Medical device registration in the UAE

Nick O'Connell
[email protected]

The healthcare industry in the UAE is set to boom. Dubai is in the process of setting itself up as a regional
hub for medical tourism, and there is a drive towards improving the standard of healthcare throughout the
country. This article briefly outlines the regulatory approval process for medical devices in the UAE.

General Background
The Ministry of Health has issued registration guidelines for medical devices. The Registration Guidelines
set out the requirements for an application for regulatory approval. The registration system is intended to
prevent unsafe or ineffective medical devices from entering the local market, while allowing patients
access to medical devices that may help them.

The Ministry has aimed for international standards in developing the criteria for medical device
registration. The Registration Guidelines themselves acknowledge that the various requirements for
registration largely simulate internationally recognized rules and regulations such as the EU Medical
Device Directive (93/42/EEC) and US Food and Drug Administration Guidelines. By way of example, the
Registration Guidelines define various terms using the definitions that closely resemble those provided in
the EU Medical Device Directive.

Application requirements
An application to register a medical device in the UAE must be made by the device manufacturer or its
local representative. The local representative must be formally authorized by the manufacturer to handle
the application process and the manufacturer’s legal obligations and responsibilities with regard to putting
the medical device on the market in the UAE.

The Registration Guidelines provide four classes of medical device for the purposes of registration. The
classification system takes into account aspects such as the period of time for which the medical device is
intended for use, and the degree of invasiveness on the body.

Depending on the classification of the medical device in question, and the information available with
regard to approvals by regulatory bodies elsewhere, the Ministry’s Committee on Medical Device
Registration will consider an application for registration through either a one stage or a two stage process.
Upon application, the Committee will review the medical device and decide whether or not it is able to
issue a certificate of registration on the basis of the material submitted with the application, or whether
further evidence relating to safety and effectiveness needs to be considered before a formal determination
can be made.

The application must be supported by the submission of objective evidence relating to the safety and
effectiveness of the medical device. As in other jurisdictions, the preparation and submission of such
advice is a significant undertaking. The Registration Guidelines list the information that it is necessary to
file in order to be considered for registration. As well as the formally executed official application form, and
depending on the classification of the device, the necessary documents can include:

● Authenticated copies of certificates relating to governmental approval of the device’s manufacturing

facility in the country of origin.
● Copies of all certificates, documentation and letters of regulatory approval/clearance to manufacture,
sell, import and export the medical device.
● Evidence of established procedures and systems for distribution records, complaint handling, adverse
incident reporting and recall.
● Product and production information, such as manufacturing process and facilities information, device
 description, specifications of materials used in manufacturing and packaging, intended use and
instructions for use, indications and contraindications, warnings and precautions, potential adverse
events, alternative therapy, device labeling, shelf-life stability, animal/human tissue content.
● Copies of certification and documentation certifying conformity to product standards, safety and
effectiveness requirements, and quality systems in design and manufacturing.
● Date of first introduction and use, list of countries where device is marketed and details of corresponding
regulatory status, and a summary of reported problems with the device since introduction.
● Risk assessment comprising of risk analysis, evaluation and reduction measures, and detailed
information on safety and effectiveness studies, including pre-clinical and clinical studies, process
validation studies, software validation studies where appropriate, and literature studies, with summary of
studies, conclusions drawn from those studies and bibliography of published reports dealing with the
device.
● Objective evidence on the biological safety of the device.
● Peer-reviewed scientific literature dealing with the device.
● Price information, including ex-factory price, wholesale price in the country of origin, and retail price in
the country of origin.

As well as the documents and information listed above, it is also necessary for the applicant to submit a
declaration confirming that the submitted material is true and that the applicant will be fully responsible
for the medical device and its post market plan, and that the applicant will comply with the requirements
of the Ministry’s Drug Control Department (the “DCD”) after the medical device has been placed on the
market.

As far as formalities are concerned, it should be noted that the Registration Guidelines are somewhat
prescriptive when it comes to the way in which the materials are prepared and submitted, and all
documents, including certificates should be in English or Arabic.

Registration
If the safety and effectiveness of the medical device is established and the Committee approves the
registration, a certificate of registration is granted, and the importation and sale of the registered medical
device is permitted. The registration is valid for 5 years, although if there are material changes to the
product data submitted in support of the application, then the certification may become invalid. The DCD
is also entitled to cancel the registration of a medical device if the registrant so requests, or if
circumstances warrant cancelling the registration. We anticipate circumstances warranting cancellation to
include, for example, where post-market obligations have not been met, where the product proves to be
unsafe or the quality of the product becomes lower than at the time of the application for regulatory
approval, where unapproved labeling is adopted, and where the medical device infringes a third party’s
intellectual property rights.

Post-market obligations
As the key purpose of registering medical devices is to ensure safety, the Registration Guidelines provide
for post-market obligations with regard to monitoring, and preparing for, safety issues that may arise in
the market place. As noted above, failure to comply with these obligations is a basis upon which the DCD
can cancel the registration of a medical device.

The post-market obligations include the obligation to maintain distribution records (to facilitate
traceability), to maintain complaint handling procedures and records, to maintain adverse incident
reporting procedures and records, and to have procedures in place that will allow the registrant to
promptly and effective execute investigations and recalls in respect of defective or potentially defective
medical devices.

If post market procedures have already been established by a registrant for one type of registered medical
device, it is not necessary to resubmit the post-market procedures for other medical device registration
applications, unless the procedures previously outlined have changed or need to be varied due to the
nature of the subsequent medical device. If procedures have been submitted in respect of a previous
application, it will be sufficient to refer the authorities to that material.

General
It can sometimes be difficult for foreign applicants to meet regulatory requirements for medical devices.
One example of the type of problem that might be encountered is where the subject medical device is not
something that would require regulatory approval in the country of origin, and thus not something for
which country of origin approval documentation can be provided.

Al Tamimi & Company is able to assist with all aspects of medical device regulatory approval, particularly
in respect of advocacy relating to the acceptance of supporting documentation. Although we hope it will
not be required, we are also able to assist with recalls and product liability issues.