pharmacetical law

1. (ACZACILIQ TESQILI )
TEACHER:P.H.D :FARAH
THE STUDENT : AL-BUISSA MUHAMMED HAMED
GROUP :887B
3RD COURSE 2015-2016
THE LAW OF UAEON MEDICAL
PRODUCTS

2. Healthcare is among the priority sectors identified by the UAE government and as
a result, the UAE healthcare industry has displayed extraordinary growth and
significant progress in the past few years. In line with the UAE government’s focus
to improve the standard of healthcare, each year the UAE hosts the largest
healthcare event in the region – the Arab Health.The Arab Health provides the
perfect business platform for healthcare companies to showcase their products
and enter into tie-ups with regional institutes.This year’s Arab Health took place in
January and attracted over 3000 exhibitors from 60 countries and more than
65,000 healthcare professionals from across the world.
Given the tremendous success of the event, it is expected that many foreign
companies would be looking to enter into the UAE healthcare market either
through distributorships and agencies or by setting up a legal entity in the country.
However, prior to supplying any medical devices in the UAE, it is crucial that
foreign companies register their products with the relevant authorities.This article
briefly sets out the main features of the regulatory guidelines for medical devices
in the UAE and how it might affect medical device companies that are
contemplating business in the UAE.

3. Ministry of Health Guidelines
Medical devices are regulated by the Ministry of Health which has enacted
certain guidelines for the registration of medical products. The guidelines
are intended to prevent unsafe or ineffective medical devices from entering
the local market, while providing the public with timely access to medical
devices and preventing the entrance of unsafe devices in the market.
According to the guidelines, medical device manufacturers must register
their products before they can market their products in the UAE.
The Ministry of Health has worked to ensure the highest international
standards in developing the criteria for medical device registration.
Furthermore, the registration guidelines were designed to simulate
internationally recognized rules and regulations; mainly the EU Medical
Device Directive (93/42/EEC) and US Food and Drug Administration
Guidelines.
Registration of Medical Device
The guidelines set out the exhaustive requirements to register medical
devices. 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 guidelines broadly provide four classes of medical devices for
the purposes of registration. This 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.

4. Depending on the classification of the medical device in question,
and the information available with regard to approvals by regulatory
bodies in other countries, the Ministry of Health considers an
application for registration through either a one stage or a two stage
process.The application must also be supported by the submission
of objective evidence relating to the safety and effectiveness of the
medical device.The registration guidelines also list the information
that is necessary to be submitted in order to be considered for
registration. In addition to the application, several supporting
documents are required to be submitted including prior approval
from recognized regulatory agencies, such as those in Europe, the
US, Australia, Canada or Japan.
If the safety and effectiveness of the medical device is established
and the Ministry of Health approves the registration, a certificate of
registration is granted which permits the importation and sale of the
registered medical device in the UAE.The registration is generally
valid for 5 years.

5. Post-Market Obligations
As the key purpose of registering medical devices is to ensure safety, the
guidelines also provide for post-market obligations with regard to
monitoring, and preparing for, safety issues that may arise in the market
place. The post-market obligations include the obligation:
a) to maintain distribution records;
b) to maintain complaint handling procedures and records;
c) to maintain adverse incident reporting procedures and records; and
d) to have procedures in place that will allow to promptly and
effectively execute investigations and recalls of defective or potentially
defective medical devices.
Conclusion
The healthcare industry in the UAE is set to boom and many foreign players
would be interested to leverage opportunities offered by the UAE healthcare
industry. Whether a foreign company decides to supply through a distributor
or set up their own business, it can sometimes be difficult for foreign
entrants to meet regulatory requirements for medical devices. Diaz, Reus &
Targ LLP can assist you with all aspects of healthcare regulatory framework,
particularly in respect of advice relating to registration of medical
devices.

6. MEDICAL DEVICE REGISTRATION IN THE UAE
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.
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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. THANKS FOR WATCHING