Medical Devices Regulation for United Arab Emirates (UAE)

The UAE is like the KSA a member of the AHWP and the Medical Devices are regulated by the Ministry of Health (MOH) in the United Arab Emirates. UAE Medical Devices regulations are substantially orientated towards GHTF guidelines as well as towards EU requirements.

Classification requirements and the evaluation of Devices follow international regulations and guidelines, mainly those of:

• The IMDRF for Medical Devices,
• The US Food and Drug Administration’s Devices Regulation,
• The EU Medical Devices Directive 93/42/EEC,
• The EU in Vitro Diagnostic Devices Directive (IVDD) 98/79/EC and
• The EU Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC.

The similarity between the classification of medical Devices and the registration Guideline of the MOH is shown by the fact that certain definitions are very close to those provided by the EU Medical Devices Directive.

The guidelines provide for a simplified registration process for Devices that have received approval from recognized regulatory agencies, such as those in Europe, the US, Australia, Canada or Japan.

The Medical Devices manufacturers must be registered with the Ministry before they can market their products in the UAE. Companies who wish to export their products into the UAE must engage a local representative or distributor with a licensed medical store for registration of their products with the MOH.

In order to register Medical Devices in the UAE, the product as well as the company must be registered there. The appointed local representative or distributor must submit a medical devices and a manufacturer’s company registration application form to the Ministry’s Drug Control Department.

Required Documentation

1. Product Registration

In order to register for medical devices, the applicant is asked to submit the following documentation in Arabic or English to the MOH. The documentation varies depending on the device classification.

Table: UAE Medical Devices regulation: the required attachments per Devices Class

Documentation	Class I/ General IVD A	Class II/ Class B IVD	Class III/ Class C IVD	Class IV/ Class D IVD
Application Form	√	√	√	√
CE certificate and FSC (both legalized by the Chamber of Commerce and the UAE embassy)	√	√	√	√
Declaration of Conformity / Evidence of Conformity to the Essential Principles	√ Self- Declaration	√	√	√
Company registration certificate legalized by the chamber of commerce and the UAE embassy in the country of origin	√	√	√	√
Status of Device distribution	NA	√	√	√
Declaration of prices	√	√	√	√
essential principles checklist	√	√	√	√
Post-market requirements/ vigilance system and risk assessment	NA	√	√	√
Manufacturing process: Process Validation Studies Software validation studies (if applicable)	NA	NA	√	√
Safety and effectiveness data, risk assessment, pre-clinical and clinical studies	NA	NA	√	√
Labeling & samples Three copies (artwork) of each product packaging, labeling and promotional material Sample (if applicable). Labeling and packaging must have: the product name, name and address of the company printed in English and/or Arabic, manufacturing date and/or expiration date, Medical Devices for single use must be labeled accordingly on the outer pack	√	√	√	√
Shelf life study	NA	NA	√	√

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2. Company registration

In the UAE the company registration file should be submitted at the same time as the registration files of its products.

Companies’ registration requirements

• Application for the medical Devices company,
• Company business license,
• LoA,
• Organization of the quality assurance system (flow chart),
• Notarized copies of relevant certificates for Quality Accreditations from recognized notified bodies for each manufacturing facility involved in the manufacturing of the medical Devices intended for registration in the UAE,
• For classes III & IV / IVD C & D manufacturer: copies of the Design Examination, Type Examination certificates, or equivalent health authority approvals issued for these Devices should be provided as proof of compliance of the company with best practices,
• A recent audit report.
• The general profile has to include the following Information:

1. Company name, address, including the corporate structure as well as all company names of the company and its manufacturing sites used,
2. Contact name, telephone, fax numbers, and e-mail addresses,
3. Total number of employees (all shifts) covered by the scope of the audit,
4. Product range and class of Medical Devices being manufactured (the class of medical Devices may differ from one the regulatory authority of one UAE country to another),
5. Types of Medical Devices sold and/or planned to be sold in the UAE and/or GCC regions for which the regulatory requirements will be assessed, including a complete list of authorizations (e.g. licenses) issued for those Medical Devices (where applicable),
6. Location and function of each site,
7. A list of activities performed at each site,
8. Special manufacturing processes, e.g., software, sterilization, etc.

Furthermore, the technical documentation is required for submission, e.g. the following documents:

• Site Master File for each manufacturing site (if applicable),
• Warehousing information and general dispatch information as well as the implemented quality management system,
• Validation and verification processes for sterilized products and
• The general post-marketing surveillance plan.
• If the company has multiple manufacturing sites, each manufacturing location should be identified as follows indicating the manufacturing step carried out there (see application for company registration).: design, production, sterilization, packaging, labeling, and final release.

3. Country Specifics

After approval of the application, a registration number is given, which is valid for five years. A registration number can be revoked, if

• The applicant requests for it or
• Upon failure to meet the standards based on assessment or monitoring proving that
• The Devices are unsafe and/or harmful,
• The quality of the Devices is substandard,
• The Devices differ from the approved label.

Importation Rules

A pre-approval for the importation of the consignment is issued by the Drug Registration and Control Department for the importation of Medical Devices. This will be only allowed for importers with an MOH medical store license. Documents to be attached to the consignment pre-import approval application form are:

1. The legalized ISO 13485 by the UAE Embassy;
2. FSC / documentation or letters of regulatory approval / relevant CE certification/ clearance to manufacture, sale, import and export of the Medical Devices from the competent authority in the exporting country and the
3. Declaration of conformity.

The control of Medical Devices will be based on an implemented risk assessment and risk management.

Pre-Owned Medical Devices

Used Medical Devices are not allowed for importation into and marketing in the UAE.

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