authorization Holder (MAH) to act as the official regulatory liaison.Manufacturing
  2. Site Registration: First-time importers must register their manufacturing site with MOHAP before submitting device registration applications.
  3. Device Registration: All medical devices must be registered with MOHAP before being sold or distributed.
  4. ISO 13485 Certification: A valid ISO 13485:2016 certificate is required for the manufacturing site registration process.
  5. Documentation Requirements: Manufacturers must submit technical documentation, certifications, and details about the manufacturing site for evaluation.
  6. Import License: An import permit from MOHAP is required before medical devices can enter the UAE market.
  7. License Validity: Device registration licenses are valid for five years and must be renewed before expiration.
Get Support Now
Qserve Group 23
Services

Qserve services for UAE

Regulatory Strategy

A tailored plan to meet UAE regulatory requirements and ensure efficient market access.

Compliance Guidance

Clarity on what is required to align products, documentation, and processes with MOHAP regulations.

Medical Device Registration Support

Support with compiling and submitting medical device registrations to the UAE health authorities.

IVD Registration Support

Guidance on registering in vitro diagnostic devices in accordance with UAE regulatory standards.

Authorized Representative Services

Local representation through a licensed Marketing Authorization Holder (MAH) in the UAE.

Gap Analysis

Review of documentation and systems to identify and resolve compliance gaps.

Risk Management

Development or assessment of risk management files in line with ISO 14971 and local expectations.

Technical Documentation Preparation

Compilation and formatting of technical files according to UAE submission requirements.

Submission Package Preparation

Creation of complete, regulator-ready submission packages for UAE device approval.

Label Translation

Accurate Arabic translation of product labels to meet local language and layout standards.

Instructions for Use (IFU) Translation

Clear, compliant Arabic translations of user manuals and IFUs for device registration.

Ministry of Health and Prevention

Risk-based classification

The UAE follows the Global Harmonization Task Force (GHTF) classification system, categorizing devices by risk level:

Medical Devices:
Class I – Low risk
Class II – Low to moderate risk
Class III – Moderate to high-risk
Class IV – High risk

In Vitro Diagnostic Devices (IVDs):
Class A – Low risk
Class B – Low to moderate risk
Class C – Moderate to high-risk
Class D – High risk

The classification is based on intended use, duration of use, and degree of invasiveness of the device.

Get Support
Registration Routes for Medical Devices in the UAE

Medical Device Registration UAE

  1. The registration route depends on the device cassification:
    1. Listing Route (Low-Risk Devices)
      Applicable to Class I medical devices and devices used in hospitals under professional supervision.
    2. A simplified evaluation process is required.
    3. Upon approval, a Listing Certificate is issued.
    4. An import permit is required to market the device in the UAE.
  2. Registration Route (Higher-Risk Devices)
    1. Site Registration: Required if a manufacturing site imports to the UAE for the first time.
    2. Device Registration: Includes a comprehensive evaluation by a technical committee.
    3. Upon approval, a registration license is issued, allowing marketing and distribution.

Qserve’s regulatory experts assist manufacturers in preparing the required documentation and building a submission package for a smooth registration process. evaluation process.

Qserve Group 12
Quality & Clinical
Get in touch for more information about UAE Market Access
strategy
Regulatory Requirements in the UAE

Quality Management System (QMS)The UAE does not impose additional QMS requirements beyond ISO 13485 compliance.Clinical RequirementsNo specific clinical data requirements apply, but complete documentation must be submitted with the registration application.

🖋
Documents required for registration

Certificate from the Country-of-Origin Regulatory Authority (e.g., Free Sale Certificate, CE Mark, ISO 13485 certificate).Product Information (IFU, user manuals) in English and Arabic. Composition Certificate (if applicable) and MSDS for devices with medicinal/chemical components. Registration & Marketing Status in other countries.

Timelines and fees

Local Representative Requirement

Foreign manufacturers must appoint a UAE-based Authorized Representative (Marketing Authorization Holder) to submit registration applications and ensure compliance.

Qserve partners with a trusted local regulatory expert in the UAE to act as your license holder and manage all regulatory obligations, including:

- Registration submission
- Regulatory compliance
- Liaison with MOHAP

Regulatory Timelines and Fees

Regulatory Review Timeline: 45 working days.
Application Fee: 100 AED.
Device Registration Fee: 5,000 AED.

Important links and guidance documents

Federal Law No. 8 of 2019 - Arabic
This document lays out the regulatory framework for medical products (including medical devices), the profession of pharmacy, and pharmaceutical facilities in the UAE.


Cabinet Resolution No. (90) of 2021 (English) Provides the executive regulations for Federal Law No. 8 of 2019.

server render fail/waiting for island-7f870ei1R0 (separate island render, inside)