Medical Device Registration

Guideline

Registration and Drug Control Department

Ministry of Health - UAE

2011

Acknowledgement
This guideline was prepared by a technical team under the supervision of:

Dr. Fatima Albariki - Director of Registration & Drug Control Department

The team members:

Dr. Ehab Youssef Abu Eida

Ph. Nadia Younis

Ph. Mohammed Abdullah

References used:
A- Global Harmonization Task Force (GHTF) for Medical Device,
B- EU Medical Device Directives 93/42/EEC, EU .in Vitro Diagnostic Device Directive
(IVDD) 98/79/EC and EU Active Implantable Medical Device Directive (AIMDD)
90/385/EEC.
C- US FDA (United State Food & Drug Administration)
D- Australia TGA
E- Singapore HSA

Introduction
The regulation of medical devices in UAE is aimed to maintain a balance between ensuring
product safety, quality and effectiveness and providing the public with timely access to
medical devices and preventing the entrance of unsafe or ineffective devices into the UAE
market. Accordingly, this guideline is constructed to provide safeguard measures for
patients, appliers, users and third parties against possible hazards they may be exposed
to as regards their health and safety during the use of such devices and their accessories.
The essential requirements in medical devices and their accessories and its implementation
were laid down by this guideline to assure that these devices shall meet the internationally
established principles and requirements relating to their design, classification,
manufacture, placing on the market, putting into service and inspection.
In this document we referred to the available guidelines issued by the World Health
Organization (WHO), US Food and Drug Administration (FDA), Global Harmonization Task
Force (GHTF), Health Canada, Asian Harmonization Working Party (AHWP), European
Council Directives 90/385/EEC and 93/42/EEC, Health Science Authority (HAS) of Singapore.
Medical Device control and regulation in UAE will be supervised and directed by Drug
Control Dept / MOH. Classification, requirements and evaluation of Medical Devices in UAE
is supported by the UAE Pharmacy Law No 4 for 1983 and will conform with the global
trends, rules and regulations recognized as above.
Finally we acknowledge the efforts of the technical team who prepared this guideline and
we are looking forward to achieve our goals toward public welfare by their implementation.

CONTENTS

P. No.

Definitions

Preface

11

Part One
General Rules

12

Importation Rules

15

Applicant and Local Representative Rule

16

Recognized Conformity Assessment Body

17

Medical Devices Marketing Approval Flow Chart

18

Classification Of Medical Devices

19

Conformity Assessment

21

Medical Device Manufacturer General Rules

22

The Company Registration Requirements

23

Medical Device Products registration/listing requirements

24

Annex 1 Classification rules

37

Annex 2 Classification Rules for In Vitro Diagnostic

41

Annex 3

45

Annex 4 Application for Medical Device Company

47

Annex 5

54

Annex 6

57

Annex 7 Essential Principles Conformity Checklist

76

Annex 8

87

DEFINITIONS
Accessory

An article which, whilst not being itself a medical device or having a

specific medical-device-intended purpose, is however intended by its
company and its manufacturing site to be used together with a parent
medical device to enable that medical device to achieve its intended
purpose.

Adverse Event

A problem that can, or actually resulted in permanent impairment,

injury or death to the patient or the user.

AIMD

Active Implantable Medical Device.

Authorized
Representative

Any person explicitly designated by a manufacturer, to represent it

within a country or jurisdiction where it is not itself established, in
respect of matters raised by the relevant Regulatory Authority, with
regard to the manufacturers obligations under the regulations that
operate within that country or jurisdiction.

Body orifice

Any natural opening on the body including the external surface of the
eye socket and any artificially formed permanent opening.

CE Marking on a
product:

indicates to governments that the product can be legally sold

within the European Union (EU) .
ensures the product can move freely throughout the European
Single Market,
indicates to customers that the product meets designated minimum
safety standards and therefore a minimum level of quality,
promotes public health and safety,
enhances product credibility,
leads to improved sales and greater customer satisfaction.

Conformity
Assessment

Systematic examination to determine the extent to which a medical

device fulfils specified requirements. Or/ Any activity relating to the
testing and examination and/or certification of the conformity of
devices and their accessories to the provisions of this Regulation.

Conformity
A body engaged in the performance of procedures for determining
Assessment Body whether the relevant requirements in technical regulations or
standards are fulfilled.
(CAB)
Custom-made
device

Any device made specifically in accordance with a duly qualified

practitioners written prescription which gives specific design
characteristics and is intended for the sole use of a particular patient
or client.

Device for
performance
evaluation

Any device intended by the company and its manufacturing site to be

subject to one or more performance evaluation studies in laboratories
for medical analyses or in other appropriate environments outside his
own premises.

EN

European Norms (Official European Standards)

5

Establishment

Means a legal person or company and its manufacturing site or importer

or distributor or authorized representative (excluding a retailer)
responsible for placing a medical device on the market.

EU

European Union

FDA

Food and Drug Administration

GHTF

Global Harmonization Task Force

GMP

Good Manufacturing Practice

Harm

physical injury or damage to the health of people, or damage to

property or the environment

Hazard

potential source of harm

Implantable
device

Any device, including those that are partially or wholly to be totally

introduced into the human body; or absorbed, which is intended:
- to replace an epithelial surface or the surface of the eye,
- by surgical intervention which is intended to remain in place after the
procedure.
Any device intended to be partially introduced into the human body
through surgical intervention and intended to remain in place after the
procedure for at least 30 days is also considered an implantable device.

Incident

An unusual (unexpected) event associated with the use of a medical

device. May or may not lead to problems. All incidents should be
investigated for potential problems.

Instructions for
use

Information provided by the Company and its manufacturing site to

inform the device user of the products proper use and of any
precautions to be taken.

Intended use or Objective intent of the company and its manufacturing site or other
intended purpose legal entity, or person, under whose name the device is placed on the
market, in respect of the application and performance of the device,
as indicated in the labeling and/or promotional material.
Invasive device

A device, which, in whole or in part, penetrates inside the body, either

through a body orifice or through the surface of the body. Body orifice
means any natural opening in the body, as well as the external surface
of the eyeball, or any permanent artificial opening, such as a stoma or
permanent tracheotomy. Surgically invasive device means an invasive
device which penetrates inside the body through the surface of the
body, with the aid or in the context of a surgical operation. Note:
Devices other than those referred to in the previous subparagraph and
which produce penetration other than through an established body
orifice, shall be treated as surgically invasive devices.

IVD

In-vitro Diagnostic Medical Device

Label

Information provided upon the medical device itself. Where physical

constraints prevent this happening, this term includes information
provided on the packaging of each unit or on the packaging of multiple
6

devices.

Labeling

Affixed to a medical device means written, printed or graphic matter;

accompanying a medical device or any of its containers or wrappers,
or, device, related to identification, technical description, and use of
the medical device, but excluding shipping documents.

Manufacturer
(Company) and
its manufacturing
site

Of a medical device is the person/organization that place a medical

device on the market under his/its own name and, thereby, is
responsible for ensuring that the device is suitable for its intended
purpose as indicated in the accompanying labeling. The function of the
company and its manufacturing site includes one or assignment of the
intended design; more of the following activities: sterilization or
labeling; assembly; production/fabrication; purpose; modification or
re-labeling or refurbishment of packaging; other processing; the
medical devices. When any of these responsibilities are subcontracted, the Company and its manufacturing site remains the
responsible party.
Note 1: Under its own name indicates the needs for the provision of
information on the medical device sufficient to allow a beneficiary,
user or Regulatory Authority to make contact with the Manufacturer, if
such proves necessary.
Note 2: Placing on the market is the initial action of making each
finished medical device available on the market, either for payment or
free of charge, with a view to its use for the purposes intended by the
Company and its manufacturing site as indicated in the labeling.

Medical device

any instrument, apparatus, implement, machine, appliance, implant,

in vitro reagent or calibrator, software, material or other similar or
related article:
a.) intended by the company and its manufacturing site to be used,
alone or in combination, for human beings for one or more of the
specific purpose(s) of:

diagnosis, prevention, monitoring, treatment or alleviation of

disease,

diagnosis, monitoring, treatment, alleviation of or compensation for

an injury,

investigation, replacement, modification, or support of the anatomy

or of a physiological process,

supporting or sustaining life,

control of conception,

disinfection of medical devices,

Indicate the sterilization process completion

7

providing information for medical or diagnostic purposes by means

of in vitro examination of specimens derived from the human body;
and
b.) which does not achieve its primary intended action in or on the
human body by pharmacological, immunological or metabolic means,
but which may be assisted in its intended function by such means.
Note 1: The definition of a device for in vitro examination includes, for
example, reagents, calibrators, sample collection and storage devices,
control materials, and related instruments or apparatus. The
information provided by such an in vitro diagnostic device may be for
diagnostic, monitoring or compatibility purposes. In some jurisdictions,
some in vitro diagnostic devices, including reagents and the like, may
be covered by separate regulations.
Note 2: Products which may be considered to be medical devices in
some jurisdictions but for which there is not yet a harmonized
approach, are:

aids for disabled/handicapped people,

devices for the treatment/diagnosis of diseases and injuries in

animals,

accessories for medical devices (see Note 3),

disinfection substances,

devices incorporating animal and human tissues which may meet the
requirements of the above definition but are subject to different
controls.

Note 3: Accessories intended specifically by manufacturers to be used

together with a parent medical device to enable that medical device
to achieve its intended purpose should be subject to the same
procedures as apply to the medical device itself. For example, an
accessory will be classified as though it is a medical device in its own
right. This may result in the accessory having a different classification
than the parent device.
Note 4: Components to medical devices are generally controlled
through the manufacturers quality management system and the
conformity assessment procedures for the device. In some
jurisdictions, components are included in the definition of a medical
device.

MOH

Ministry of Health

Notified Body

1. A Notified Body is an organization that has been nominated by a

member Government and Notified by the European Commission. A
Notified Body will be nominated based on designated requirements,
such as knowledge, experience, independence and resources to
conduct the conformity assessments.
2. The primary role of a Notified Body is to provide services for
conformity assessment on the conditions set out in the New
Approach Directives in support of CE Marking. This normally means
assessing the manufacturers conformity to the essential
requirements listed in each

PAL

Pharmaceutical Affairs Law of Japan

Place on the
market

First making available of a medical device with a view to its

distribution and/or use, other than where the use is restricted to premarket clinical investigation or performance evaluation of an in vitro
diagnostic device

Putting into
service'

Means the stage at which a device is ready for use on the Community
market for the first time for its intended purpose.

Regulatory
Authority (RA)

Government agency or other entity that exercises a legal right to

control the use or sale of medical devices within its jurisdiction, and
may take enforcement action to ensure that medical products
marketed within its jurisdiction comply with legal requirements

Risk

Combination of the probability of occurrence of harm and the severity

of that harm.

Risk analysis

systematic use of available information to identify hazards and to

estimate the risk

Risk assessment

overall process comprising a risk analysis and a risk evaluation

Risk control

process through which decisions are reached and protective measures

are implemented for reducing risks to, or maintaining risks within,
specified levels

Risk evaluation

judgment, on the basis of risk analysis, of whether a risk which is

acceptable has been achieved in a given context based on the current
values of society

Risk management systematic application of management policies, procedures and

practices to the tasks of analyzing, evaluating and controlling risk
Summary
Technical
Documentation
(STED)

Summary of technical documentation held or submitted for conformity

assessment purposes.

Technical
File/Technical
Documentation

Documentation required assessing conformity of the medical device

with the regulations.

Time (Duration)

Means the stage at which a device is ready for use on the Community
market for the first time for its intended purpose.
Transient
Normally intended for continuous use for less than 60 minutes
Short term
Normally intended for continuous use for not more than 30 days
Long term
Normally intended for continuous use for more than 30 days
Concept of continuous use
Concepts of duration such as transient short term and long term are
defined in terms of continuous use. Continuous must be understood as
an uninterrupted actual use for the intended purpose.

TGA

Therapeutic Goods Administration, Australia

Validation

Conformation, through the provision of objective evidence, that the

requirements for a specific intended use or application have been
fulfilled

Vendor

Any person who sells medical devices. This person could be a

manufacturer, an importer, a distributor, a wholesaler or a retailer.

Verification

Conformation, through the provision of objective evidence, that

specified requirements have been fulfilled

WHO

World Health Organization

10

PREFACE
The application to place a medical device on the UAE market must be made by the
device manufacturer or its authorized representative. The manufacturer or its
authorized representative is required to maintain objective evidence on the safety and
effectiveness of the medical device.
The objective evidence is used to assess the quality, safety and effectiveness of the
medical device for its intended use, to identify the risks involved when used for the
medical condition and to ensure that these risks are acceptable when weighed against
its benefits. T he application to place a medical device on the UAE market will result in
either Device listing or Device Registration based on approval of the relevant technical
committee.

11

Part One: General Rules

General Rules for Applications:

1.1
A.

Application processing route

Where a device is intended to administer a medicinal product, that device shall be
governed by this guideline, without prejudice to the corresponding regulations for
registration of medicinal products for human use set by the Drug Control Dept.
If, however, such a device is placed on the market in such a way that the device
and the medicinal product form a single integral product which is intended
exclusively for use in the given combination and which is not reusable, that single
product shall be governed by corresponding regulations for registration of medicinal
products for human use set by the Drug Control Dept. The relevant essential
requirements of Annex 7 shall apply as far as safety and performance related device
features are concerned.

B. Where a device incorporates, as an integral part, a substance which, if used

separately, may be considered to be a medicinal product and which is liable to act
upon the body with action ancillary to that of the device, the product will be
classified considering its main primary mode of action to achieve its intended
therapeutic effect. That device must be assessed and authorized in accordance with
this guideline. Primary mode of action is defined as the single mode of action of a
combination product that provides the most important therapeutic action of the
combination product. The most important therapeutic action is defined as the
mode of action that is expected to make the greatest contribution to the overall
intended therapeutic effects of the combination product.
C. All applications shall be made by submitting a dully filled in application form (Annex
4 for Company and Annex 6 for Product) accompanied with prescribed information
as detailed in these guidelines and given annexes. Evidence must be submitted to
the Drug Control to support the placement of the medical device on the UAE
market.
D. The company registration file should be submitted at the same time with the
registration files of its first product/s. Afterward files for the subsequent products
from the same manufacturer could be submitted without the need for the company
file. Medical devices for the same company that are under the same category or
family (carrying the same trade name) and which share one certification
documents could be consolidated within one application and registration file. For
12

products which come under listing rule, more than one category can be given at the
same time, given that categories are classified within the same line.
E. The applications will be processed both for expedite listing and will be issued a
listing certificate, or for the review of the Technical Committee which upon
approval will be granted a License certificate.
F. The registration files should include all required documents and studies for products
according to the presentation form and the class of the medical device product.
Annex 3 will list the following:

Types of medical devices subject for listing

Types of medical devices that will be exempted from this guideline and will
be regulated at the time of importation.

G. Product Registration Dossiers in addition to the non-refundable application fees and

the application form, need to include the List of Devices intended to be marketed
in UAE in Excel sheet format According to Annex 5 (soft copy and hard copy) with
labeling and artwork for each (soft copy). A representative label could be sufficient
for those groups of more than 5 versions based on an undertaking letter that the
labels will be identical for all those sections which are not related to the
differentiating factor (unit size, pack size, software version), given that, the parts
relevant to differentiation should be highlighted. Along with labels a representative
sample for each product category, should be provided with the company
registration dossier as well as the required certificates for each device. The Dossier
for medical devices (whether for listing or registration) will not differ in
requirements, as these requirements are based on the product class and labeling
and not on the route of registration it will follow. Companies can ask for exemption
from sample submission for those devices of big size, or extra expensive. In such a
case, the product catalogue and/or sample viewing could be considered by DR&CD.
H. Once an application has been accepted the processing of an application will involve
evaluation of application, request for additional data/samples and clarification of
some issues where applicable.

Once a query or a request has been raised, the

processing shall halt until after the response to the query has been received. If no
response to the query or request is received within six months from the written
query notification date, the application could be subject for cancelation or
rejection.

As part of evaluation of the medical device, a pre-registration GMP

inspection or Quality System audit may be conducted to verify compliance.

1.2
1.3

All applications and supporting documents shall be made in Arabic or English .

Declaration by the local authorized representative of the applicant should be
13

submitted for all applications to declare that:

a. He will insure that all submitted documents are accurate reflection of truth, by
ensuring that these were collected and compiled through the right and legal
channels, from the concerned responsible parties, that are authenticated by
signature and stamping of their source and by all possible means available.
b. He will be fully responsible for the product and post market plan submitted for
complain handling or recall.
c. Will fully comply with the requirements of the Drug control dept after the
placing the product in the market.

1.4

Registration/listing Certificate of the

When a device is found to have complied
applicant will be informed to that effect. A
issued. The approved artwork and design
certificates. (if applicable).

device
with all the registration requirements, the
certificate of registration or listing shall be
would be attached with the registration

1.5

Validity of registration/ Listing: The registration or listing of a medical device shall

be valid for five (5) years unless suspended or revoked by Registration and Drug Control
Department or terminated by the registrant.
The validity of registration shall be subject to:(a) Submission of biannual post-marketing surveillance reports for those products defined
by the DR&CD to be of high risk or require special attention.
(b) Submission of adverse effects reports associated with the use of device. (applicable for
pharmaceutical products classified as medical devices and class 3 and 4 invasive and
implantable medical devices).

1.6

Termination of registration
The Registration and Drug Control Department may by giving reasons in writing suspend or
revoke the registration of a device, or amend the conditions of its registration. The
registrant may by giving 30 days written notice and reasons to the Registration and Drug
Control Department terminate the registration of a device.

1.7

Appeals: Any objection to a decision of the Registration and Drug Control

Department in relation to any application for registration/Listing of a medical device could
be submitted in writing to Registration and Drug Control Department. If after
consideration of the representations, the department may approve registration/listing of a
medical device and if not satisfied it shall reject the application.

1.8

Application for variation of a registered device

The Registration and Drug Control Department should be informed on any significant
change(s) that could reasonably be expected to affect the safety or effectiveness of a
medical device. Significant change(s) may include any (but not limited to) of the following:
(a) The manufacturing process, facility or equipment;
(b) the manufacturing quality control procedures, including the methods, tests or
procedures used to control the quality, purity and sterility of the device or of the
materials used in its manufacture;
(c) the design of the device, including its performance characteristics, principles of
operation and specifications of materials, energy source, software or accessories; and
(d) the intended use of the device, including any new or extend use, any addition or
14

deletion of a contraindication for the device and any change to the period used to
establish its expiry date.
The above mentioned major changes will require Registration and Drug Control
Department approval before they can be implemented. In case the Manufacturer was
not sure of the urgency to report a certain change, the subject of change should be
communicated in writing to the DC&RD with a detailed report of expected risk and
impact. The Manufacture has to follow the decisions and instruction of DR&CD with
regard to the change.
Any other minor change(s) should be notified immediately to the Registration and Drug
Control Department and may be implemented without prior approval. All applications for
variation to a registered/listed device shall be made in writing and shall be accompanied
by the variation application fee.

1.9

Applications for renewal of registration

Applications for renewal of registration shall be made at least 90 days before the expiry
date of registration of the device. The application shall include submission of filled in
application form and information pertaining to changes that were made to a registered
device.

Importation Rules

2.1

All medical devices imports will not be cleared unless a pre-approval for
importation of the consignment is issued by Drug Registration and Control Department. This
is will be only allowed for importers with MOH medical store license.

2.2 Annex 3 lists all medical devices that are not subject for listing or registration as a
condition for pre-import application approval.
Documents to be attached to the consignment pre-import approval application form

1-ISO 13485 (or appropriate updated quality system in case this ISO standards are subject
to change; in case of any change/update the company should ensure that the substituting
certificate/document submission is endorsed by DR&CD) issued by recognized conformity
assessment Body for the Legal manufacturer and the source (the site where a significant
transformation of the medical device is carried out and where the medical device is
transformed into its first usable form).
2-Free sale Certificate / documentation or letters of regulatory approval / relevant CE
certification/ clearance to manufacture, sell, import and export the medical device from
competent authority in export country.
3-Declaration of conformity from legal manufacturer for class 1 devices.

2.3

Used medical devices are not allowed for importation and marketing into UAE. For
medical devices need to be exported from and then re-imported into UAE for
refurbishment/upgrading/maintenance purposes, the importer should ensure the
submission of documents which proofs that the subject medical devices were imported
into UAE through legal channels, then exported under approval of the DR&CD. Such
consignments will be cleared only upon a pre import permit signed by DR&CD and based
15

on proper documentation.

2.4 All devices should carry a clear labeling that includes the name of the company
responsible for the placement of the product in UAE market, Manufacturer at Country of
Origin , the local distributer address or website that mentions the local distributer name,
contact numbers and address. Local Distributors can add stickers on the outer pack of their
products in a way that doesnt conceal any basic or essential information. Any Medical
Device without distributer contact information will be liable for confiscation. The sticker
should be approved by DR&CD.
3

Applicant and Local Representative Rules

3.1 Where a company (Manufacturer) is based outside UAE, they have to appoint local
representative to act on behalf of them.
A local representative person is the legal entity licensed by ministry of Health, who has
received a mandate from the mother company (manufacture at Country of origin / company
that owns the rights of the device marketing worldwide) to act on its behalf with regard to
matters pertaining to placing the product in UAE Market and all its registration
requirements as set by DR&CD.
3.2 The local representative must be appointed in writing, by contract agreement; all
duties and responsibilities ought to be clearly defined and assigned. A legalized agreement
stating the appointment of the local authorized representative by the company should be
submitted.
The representative must file an evidence of a legalized Power of Attorney from the
company which authorizes him to delegate for his principals.
The local Representative may face liability claims resulting either from product malfunction
or serious complaint!
3.3

The local representative should be licensed by ministry of health as a medical store

or scientific office (in case of scientific office, importation and distribution activities
should be performed by an appointed Licensed Medical Store).

3.4 An application for registration of medical device(s) should be made & singed by the
Manufacturer in country of origin (MAH in case of pharmaceutical products) jointly with the
authorized and qualified local representative.
The applicant and its local authorized representative shall be responsible for the product,
information supplied in support of the application for registration and any variations
thereof.
3.5

The Local Representative Shall:

(a) Monitor the device on the market and inform the Authority immediately after the
detection of any problem relating to a registered device such as serious manufacturing
defects which may endanger public health.
(b) Facilitate communication between the applicant and the Authority on matters relating
to the product.
(c) Handle device recalls.
(d) Provide technical support and services to users of registered device(s).
16

(e) Required to notify Drug Control Department of any new models of medical devices they
market in UAE.
(f) Advise accurately on all the Regulatory issues of Labeling, including The Label itself,
Product Inserts, Inner and Outer Packaging, Instructions for Use and Advertising etc
(g) Can advice on effective implementation of all Regulatory Procedures, including
Adverse and Near Incident Reporting, Advisory Notice Issue (including Product Recall),
Post Market Feedback, Complaint Handling and Significant Change Notifications.
(h) The local representative should appoint a qualified person to act as a local contact
person responsible for the product, its registration or listing status updates, can
answer queries for all aspects regarding the device, its design and its use and can
effectively perform the above duties. The qualifications of this person should be
attached within the application along with documented proofs that supports his
training by the mother company on the device use and information.

3.6

Change of Local Authorized Representative

Principle Companies are free to make any changes desired or necessary for their
required Local Representative as far that they are compliant with the relevant UAE laws &
regul a t i o n . In such a case the Company is required to report all changes, including the
new local representative name, address or phone number, to Drug Control Department
within (30) business days supported by a documented clearance issued by relevant
authorities responsible for agency and trademarks regulation in UAE . The new rule allows
a foreign companys representative to report those kinds of changes directly to Drug
Control Department. However, foreign firms are advised to duplicate that reporting
effort to ensure compliance.

3.7

The Import of Medical Devices through Distributor that is licensed as a medical store
by ministry of health - Drug Registration and Control Department has to comply with a code
of practice issued by the Drug Control Department.
The main consideration is whether or not an existing distributor of manufacturers products
can act as the authorized representative, in this case distributor has to show evidence of
his ability to effectively fulfill the regulatory responsibilities mentioned in above section
alongside their marketing activities.

Recognized Conformity Assessment Body

The Registration and control Department in Ministry of Health may accept third party
conformity assessment procedures performed by recognized Conformity Assessment Body,
where they are registered and accredited by their respective Competent Authorities having
the capability of carrying out assessment of the medical devices. The Conformity
Assessment Body shall have technical qualification with the appropriate accreditation or
other official authorization and qualified personnel to conduct assessment of medical
devices within the scope accredited that shall include scientific technical evaluations of
high-risk medical devices and quality system assessments.

4.1

The Conformity Assessment Body shall fulfill the requirements of EN45000 series and
ISO/IEC 17025

4.2

UAE Ministry of Health Drug registration and Control Department shall accept
Accreditation of Conformity Assessment Bodies from European Union, Australia, Canada,
17

United State, Japan, and Singapore, that are equivalent to Notified Bodies associated with
CE marking.

4.3

LIST OF STANDARDS EMPLOYED IN THE ACCREDITATION OF CONFORMITY

ASSESSMENT BODIES:
1) TS EN ISO/IEC 17025- General Requirements for the Competence of Testing and
Calibration Laboratories
2) TS EN 45004- General Criteria for Operation of Various Types of Bodies Performing
Inspection
3) TS EN 45012- General Criteria for Certification Bodies Operating Quality System
Certification
4) TS EN 45011- General Criteria for Certification Bodies Operating Product Certification
5) TS EN 45013- General Criteria for Certification Bodies Operating Personnel Certification

18

Medical Devices Marketing Approval flow chart

Registration & Drug Control Department

Local Authorized representative (Scientific Office)

Distributor

Registration file for Medical Device Company +

registration file of Product(s) (category (line) wise )

Medical Store
Licensed

Declaration of Conformity of Essential requirements of M.D.

Submit Certificate for each device or device category

Labeling and artworks

Technical Documentation for pharmaceuticals, non listing devices

Registration committee
(Generally for pharmaceutical dosage form, for
products with exaggerated medical claims intended for
patients, new technologies, self testing kits)

Listing of the Devices

(Generally for products used in hospitals under
medical professional supervision, classical products
with no claims, blood bags, etc, in-vitro diagnostics
excluding self testing)

Assessment

Approval
Import permit

Post market Surveillance

19
Vigilance Reporting

Products exempted from

registration or listing

Classification Of Medical Devices

5.1 The control of medical devices will be based on a risk assessment and risk
management.
The level of regulatory control applied to the medical device is proportional to the degree
of perceived risk associated with the device. The requirements of the review process differ
for each class, type and technology of medical device.

5.2

Medical devices may be classified into 4 classes: Class l (low risk). II and III (medium
risk) or IV (high risk). Refer to annex 1 for classification rules of general medical devices.
Class I Devices those needing the lowest level of regulation because of low risk to the
patient except sterile products. They are subject to the General Controls requirements.
Declaration of conformity is accepted from the legal manufacturer.
Class II Devices are of a medium risk. These devices are invasive in their interaction with
the human body, but the methods of invasion are limited to natural body orifices. The
category may also include therapeutic devices used in diagnosis or in wound management
Class III Devices are of a medium risk. They are either partially or totally implantable within
the human body, and may modify the biological or chemical composition of body fluids.
Class IV devices are of high risk and require design/clinical trial reviews, product
certification and an assessed quality system involving clinical trials. These devices affect
the functioning of vital organs and/or life-support systems. Devices are usually invasive,
life-sustaining, life-supporting, or is used "in preventing impairment of human health or if
the device presents a potential unreasonable risk of illness or injury".

5.3 In-Vitro Diagnostic medical devices are based on the potential risk involved in their
use and interpretation clinically, refer to Annex 2 for their classification rules.
In-Vitro Diagnostic medical devices may be classified into 4 classes:
Class A (Low Individual Risk and Low Public Health Risk).
Class B (Moderate Individual Risk and/or Low Public Health Risk).
Class C (High Individual Risk and/or Moderate Public Health Risk).
Class D (High Individual Risk and High Public Health Risk).

5.4

General Consideration in classification

In terms of further interpretation of the decision rules, the following should be considered:
A. It is the intended and not the accidental use of the device that determines the class of
the device. If a medical practitioner uses the device in a manner not intended by the
20

company this does not change the class of the device for purpose of conformity
assessment.
B. It is the intended purpose assigned by the company to the device that determines the
class of the device and not the class assigned to other similar products.
C. as an alternative to classifying the system as a whole the determination of the class of a
particular device may be made with respect to the simplest configuration that can still
be considered , in view of its proper functional features, as a device in its own right . A
device that is part of a system may be classed as a device in its own right rather than
classifying the system as a whole. Similarly combination devices with parts that have
different functional purpose may be analyzed separately with respect to each of these
parts for instance a drainage device will have an invasive tube and non-invasive
collections device. These components may be classified separately.
D. Accessories must be classified separated from their parent device.
E. If a given device can be classified according to several rules, then the highest possible
class applies.
F. If the device is not intended to be used solely or principally in a specific part of the
body, it must be considered and classified on the basis of the most critical specified use.
Classification of the device will have to be determined on the basis of claims contained
in the information provided with the device. The company and its manufacturing site
must be sufficiently specific in that regard. If the company and its manufacturing site
wants to avoid the particular higher classification, then it must clearly on the labeling
the intended purpose in such a way that device falls into the lower class. The company
and its manufacturing site must provide as a minimum requirement either appropriate
positive or negative indications for use.
G. For a device to be "specifically intended" for the purpose referenced in a particular
classification rule, the company and its manufacturing site must clearly indicate that the
device is intended for such a specific purpose in the information accompanying the
device. Otherwise it is deemed to intended to be used principally for the purpose that is
accepted in general medical practice.
H. Multi-application equipment such as laser printers and identification cameras, which may
be used in combination with medical devices, are not medical devices unless their
company and its manufacturing site places them on the market with specific intended
purpose as medical devices.
I. Standalone software, e.g. software which is used for image enhancement is regards as
driving or influencing the use of a device and so falls automatically into the same class.
Other standalone software, which neither is nor regarded as driving or influencing the
use of a device is classified in its own right.

6 Conformity assessment
Medical devices company is required to conduct conformity assessment according to the
Essential Principles mentioned in this guidance. In certain cases (mostly determined by
the risk class of the device), the Technical Documentation may need to be reviewed/
and approval by a Conformity Assessment foreign Notified Body before the applicable
device is placed on the UAE market.

21

7 Medical Device Manufacturer general rules:

In order the company can place a medical device in UAE, should appoint a local authorized
representative who is responsible to apply for registration of the company prior or along
with its first product registration. For registration of manufacturers of Medical Devices
classified as non pharmaceutical dosage form, the file should include the required
documents and information relevant to the main manufacturer (final releaser / assembly)
to be evaluated according to the set regulation.
Declaration from manufacturer should declare the list of their manufacturing site, contract
manufacturer, and contract sterilizers, specification developers, re packagers or re
labelers, re processors of single-use devices, re-manufacturers, and manufacturers of
components or accessories that are sold or leased directly to the end user.
The Registration &Drug control Department has the right to ask for certificates for any of
the above sites
For the registration of manufacturers of Medical devices classified as pharmaceutical
dosage form, documentation and information relevant to all sites involved in manufacturing
process is required according to set regulation.

7.2

The Manufacturer (could be the products rights owner, or Marketing Authorization

Holder -MAH- in case of pharmaceutical products) at country of origin has to give the
technical support to the local authorized representative to submit application, to register
the manufacturing facilities where the products are manufactured. If marketing company
(products rights owner) is different than that of the manufacturer an authenticated
relationship issued from both parties (jointly or separately) should be submitted. The
technical agreements at this level are not needed (see below for product registration).

7.3

A company shall demonstrate compliance with ISO 13485 issued by recognized

conformity assessment body. The legalized (notarized as true copy if not original then
stamped from the UAE Embassy) copies for these accreditations should be attached to the
application as direction mentioned in Annex 4.

7.4 The company shall inform the Registration and Drug Control Department any major
changes of his quality management system and change of certification of his quality
management system e.g. change of the scope of certification or suspension or withdrawal
of certification by the conformity assessment body.
7.5

The Company must prepare provision for audit plan and provide all documents
necessary and related to contract manufactures / sterilizers that it employs.

7.6

Contract Sterilizers, Contract Device Manufacturers and Finished Device

Manufacturers are considered an extension of the finished device manufacturer's process.
The manufacturing site of the finished device is ultimately responsible for assuring that
validations, operations, process controls, quality assurance checks, etc. are appropriate,
22

adequately documented and correctly performed.

Contract sterilizers and contract manufacturers of finished devices are considered
manufacturers for the purpose of applying the accreditation.
Contract sterilizers and contract manufacturers of finished devices are subject to those
parts of the Quality System regulation that apply to the operations that are performed.
The finished device manufacturing site bears overall responsibility for the safety and
effectiveness of the finished device and must control all contractors.
For contract sterilization, the written agreement, between the company and contract
sterilizer, required may be referenced to determine how the parties have defined their
respective responsibilities.
For other contract manufacturers, any written agreements used as part of supplier controls
may be referenced to determine how the parties have defined their activities and
respective responsibilities.

The Company Registration Requirements

8.1

The company applying for registration shall make application in writing by

completing an official form Annex 4, which is to be signed by duly authorized

representative in the company and by the local authorized representative.

8.2

Company Business License includes their manufacturing site issued by the

competent authority in country of origin.

8.3

If the company has multiple manufacturing sites, each manufacturing location

should be identified indicating the manufacturing step carried out in as follows(see

application for company registration).:
A. Design
B. Production
C. Sterilization (if applicable)
D. Packaging
E. Labeling
F. Final Release.

8.4

Site Master File for each manufacturing site (if applicable- mainly required for

pharmaceutical product manufacturers).

8.5

Warehousing & dispatch General Information on Manufacturing Site and quality

management system follows.

8.6

Organization of Quality Assurance system (flow chart).

8.7

Notarized copies of certificates pertaining for Quality Accreditations from

recognized notified bodies (section above) for each manufacturing facility that involved in
the manufacturing of the medical device intended for registration in UAE.
23

8.8

For pharmaceutical products / class I (non-sterile) / IVD A manufacturer GMP

certificate (or equivalent) and manufacturing License (or equivalent after endorsing that
equivalent document by DR&CD) for each of the manufacturing sites is required.

8.9

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 a proof of compliance of the company with best practices.

8.10 Report of Recent audit by other auditing organization includes the nonconformities points and evidence of corrective action program and supporting
documentation (if applicable).
8.11

For Sterilization process: full verification that processes are appropriate to

produce sterile products should be submitted; including the controlled condition; evidence
that process records for each sterilization batch are maintained and traceable to each
batch; validation studies including qualification of sterilizer. Proofs that the process is
operating within specific limits; if the sterilization process is software controlled, the
validation of the software should be submitted; proves and SOPs that shows that the
equipment used has been adjusted, calibrated and maintained.

8.12

Post marketing surveillance general plan.

8.13

General profile including the following Information:

a) Company name, address, including the corporate structure as well as all company
names of the company and its manufacturing site used
b) contact name, telephone, fax numbers and e-mail addresses
c) total number of employees (all shifts) covered by the scope of the audit
d) product range and class of medical devices being manufactured (The class of a medical
device may differ from one regulatory authority to another)
e) 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)
f) Location and function of each site to be included.
g) a list of activities performed at each site
h) Any special manufacturing processes, e.g., software, sterilization, etc

Medical Device Products registration/listing requirements

9.1

Medical devices classified as pharmaceutical product:

i.e. has a definite pharmaceutical dosage form, the applicant for these products has to
submit the following requirements based on their classification as Sterile or non Sterile:
A. Filled application form.

24

B. Legalized approval issued by a health authority in Country of origin to market the

Product in the relevant country (Certificate of Pharmaceutical Product, or any
equivalent ).
C. All certificates/documents issued by an assessment bodies as an evidence of regular
approval or clearance of the medical device.
D. Manufacturing process (Master formula, manufacturing steps, sterilization method
used, and manufacturing facilities with steps performed at each). Flowchart for the
manufacturing process along with the relevant manufacturing sites should be
provided.
E. If the manufacturer(s) of any step different than the MAH/ legal manufacturer
/authorized representative in Country of origin, authenticated relationship letters
from the contract manufacturer along with the technical agreement copy needed.
The contract manufacturer should be registered and a separate file should be
submitted by the MAH for that purpose, site registration procedures will be followed
for each site separately.
F. Stability Study with shelf life specifications according to ICH guidelines for zone IV,
covering full shelf life, accelerated study for 6 months, in use stability studies (if
applicable).
G. Lab (QC) Analysis files, after QC file submission, at a later stage the applicant
should expect to receive a formal request issued by the Department QC lab section
for analysis requirements. These requirements should be submitted as a condition
for pricing and/or approval.
H. Efficacy & Safety clinical studies (upon request)
I.

Status of Device Distribution. (see appendix for explanation)

J. Arabic- English leaflet and labeling artwork that conforms to COO marketing
approval (the Department may ask for some changes, if this is the case the product
will not get the marketing approval unless the MAH in UAE submit the new artwork
with a sample from the first consignment that conforms to the approved Labeling
and packaging artwork. (see labeling requirements in the general guidelines
K. For products containing any animal/ human tissues or content, TSE and other
requirements may apply, (see appendix for explanation and Guidelines for Biologic
and Blood Derivative Products registration and import batch release).
L. Price certificate (only required for products subject to pricing, products used for
non therapeutic use and aesthetic purpose are exempted from pricing)

9.2

General Medical Devices (MD): Required Technical Documentation

The technical requirements to be submitted within the application file are based according
to the medical device class, table 2 in Annex 8 show the main classes for General Medical
Devices and IN-Vito Diagnostic classes and the required attachment for documents under
each type. In addition to the covering letter on the top, the requirements should be
25

attached within the application file in the same order of corresponding letters in the table
1 in annex 7 which is clarified in below per attachment:

Attachment A: Application Form

Attachment B: Regulatory Approval:

Medical device approvals or clearance from recognized regulatory authority can be
used to abridge the evaluation process for medical devices to be marketed in UAE.
Evidence of regular approval or clearance of the medical device in the form of
certification and relevant documents must be provided, as original authenticated
documents. For those devices not certified by any of below recognized countries,
will be examined and if appropriate may be exempted from recognized country
certification given that they are of class I only, for other classes the recognized
country or CE certification is a must

USA: US FDA clearance/approval: Certification for Foreign Government

The Certificate for Foreign Government is a written certification that a company or its
devices are in compliance with US law.
Canada: TPP clearance/approval
Japan: MHLW clearance /approval
Medical devices are regulated by the Pharmaceutical Affairs Law, which is enforced by the
Japanese Ministry of Health, Labour and Welfare (MHLW).
Europe (see table below):
Types of required certificates as in below mentioned table
EC Certification for quality System/GMP
The manufacturer must ensure application of a quality approved for the design,
manufacturer and final inspection of the products concerned.
For Class II & III : Full quality assurance / EC Type Examination Certificate
EC Type Examination is the procedure whereby a notified body ascertains that a
representative sample of the production covered fulfils the relevant provisions of the EU
Medical Device Directive. The certificate must contain the name and address of the
manufacturer, the conclusions of the inspection, the conditions of validity and the data
needed for identification of the type approved.
For Class IV: Full quality assurance / EC Design Examination Certificate, The
certification must contain the conclusions of the examination, the conditions of validity,
the data needed for identification of the approved design and, where appropriate, a
description of the intended purpose of the product.
Note: the notified body should be approved officially by health authorities in Europe, the
committee ask for document evidence regarding NB registration or licensing that details
Notified bodys qualification.

26

CLASS

ANNEX (according to EU
Directive)

TYPE of Certificate

Declaration of Conformity by
Manufacturer per Product
Family

Notified
Body

Product

Production

Notes
Fullfillment of Essential Requirements
can be demonstrated by a Full Quality
System

Class I

Annex VII

NA

Yes

NA

NA

NA

Class IIa

Annex II

Full Quality Assurance

system without Part 4

Yes

Yes

NA

Yes
Yes
(see Notes)

Class IIb

or Annex IV

EC verification

Yes (according to Annex VII)

Yes

Yes
(see
Notes)

or Annex V

Production Quality
Assurance

Yes (according to Annex VII)

Yes

NA

Yes

or Annex VI

Product Quality
Assurance

Yes (according to Annex VII)

Yes

Yes

NA

Annex II
or Annex III

Full Quality Assurance

system without Part 4
Type Examination

Yes
NA

Yes
Yes

NA
Yes

Yes
NA
Yes
(see Notes)
NA

+ Annex IV
or Annex III

+ EC Verification
Type Examination

Yes
NA

Yes
Yes

Yes
(see
Notes)
Yes

+ Annex V
or Annex III

+ Production Quality
Assurance
Type Examination

Yes
NA

Yes
Yes

NA
Yes

Yes
NA

+ Product Quality
Assurance

Yes

Yes

Yes

NA

Annex II

Full Quality Assurance

system

Yes

Yes

NA

Yes

and Annex II part 4 mandatory

or Annex III

Examination of the
design of the product
with NB certificate
Type Examination

NA
NA

Yes
Yes

Yes
Yes

NA
NA

+ Annex VI
Class III

27

EC Verification per product OR per

production. Not both, but either are
requested.

EC Verification per product OR per

production. Not both, but either are
requested.

+ Annex IV
or Annex III
+ Annex V

+ EC Verification
Type Examination

Yes
NA

Yes
Yes

Yes
(see
Notes)
Yes

+ Production Quality
Assurance

Yes

Yes

NA

28

Yes
(see Notes)
NA
Yes

EC Verification per product OR per

production. Not both, but either are
requested.

Attachment C: Post-market requirement

Medical Device Vigilance system

The purpose of a Medical Device Vigilance System is to minimize risk to the health and
safety of patients, users and others by reducing the like hood of a serious incident involving
a medical device being repeated. Close cooperation among the DCD, manufactures and
practicing medical professionals is necessary to achieve an effective vigilance system.

Manufacturers and local authorized representatives must also meet post-market

requirements that consist of:
Maintain Distribution Records

The manufacturers, local authorized representatives, importers and distributors are

required to keep distribution records to facilitate the accountability and traceability
of a medical device. This ensures that the device distribution channels in UAE,
including medical device exports from UAE, are identifiable.
Maintain Complaint Handling procedures and records
The manufacturers and local authorized representative are required to maintain
records of problem report relating to the safety of the device, including any consumer
complains and perform corrective action if necessary.
Maintain Adverse Incident reporting procedures and records
The manufacturers and local authorized representative are required to notify the DC&
RD of any adverse events related to a failure of the device or a deterioration of its
effectiveness, or any inadequacy in its labeling or in its directions for use, which has
resulted in the death or a serious deterioration in the state of health of a patient,
users or other person, or could potentially lead to such consequences due to its
recurrence.
Have Recall procedures in place
The manufacturers and local authorized representatives are to establish and
implement documents, procedures that will enable them to carry out effective and
timely investigations of reported problems and recalls; and maintaining records of
incident reports and of actions taken in response to these reports. Given that
defective or potentially defective medical devices should either be removed from the
market or measures are taken to correct the problem in an effective and timely
fashion.
The device company or its local authorized representative must submit the
documents for the following post-market procedures in applying to place the medical
device on the UAE market.
If a particular establishment has already submitted its post-market procedures in one
product application. it need not repeat this submission in subsequent applications
29

provided(a) proper reference are made to the documents submitted in the earlier
application and (b) there are no additional requirements and no changes made to the
procedures .

Attachment D: Status of device distribution

A summary of marketing history of the device is requested. The company and its
manufacturing site or its local authorized representative must provide a list of countries
where the device is currently being introduced and sold, its date of instruction and details
of the regulatory status (e.g. marketing approval, product recall, product ban, etc.). The
company and its manufacturing site or its local authorized representative must also provide
a summary of reported problems related to a failure of the device or a deterioration in its
effectiveness, or any inadequacy in its labeling or in its directions for use, and has led to
the death or serious deterioration in the state of health of a patient, user or other person,
or could do so were it to recur. These incidents require 'mandatory ' problem reporting that
the company and its manufacturing site had submitted to the relevant regulatory
authorities.
Attachment E: Product Information
E.1: Description and features of the Device:
This requires a description of the device, intended use and instructions of use. Product
information is manifested in the form of device labeling which must accompany each
device. This includes any physician's manual, pack labeling, and promoting material and
product brochure containing information on indications, contraindications, warnings,
potential adverse effects and alternative therapy.
E.2: Device Description
Besides a general description of the device, a more detailed description of the device
attributes is necessary to explain how the device functions, the basic scientific concepts
that form the foundation for the device, the component materials and accessories used in
its operation as well as packaging . A complete description of each functional component,
material or ingredient of the device should be provided, with labeled pictorial
representation of the device in the form of diagrams, photographs or drawing as,
appropriate.
E.3: Intended Use
This means the use for which the medical device is intended for which it is suited to the
data supplied by the company and its manufacturing site in the instruction as well as the
functional capability of the device.
E.4: Indications
This is a general description of the disease or condition that the device will diagnose, treat,
prevent cure, or mitigate includes a description of the target patient population for which
the device is intended.
E.5: Instruction of Use
These are all necessary information from the company and its manufacturing site including
the procedures, methods, frequency, duration, quantity and preparation to be followed for
safe use of the medical device. Instruction needed to use the device in a safe manner shall,
to the extent possible, be included on the device itself and/or on its packaging.
E.6: Contraindications
30

This is a general description of the disease or condition and the patient population for
which the device should not be used for the purpose of diagnose, treating, curing or
mitigating. Contraindications are conditions under which the device should not be used
because the risk of use clearly outweighs any possible benefit.
E.7: Warnings
This is the specific hazard alert information that a user needs know before using the
device.
E.8: Precautions
This alerts the user to exercise special care necessary for the safe and effective use of the
device. They may include actions to be taken to avoid effects on patients/users that may
not be potentially life-threatening or result in serious injury, but about which the user
should be aware. Precautions may also alert the user to adverse effects on the device of
the use or misuse and the care necessary to avoid such effects.
E.9: Potential Adverse Effects
These are potential undesirable and serious outcomes (death, injury, or serious adverse
events) to the patient/ user, or side effects from the use of the medical device, under
normal conditions.
E.10: Alternative Therapy
This is a description of any alternative practices or procedures for diagnosing, treating,
curing or mitigating the disease or condition for which the device is intended.
E.11: Physician's Manual
The physician's manual is also otherwise known as the user manual, operators manual,
prescriber's manual or reference manual. It contains directions under which the physician or
end-user can use a device safely and for its intended purpose. This should include
information on indications, contraindications, warnings, precautions, potential adverse
effects, alternative therapy and the conditions that should be managed during normal use
to maintain the safety and effectiveness of the device.
E.12: Specifications of materials used in device manufacturing and packaging
The material identifications and specifications must be provided including raw materials
and components. The information must include complete chemical, and their physical
properties to the extent necessary to demonstrate conformity with the relevant Essential
Principles. The information shall include complete chemical, biological and physical
characterization of the materials of the device.
Attachment F: Device Labeling
F.1: Device labeling
This is the description and information and literature that accompanies the device any time
while it is held for sale or shipped, such as any physician's manual, pack labeling,
promotional material and product brochures etc.
F.2: Pack Labeling
This is printed, written or graphic product information provided on or attached to one or
more levels of packaging, including the outer packaging or the outside container wrapper.
Any pack labeling which is not provided on the outer packaging must be easily legible
through this outer packaging.

31

F.3: Promotional Material

This is any mode or medium of disseminating product information for advertising and/or
labeling purpose (s) , for example all forms of printed (e.g. posters, tags, brochures,
pamphlets, circulars, booklets, instruction books, direction sheets, etc .) , written or
graphic product information and description, including those transmitted by means of print,
radio and television mass media .
Attachment G: Evidence of Conformity to Essential Principles
Provide evidence of conformity to Essential Principles of Safety and Performance by
completing the checklist appended as Annex 7
Note:
(i) Manufacturer should identify the essential principles of safety and performance that are
applicable to the device and the general methods used to demonstrate conformity to each
applicable Essential Principle. The methods that may be used include:(a) Compliance with a recognized or other standard(s)
(b) Internal industry methods
(c) Comparison to other similar marketed device
(ii) When the manufacturer uses national, international or other standards to demonstrate
conformity with the Essential Principles, full title of the standard, identifying numbers,
date of the standard and the organization that created the standard should be provided.

Attachment H: Safety and effectiveness data

H.1: Safety and Effectiveness Data

The safety and effectiveness requirements must be applied as a function of the risk
inherent with a given product. This enclosure requires a summary of all studies that the
company and its manufacturing site relies on to ensure that the device meets the safety
and effectiveness requirements, as well as the conclusions drawn from those studies. This
includes evaluation of those risks against the claimed benefits of the device and the
method used to reduce risk to acceptable levels. The studies must be organized into the
following sub-sections and reported as appropriate. An introductory summary should
accompany each study presented.
H.2: Risk Assessment
A list of possible hazard for these devices must be prepared. Indirect risks from medical
devices including lVD may result from device- associated hazards, such as instability, which
lead to erroneous results, or from user-related hazards, such as infectious reagents. The
evaluation of these risks against the claimed benefits of the device and the method used to
reduce risk to acceptable levels must be described. The individual or organization that
carries out the risk analysis must be clearly identified. The technique used to analyse risk
must be specified, to ensure that it is appropriate for the device and the risk involved.

H.3: Pre-clinical and clinical studies

Details must be provided on all biocompatibility tests conducted on the materials
used in a device. At a minimum, tests must be conducted on samples from the
finished, sterilized device. All materials that are significantly different must be
32

characterized. Information describing the tests, the results and the analyses of data
must be presented.
Complete pre-clinical physical test data must be provided, as appropriate. The
report must include the objectives, methodology, results and manufacturer's
conclusion of all physical studies of the device and its components. Physical testing
must be conducted to predict the adequacy of device response to physiological
stresses, undesirable conditions and forces, lone-term use and all known and possible
failure modes.
Pre-clinical animal studies used to support the probability of effectiveness in human
must be reported. These studies must be undertaken using good laboratory practices.
The objectives, methodology, results analysis and manufacture's conclusion must be
presented. The study conclusion should address the device's interactions with
animals fluids and tissues and the functional effectiveness of the device in the
experimental animal model(s). The rationale (and limitations) of selecting the
particular animal model should be discussed.
Clinical evidence of effectiveness may comprise device-related investigations
conducted in UAE or other countries. It may be derived from relevant publications in
peer-reviewed scientific literature .The documented evidence submitted should
include the objectives, methodology and results presented in context, clearly and
meaningfully. The conclusion on the outcome of the clinical studies should be
preceded by a discussion in context with the published literature.
H.4: Biocompatibility
details of all biocompatibility tests conducted on materials used in a device. At a
minimum, tests must be conducted on samples from the finished and sterilized device. All
materials that are significantly different must be characterized. Information describing the
tests, the results and the analysis of data must be presented.
H.5 Special requirements For Devices Containing Biological Material
Results of studies substances the adequacy of the measures taken with regards to the risks
associated with transmissible agents must be provided. This will include viral clearance
results for known hazards. Donor screening concerns must be fully addressed and methods
of harvesting must also be fully described. Process validation results are required to
substantiate that manufacturing procedures are in place to minimize biological risks.
H.6: Literature Studies
Copies are required of all literature that the company and its manufacturing site is using to
support safety and effectiveness. These will be a subset of the bibliography of references.
General bibliographic references should be device-specific as supplied in chronological
order. Care should be taken to ensure that the references are timely and relevant to the
current application.
Attachment I:Manufacturing Process
Provide details of manufacturing process for the device in the form of a list of resources
and activities that transform inputs into the desired output. The manufacturing process
should include the appropriate manufacturing methods and procedures, manufacturing
33

environment or conditions and the facilities and controls used for the manufacturing,
processing, packaging, labeling and storage of the device. A manufacturing process flow
chart should be submitted. Sufficient details must be provided to enable a person
generally familiar with quality systems to judge the appropriateness of the controls in
place. A brief summary of the sterilization method and processing should be included, if
any. If multiple facilities are involved in the manufacture of device, the physical address
and overview of activities for each facility should be provided.
I.1 Process Validation Studies
The results of all process validation studies must be presented. When the results of a
particular process cannot be verified by subsequent observation, that the process must be
validated to obtain objectives evidence. This applies to sterilization processes as well.
The procedures for monitoring and controlling the process parameters of validated process
must be fully described. For example, the type of process, details of the equipment and
process parameters employed in sterilization must be specified. Process validation data
must include sterility tests data and methods, culture media, time and temperature of
incubation, controls, number or samples examined and frequency of testing. Pyrogen test
data and methods are required , including frequency of testing , number of units tested
methods of testing , data from test results or a substantial rational for not conducting this
kind of testing . Toxicity test methods and data must be described. If the sterilizer is toxic
or produces toxic residues, test data and methods for establishing that post-process
sterilizer and/or are within acceptable limits must be presented.
I.2: Software validation studies, if applicable
The correctness of a software product is another critical product characteristic that cannot
be fully verified in a finished product. The company and its manufacturing site and/or
device sponsor must provide evidence that validates the software design development
process. This information should include the results of all verification, validation and
testing performed in-house and in a user's environment to final release, for all of the
different hardware configurations identified in the labeling. As well as representative data
generated from both testing environments.
Attachment J: Special requirements for Medical Devices manufactured from or
incorporating viable or non-viable animal tissue or their derivative(s).
J.1: General information supported by proof documents should be provided as
following:
1.
2.
3.
4.
5.
6.
7.
8.

Tissue type
Animal species
Certification of country of origin/ residence of animal
Name and address of the supplier of any animal material
Certificate of veterinary inspection
Certificate of abattoir Inspection
Certification that the animal was fit for human consumption
Risk assessment including:

Details of collecting, handling, storage and transport of materials.

Evidence of a system in place for animals and tissue traceability.
34

 Quality control processes and procedures in place to prevent contamination with

potential infectious/transmissible agents including TSEs and disinfection/decontamination
procedures in the event of contamination.
Details of processes used for inactivation or removal of infectious/transmissible agents*
and demonstration of the absence of infectious agents such as bacteria, fungi, yeast,
mycoplasma, viruses. This must include viral validation studies (in exceptional cases,
literature studies may be accepted solely, as proof of viral inactivation/removal, but a
justification and rationale must be provided by the manufacturer along with a copy of all
literature reports cited). Special consideration should be given to infectious
agents/transmissible agents known to infect the source animal.
Assessment of other applicable hazards such as those associated with the local host
response to the animal material including pyrogenic, immunological or toxicological
responses.
Validation studies for the removal/inactivation of TSEs are not currently required as they
are difficult to interpret. However, if claims are made concerning removal/inactivation of
TSEs the details of these studies must be provided.
J.2. special requirements according to source of the constituents of the product
Bovine Sourced
All materials in a device which are derived from a bovine source must be identified.
Examples are: bovine pericardium in heart valves, bovine viscera in gut sutures, bovine
bone in dental implants, and bovine collagen in lacrimal plugs. These also include devices
which are exposed to materials of bovine origin during manufacture (e.g. human or animal
cells grown in media containing fetal calf serum, tissue culture cells exposed to bovine
trypsin).
The risk of potential infectivity of BSE is being addressed primarily by selective sourcing.
All bovine material must be sourced from a country considered by UAE to be BSE free.
Ovine and Caprine Sourced
Devices derived from ovine (sheep) or caprine (goat) materials must, at this time, be
designated BSE free countries as sheep and goats have been shown to be experimentally
infected with BSE. In addition, this material must be sourced from a country that is free of
scrapie.
Other species
If tissues or derivatives from other ruminant species are used in the manufacture of
medical devices, any potential risks should be addressed in the risk assessment.
Documentation must be provided that feed that is or contains protein that originated from
a mammal other than a porcine or an equine (excluding milk, blood, gelatin, rendered
animal fat or their products) is not fed to ruminants.
Porcine Sourced
Drug Control department should be aware about the used material due to prohibited used
of procaine derivative because of Sharia Islamic law
Where porcine sources are used in the production of medical devices, the products must
be validated for the removal or inactivation of any potential zoonotic infectious agents
35

that have been identified in pigs, including those that are known to infect human cells in
vivo or in vitro, by inactivation/removal studies or through other valid scientific evidence,
including scientific literature reports to support specific processing.
Expressed from Cells
For medical devices derived from or containing material expressed from animal cells,
information must be provided which verifies that the Cell Line has been fully characterized
and tested for the absence of undesirable viruses which may be infectious and/or
pathogenic for humans.
It is recognized that some cell lines, especially those from rodents, used for the
manufacture of products will contain endogenous retroviruses, retrovirus particles or
retrovirus-like particles. In this case, the capacity of the manufacturing process to remove
and/or inactivate these retroviruses from the product should be demonstrated. The
virucidal capabilities of the processing steps must be validated. This would include
extensive screening for both endogenous and nonendogenous viral contamination which
should be performed on the master cell bank. Each working cell bank as a starting cell
substrate for therapeutic product production must be tested for adventitious virus using
either direct testing or analysis of cells at the limit of in vitro cell age, initiated from the
working cell bank.
A complete characterization of the expressed material(s) and carrier should be provided
including such information as:
1. full physical/chemical/biochemical characterization of the peptides/proteins using
analysis including mapping of the expressed peptide/protein and/or the carrier if
applicable, SDS-PAGE, cation exchange chromatography, 2D-gel electrophoresis and
HPLC;
2. device activity bioassays in vivo and in vitro;
3. studies of the pharmacokinetics, biodistribution and systemic effects of the
expressed agent; and;
4. Complete sterilization and stability information.

Annex 1
36

Classification rules
NON-INVASIVE DEVICES

1. All non-invasive devices are in Class I, unless Rule II, III or IV applies
2. All non-invasive devices intended for channeling or storing blood, body liquids or tissues,
liquids or gases for the purpose of eventual infusion, administration or introduction into the
body are in Class I, unless they may be connected to an active medical device in Class II or a
higher class, in which case they are Class II;
unless they are intended for use of storing or channeling blood or other body liquids
or for storing organs, parts of organs or body tissues, in which case they are Class II
3. All non-invasive devices intended for modifying the biological or chemical
composition of blood, other body liquids or other liquids intended for infusion into
the body are in Class III,
unless the treatment consists of
heat, in which case they are in Class II.

filtration, centrifuging or exchanges of gas or of

4. All non-invasive devices which come into contact with injured skin:
- are in Class I if they are intended to be used as a mechanical barrier, for compression or for
absorption of exudates;
unless intended to be used principally with wounds which have breached the dermis and can
only heal by secondary intent, in which case they are in Class III.
- are in Class II in all other cases, including devices principally intended to manage the
microenvironment of a wound.
INVASIVE DEVICES

5. All invasive devices with respect to body orifices

(Other than those which are surgically invasive) and which: a) are not intended for
connection to an active Such devices are invasive in body orifices and are not surgically
invasive. Devices tend to be diagnostic and therapeutic instruments used in ENT,
ophthalmology, dentistry, proctology, urology and gynecology.
Classification depends on the time of invasion and the sensitivity (or vulnerability) of
the orifice to such invasion. medical device or b) are intended for connection to a Class I
medical device
- are in Class I if they are intended for transient use;
- are in Class II if they are intended for short-term use
unless they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear
drum or in a nasal cavity, in which case they are in Class I,
- are in Class III if they are intended for long-term use;
unless they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear37

drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane, in
which case they are in Class II.
All invasive devices with respect to body orifices (other than those which are surgically
invasive) that are intended to be connected to an active medical device in Class II or a higher
class, are in Class II.
6. All surgically invasive devices intended for transient use are in Class II,
unless they are reusable surgical instruments, in which case they are in Class I;
unless intended to supply energy in the form of ionizing radiation, in which case they are in
Class III;
unless intended to have a biological effect or be wholly or mainly absorbed, in which case
they are in Class III;
unless intended to administer medicines by means of a delivery system, if this is done in a
manner that is potentially hazardous taking account of the mode of application, in which
they are in Class III.
unless intended specifically to diagnose, monitor or correct a defect of the heart or of the
central circulatory system through direct contact with these parts of the body, in which case
they are in Class IV.
7. All surgically invasive devices intended for short-term use are in Class II,
unless they are intended to administer medicines, in which case they are in Class III;
unless they are intended to undergo chemical change in the body (except if the devices are
placed in the teeth), in which case they are in Class III;
unless they are intended to supply energy in the form or ionizing radiation, in which case
they are in Class III;
unless they are intended to have a biological effect or to be wholly or mainly absorbed, in
which case they are in Class IV;
unless they are intended specifically for use in direct contact with the central nervous
system, in which case they are in Class IV;
unless they are intended specifically to diagnose, monitor or correct a defect of the heart or
of the central circulatory system through direct contact with these parts of the body, in
which case they are in Class IV.
8. All implantable devices, and long-term surgically invasive devices, are in Class III,
unless they are intended to be placed into the teeth, in which case they are in Class II;
unless they are intended to be used in direct contact with the heart, the central circulatory
system or the central nervous system, in which case they are in Class IV;
unless they are intended to be life supporting or life sustaining, in which case they are in
Class IV;
unless they are intended to be active implantable medical devices, in which case they are
38

Class IV;
unless they are intended to have a biological effect or to be wholly or mainly absorbed, in
which case they are in Class IV;
unless they are intended to administer medicines, in which case they are in Class IV;
unless they are intended to undergo chemical change in the body (except if the devices are
placed in the teeth), in which case they are in Class IV.
unless they are breast implants, in which case they are in Class IV.
ACTIVE DEVICES
9. All active therapeutically devices intended to administer or exchange energy are in Class
II,
unless their characteristics are such that they may administer or exchange energy to or from
the human body in a potentially hazardous way, including ionizing radiation, taking account
of the nature, the density and site of application of the energy, in which case they are in
Class III
All active devices intended to control or monitor the performance of active therapeutically
devices in Class III, or intended directly to influence the performance of such devices, are in
Class III.
10. Active devices intended for diagnosis are in Class II:
- if they are intended to supply energy which will be absorbed by the human body (except for
devices used solely to illuminate the patient's body, with light in the visible or near infra-red
spectrum, in which case they are Class I), or
- if they are intended to image in vivo distribution of radiopharmaceuticals, or
- if they are intended to allow direct diagnosis or monitoring of vital physiological processes,
unless they are specifically intended for:
a) monitoring of vital physiological parameters, where the nature of variations is such that it
could result in immediate danger to the patient, for instance variations in cardiac
performance, respiration, activity of central nervous system, or
b) diagnosing in clinical situations where the patient is in immediate danger,
in which case they are in Class III.
Active devices intended to emit ionizing radiation and intended for diagnostic and/or
interventional radiology, including devices which control or monitor such devices, or those
which directly influence their performance, are in Class III.
11. All active devices intended to administer and/or remove medicines, body liquids or other
substances to or from the body are in Class II,
unless this is done in a manner that is potentially hazardous, taking account of the nature of
the substances involved, of the part of the body concerned and of the mode of application, in
which case they are in Class III.

39

12. All other active devices are in Class I.

ADDITIONAL RULES
13. All devices incorporating, as an integral part, a substance which, if used separately, can
be considered to be a medicinal product, and which is liable to act on the human body with
action ancillary to that of the devices, are in Class IV.
14. All devices manufactured from or incorporating animal or human cells/tissues/derivatives
thereof,
whether viable or non-viable,
are Class IV,
unless such devices are manufactured from
derivatives that come in contact with intact
unless such devices are manufactured from
derivatives that come in contact with intact

or incorporate non-viable animal

skin only, where they are in Class
or incorporate non-viable animal
skin only, where they are in Class

tissues or their
I.
tissues or their
I.

15. All devices intended specifically to be used for disinfecting or sterilizing medical devices
are in Class II,
unless they are intended specifically to be used for disinfecting, cleaning, rinsing or, when
appropriate, hydrating contact lenses, in which case they are in Class III.
16. All devices used for contraception or the prevention of the transmission of sexually
transmitted diseases are in Class III,
unless they are implantable or long-term invasive devices, in which case they are in Class IV.

40

Annex 2
Classification Rules for In Vitro Diagnostic
Rule 1 - IVD medical devices intended for the following purposes are
classified as Class D:
Devices intended to be used to detect the presence of, or exposure to, a transmissible
agent in blood, blood components, blood derivatives, cells, tissues or organs in order to
assess their suitability for transfusion or transplantation, or
Devices intended to be used to detect the presence of, or exposure to, a transmissible
agent that causes a life-threatening, often incurable, disease with a high risk of
propagation
Rationale:

The application of this rule as defined above should be in accordance with the rationale
that follows: Devices in this Class are intended to be used to ensure the safety of blood
and blood components for transfusion and/or cells, tissues and organs for transplantation.
In most cases, the result of the test is the major determinant as to whether the
donation/product will be used. Serious diseases are those that result in death or longterm disability, that are often incurable or require major therapeutic interventions and
where an accurate diagnosis is vital to mitigate the public health impact of the condition.
Examples:

Tests to detect infection by HIV, HCV, HBV, HTLV. This Rule applies to first-line essays,
confirmatory essays and supplemental essays.

Rule 2 - IVD medical devices intended to be used for blood grouping, or

tissue typing to ensure the immunological compatibility of blood, blood
components, cells, tissue or organs that are intended for transfusion or
transplantation, are classified as Class C, except for ABO system [A (ABO1),
B (ABO2), AB (ABO3)], rhesus system [RH1 (D), RH2 (C), RH3 (E), RH4 (c),
RH5 (e)], Kell system [Kel1 (K)], Kidd system [JK1 (Jka), JK2 (Jkb)] and
Duffy system [FY1 (Fya), FY2 (Fyb)] determinations which are classified as
Class D.
Rationale:
The application of this rule as defined above should be in accordance with the rationale
for this rule which is as follows: A high individual risk, where an erroneous result would
put the patient in an imminent life-threatening situation places the device into Class D.
The rule divides blood grouping devices into two subsets, Class C or D, depending on the
nature of the blood group antigen the IVD medical device is designed to detect, and its
importance in a transfusion setting.

41

Examples:
1.) HLA, Duffy system (other Duffy systems except those listed in the rule as Class D are in
Class C).

Rule 3 - IVD medical devices are classified as Class C if they are intended
for use:
In detecting the presence of, or exposure to, a sexually transmitted agent. Examples:
Sexually transmitted diseases, such as Chlamydia trachomatis, Neisseria gonorrhoeae.
In detecting the presence in cerebrospinal fluid or blood of an infectious agent with a
risk of limited propagation. Examples: Neisseria meningitidis or Cryptococcus
neoformans.
In detecting the presence of an infectious agent where there is a significant risk that an
erroneous result would cause death or severe disability to the individual or fetus being
tested. Examples: diagnostic assay for CMV, Chlamydia pneumoniae, Methycillin
Resistant Staphylococcus aureus.
In pre-natal screening of women in order to determine their immune status towards
transmissible agents. Examples: Immune status tests for Rubella or Toxoplasmosis.
In determining infective disease status or immune status, and where there is a risk that
an erroneous result will lead to a patient management decision resulting in an imminent
life-threatening situation for the patient. Examples: Enteroviruses, CMV and HSV in
transplant patients.
In screening for selection of patients for selective therapy and management, or for or
for disease staging, or in the diagnosis of cancer. Example: personalized medicine.
NOTE: those IVD medical devices where the therapy decision would usually be made
only after further investigation and those used for monitoring would fall into class B
under rule 6.
In human genetic testing. Examples: Huntingtons Disease, Cystic Fibrosis.
To monitor levels of medicines, substances or biological components, when there is a
risk that an erroneous result will lead to a patient management decision resulting in an
immediate life-threatening situation for the patient. Examples: Cardiac markers,
Cyclosporin, Prothrombin time testing.
In the management of patients suffering from a life-threatening infectious disease.
Examples: HCV viral load, HIV Viral Load and HIV and HCV geno- and subtyping.
In screening for congenital disorders in the fetus. Examples: Spina Bifida or Down
Syndrome.
Rationale:

The application of this rule as defined above should be in accordance with the rationale
for this rule which is as follows: Devices in this Class present a moderate public health
risk, or a high individual risk, where an erroneous result would put the patient in an
imminent life-threatening situation, or would have a major negative impact on outcome.
42

The devices provide the critical, or sole, determinant for the correct diagnosis. They may
also present a high individual risk because of the stress and anxiety resulting from the
information and the nature of the possible follow-up measures.

Rule 4 - IVD medical devices intended for self-testing are classified as Class
C, except those devices from which the result is not determining a
medically critical status, or is preliminary and requires follow-up with the
appropriate laboratory test in which case they are Class B.
IVD medical devices intended for blood gases and blood glucose determinations for
near-patient testing would be Class C. Other IVD medical devices that are intended
for near-patient should be classified in their own right using the classification
rules.
Rationale:
The application of this rule as defined above should be in accordance with the rationale
for this rule which is as follows: In general, these devices are used by individuals with no
technical expertise and thus the labeling and instructions for use are critical to the proper
outcome of the test.

Example for self-testing class C:

Blood glucose monitoring,

Example for self-testing class B:

Pregnancy self test, Fertility testing, Urine test-strips.

Rule 5 - The following IVD medical devices are classified as Class A:

Reagents or other articles which possess specific characteristics, intended by the
manufacturer to make them suitable for in vitro diagnostic procedures related to a
specific examination.
Instruments intended by the manufacturer specifically to be used for in vitro diagnostic
procedures
Specimen receptacles
Note: Any product for general laboratory use not manufactured, sold or represented for
use in specified in vitro diagnostic applications are not deemed to be IVD medical devices,
as defined in this document. However, in certain jurisdictions products for general
laboratory use are considered to be IVD medical devices.

Rationale:
The application of this rule as defined above should be in accordance with the rationale
for this rule which is as follows: These devices present a low individual risk and no or
minimal public health risk.
43

Examples:
Selective/differential microbiological media (excluding the dehydrated powders which are
considered not to be a finished IVD medical device), identification kits for cultured
microorganisms, wash solutions, instruments and plain urine cup.
Note 1: In certain jurisdictions there may be differences as to whether a device
classified in this rule is considered an IVD medical device.
Note 2: The performance of software or an instrument that is specifically required to
perform a particular test will be assessed at the same time as the test kit.
Note 3: The interdependence of the instrument and the test methodology prevents the
instrument from being assessed separately, even though the instrument itself is still
classified as Class A.

Rule 6 - IVD medical devices not covered in Rules 1 through 5 are classified as
Class B.
Rationale:
The application of this rule as defined above should be in accordance with the rationale
for this rule which is as follows: These devices present a moderate individual risk as they
are not likely to lead to an erroneous result that would cause death or severe disability,
have a major negative impact on patient outcome or put the individual in immediate
danger. The devices give results that are usually one of several determinants. If the test
result is the sole determinant however other information is available, such as presenting
signs and symptoms or other clinical information which may guide a physician, such that
classification into Class B may be justified. Other appropriate controls may also be in
place to validate the results. This Class also includes those devices that present a low
public health risk because they detect infectious agents that are not easily propagated in
a population.

Examples:
Blood gases, H. pylori and physiological markers such as hormones, vitamins, enzymes,
metabolic markers, specific IgE assays and celiac disease markers.

Rule 7 - IVD medical devices that are controls without a quantitative or

qualitative assigned value will be classified as Class B.
Rationale:
For such controls, the qualitative or quantitative value is assigned by the user and not the
manufacturer.

44

CLASS

RISK LEVEL

EXAMPLES

Low Individual Risk and Low

Public Health Risk

Clinical Chemistry Analyzer ,

prepared selective culture media

Moderate Individual Risk

and/or Low Public Health
Risk

Vitamin B12, Pregnancy self testing,

Anti-Nuclear Antibody, Urine test
strips

High Individual Risk and/or

Moderate Public Health Risk

Blood glucose self testing, HLA

typing,
PSA screening, Rubella

High Individual Risk and

High Public Health Risk

HIV Blood donor screening, HIV Blood

diagnostic

Annex 3
Medical Devices Subject for listing:

Must not be of pharmaceutical dosage form.

All Class 1, medical devices.
Dressings and blasters intended to be in contact with wounds
Classical (not new technology) Invasive, transient or implantable Medical devices used
by Medical professional or within hospital use , given that dont carry labels intended
for patients or retail sale.(these include, syringes, sutures, pace makers, stents, dental
impressionsetc).
Blood collecting tubes and bags.
All should have no labeling directed for patients with exaggerated medical claims.
Class C & D IVD for laboratory use

Medical devices that may be granted importation pre approval without

listing or registration.

45

Printing graphing Papers.

Accessories for listed or registered medical devices.

Medical Device instruments Operating solvents or liquids that dont contact patients.

Woven and non woven clothing materials and their products(Gowns, masks, support
bandages, clothes,mattresses)

Hospital Furniture (soft and Hard): Beds, drawers, surgery platforms, mattresses,
trolleys, infusion stands, sheets, pillows, examining tables and chairs..etc).

In vitro diagnostic Reagents given that it is not self testing or from high risk A or B
categories.

Optical lenses given that not a contact lenses or contact lenses disinfecting solutions.

External Prosthesis (artificial extension that replaces a missing body part) not
intended for implantation.

The following Disposables and their equivalent: not intended for treating disease and
in not direct contact with wounds: (masks with no claims, medical trash bins,
examination gloves (non sterile), diapers, disposable bed sheets..etc).

Casts, plastic casts, collars, or any external devices to support the movement or
stabilizing of joints or the body parts including wheel chairs and clutches.

Materials and accessories used in manufacturing dental parts, dentures, dental braces
given that they are not intended for implantation within oral cavity and jaws. and
accessories with no risk for professional use.

IVD : Class A &B (given to be not self testing)

Non medical massage machines and chairs excluding those for eyes, or magnetic.

Filter papers.

Lab instruments that dont contact patients directly, examples: Microscopes, analysis
instruments, incubators, empty glass wares and plastic containers not for collecting
biological samples.

46

Annex 4
Application for Medical Device Company
1. Detail of Medical Device Company
Company Name:

City:

Country of origin:

Street:

Web site:(if available)

Post Code:

Contact Name:

Email:

Telephone:

Fax:

Business registration number in country of origin:

Validity:

Name of the competent authority that issued the business License :

Contact person:

Telephone:

Fax:
Email:
Please Indicate the nature of the Applicant? (click the appropriate boxes)
Manufacturer

Marketing Authorization Holder in Country of origin

(for pharmaceutical products)

Authorized Product rights owner in Country of origin

Others, Please specify _____________

Please tick the type of products manufactured by your company

47

 Active Implantable Medical Devices

In-Vitro Diagnostic Medical Device

Non Invasive Medical Devices

Electro Mechanical Devices

Invasive Medical Devices

Single Use Device

Non Active Implantable Devices

Ophthalmic and Optical devices

Dental Devices

Tissues of Animal Origin

Lab Reagent

Accessories

Others , Please specify____________

2. Manufacturing Facility
Please complete the following information about each facility / location included in this assessment.
Main Manufacturing sites
City:

Country:

Address:

Post Code:
Tel:

Fax:

Email:
No. of employees (for Medical devices) at the manufacturing site

Brief description of the facility and principal activities occurring at this site:
(Further details may be attached on a separate sheet, In case of Pharmaceutical Dosage Form please specify the production line
according to the dosage form (solution, injection, cream ..etc).

48

List of other Manufacturing site (s) subsidiary/contracted with the company

S.N.

Name of Site

City/
Country

activities occurring at this

site

3. Details of the Local Distributor

Name of Medical Store:

Address

Emirate:

City:
Postal Code:

Contact person:

Tel:

Fax:

49

Type of Quality

Email:
Medical Store License No.:
Expiry Date :
Is the Local distributor different than local authorized representative? YES

No

If YES, please fill the below mentioned detail of local authorized representative

A. Details of the Local Authorized Representative

Name of establishment :
Business Registration No.
Is your Establishment registered with Ministry of Health (Scientific Office)

No

YES

Address
Emirate:

City:
Postal Code:

Contact person qualified (please attach his qualifications according to the guideline):
Tel:

Fax:

Email:
Power of Attorney authorizing the Local authorization Holder is enclosed ?

YES

No

B. Quality Management System (QMS)

1. Please tick below the standards with which the QMS complies:

ISO 9001: 2000

ISO 13485:1996

ISO 13485:2003

Good Manufacturing Practice

50

Others, please specify.

Name of certification body & its validity :

2. Type of an established Quality Management System?

Full Quality Management System (design, production post production process,etc)

Partial quality management system

If full management quality system please mention the name and type of certification, & if partial
quality management system, please specify the scope.

3. Does the manufacturer outsource any process (e.g., design & Development,
manufacturing, warehousing, sterilization, etc.)

Yes

No

If yes please fill the information mentioned below:

Name of Facility
Address
City:

Country:
Postal Code:

Enter the details of Conformity Assessment Body approval of quality system for sterilization or
measuring function relevant to the device(s)

*Please list any Certifications currently held by company

51

Type Certification

Certified by:

1.
2.
3.
4.
5.

D. Countries that Devices are approved and sold

Devices Name
Country

(Please list five devices from

different authorities if available)

Authority that issued the approval for

marketing

1.
2.
3.
4.
5.

D.

Documentation Procedures

Describe briefly the content of each selected procedure. A copy of the documented (Glob SOP)
procedures shall be enclosed

Distribution
Record

52

Complaint
Handling

Adverse Event
Report

Recall

Alert and
Modification

E.

Products

Please give some 2-3 examples of Family devices manufactured and/marketed by your company
Please attach products list with their main description (use, and general lay name)

F.

Declaration

I hereby declare that all the information I have provided is correct and all the attached documents
are genuine; I will inform the Ministry about any changes to this information.

53

Name of company:
Name of Authorized person
Position
Signature:
Stamp of legal
manufacturer

Stamp of Local
Authorized
Representative

Date:

Annex 5
Please complete the excel file available below with the information relating to the each
device / IVD intended for listing.
Note:
A. The Company file should be submitted first, then endorsed in order the
endorsement for listing to follow.
B. Please be noted that required documents for each device/ IVD (or in group wise if
all share same features and same approval document) listed in the excel sheet
should be submitted along with its application form.
C. Each time can submit only 5 devices/ groups intended for listing
D. If the company is not sure if listing or registration applies for certain products,
they can apply for classification to the medical device committee.
E. Soft and hard copy should be attached with the required documents for each
product/ group.

Please click on the below excel file (see attached table)

54

55

Name Of Applicant
Local Authorized Representative:
Local Distributor:
List of devices / In vitro Diagnostic Kit

S.N.

Device
Proprietary/
Brand Name (for
product or
category of
products)

Class of Device

Device Description and

Its Intended Use (mention the
attachment number for
catalogue, artwork, photoetc)

Medical
Specialty Area of
use*

For device which is

sterile
and/or with measuring
function (if applicable)

Sterile
(please
tick
)
1
2
3
4
5

56

Measuring
function
(please tick
)

Annex 6
Application For Medical Device / IVD

1. DETAIL OF LOCAL DISTRIBUTOR

Authorized Distributor

Contact person

Address /Street

City:

Email::

Tel:

57

Detail of Drug Store License

Date of
Renewal

No. Of License

2. DETAIL OF THE LOCAL AUTHORIZED REPRESENTATIVE

Name

Address /Street

City

Emirate:

Postal Code

Email:

Tel:

58

3. DETAIL OF THE AUTHORIZED REPRESENTATIVE (products rights owner) IN COO /

MANUFACTURER

Name

Address /Street

City

Country

Postal Code

Email:

Tel:

4. DETAIL OF MANUFACTURING FACTILITY INVOLOVED IN THE MAUFACTURING

Name of Manufacturing
Site

Address /Street

City/Country

59

Activities occurring at this

site

60

Is the manufacturing facility registered in Registration and Drug Control Department?

Yes

No

If yes, copy of certificates is required If No, the local authorized representative should submit
all related documents along with this application
5. DETAIL OF THE DEVICE / IN VITRO DIGNOSTIC KIT
Brand Name / Family
Devices

Description
Of the Device

Qualitative and Quantitative composition (In case of Dosage Form)

S.N

Name of
Substance

Quantity

Unit

61

Reference

1
2
3
4
5
6
7
8

Class of the Device

According to the UAE
Classification

Class of the In Vitro

Diagnostic

Class 1

Class 2

Class A

Class B

62

class 3

Class C

Class 4

Class D

Type of Device

Active Device

Non Active Device
Invasive Device
In Vitro Diagnostic Kit

Description of the rule

Intended use of the

device/IVD

63

Invasive Device

Non

Contraindication
against use of the
device /IVD

User precaution

Disposal/
Environmental
Precaution

64

Cleaning /or
Sterilization
procedures
(if Applicable)

Performance & Safety

Type summary of risk
analysis conducted
(applicable for class
3,& 4)

65

Type of Test
Performance

Storage Conditions

66

Detail for Safe Handling

Condition to avoid
If applicable

67

Summary of Clinical
Evaluation
(If applicable)

Please tick the appreciate box if YES or NO

YES

The device incorporates, as an integral part, a medicinal product

which act on the human body with action ancillary to that of the
device

68

NO

The device is manufactured from or incorporating human cells/tissues/

derivatives

The device is manufactured from or incorporating animal cells/tissues/

derivatives
Please specify the classification system of the above mentioned device / In vitro diagnostic
Medical Device in other competent authorities if applicable
In case of not applicable, please tick

GHTF

Class A

Class B

EU

Class 1

Class 2a

Class 2b

Class 3

Australia

Class 1

Class 2a

Class 2b

Class AIMD

Japan

Class 1

Canada

Class 1

Class 2

Class 3

USA

Class 1

Class 2

Class 3

Singapore

Class 1

Class 2a

Class 2b

Class 2

Class C

Class 3

69

Class D

Class 4

Class 4

Class 3

Not
Applicabl
e

China

Class 1

Class 2

Class 3

Taiwan

Class 1

Class 2

Class 3

Malaysia

Class 1

Class 2

Class 3

Class 4

In vitro diagnostic Medical Device

EU

List A

List B

Self Testing Device

USA

Class 1

Class 2

Class 3

Canada

Class 1

Class 2

Class 3

Class 4

Japan

Class 1

Class 2

Class 3

Class 4

Not
Applicabl
e

Others, Please specify:

70

Marketing Approval Status in other countries (please tick the appropriate boxes if applicable)
Please attach evidence in registration file

US FDA

Pre market Approval

Supplementary

Investigational Device Exemption

510(k) Clearance

Certification for Foreign Government

EU Medical Device Directive(CE Marking)

EC Design Examination Certificate

EC Type Examination Certificate

EC Certificate for quality System/GMP

Full Quality Assurance system

Production Quality Assurance

EC Declarations of Conformity

Australia

TGA Clearance/Approval

Canada

TTP Clearance/Approval

Japan

MHLW Clearance/ Approval

Others, Please Specify

71

.
.

please tick the appropriate boxes

History

Yes

No

Yes

No

The device has been recalled in the country of origin or any country product
marketed or in progress?
The device has been revoked/ banned in the country of origin or any country
device marketed ?
Has there been any reportable adverse incidents bearing implications to the
advice?
Pro-active post market surveillance studies?
Repair & Servicing
The device is intended for single use and non repairable
The device requires regular servicing/testing/checking/calibration
Repairs and servicing provided by local authorized representative or by contracted
other party in UAE (if by other party please
Technical support provided by the manufacturer
Declaration Of Conformity (check list)

72

Submit a written Declaration of conformity states the following:

1. That device complies with Conformity assessment elements that include quality, safety
and effectiveness requirements.
2. conformity to appropriate quality systems in production and design
3. Information sufficient to identify the device including its nomenclature
4. The name and address of the device manufacturer
6. Declaration
We confirm that the information contained in our application is true and correct and that our
device are merchantable quality and fir for the purposes for which they are commonly bought.
Signature
Name
Position
Contact telephone
Date

Stamp of
Company

Annex 7
73

Essential Principles Conformity Checklist (to be attached with any application for medical devices class >>>>)
Clause

Essential Principle

Applicable

Medical devices should be designed and manufactured in such a way that, when used under
the conditions and for the purposes intended and, where applicable, by virtue of the
technical knowledge, experience, education or training of intended users, they will not
compromise the clinical condition or the safety of patients, or the safety and health of
users or, where applicable, other persons, provided that any risks which may be associated
with their use constitute acceptable risks when weighed against the benefits to the patient
and are compatible with a high level of protection of health and safety
The solutions adopted by the company and its manufacturing site for the design and
manufacture of the devices should conform to safety principles, taking account of the
generally acknowledged state of the art. When risk reduction is required, the company and
its manufacturing site should control the risks so that the residual risks associated with
each hazard is judged acceptable. The company and its manufacturing site should apply the
following principles in the priority order listed:

3
4

identify known or foreseeable hazards and estimate the associated risks arising
from the intended use and foreseeable misuse,
eliminate risks as far as reasonably practicable through inherently safe design
and manufacture,
reduce as far as is reasonably practicable the remaining risks by taking
adequate protection measures, including alarms,
Inform users of any residual risks.

Devices should achieve the performance intended by the company and its manufacturing
site and be designed, manufactured and packaged in such a way that they are suitable for
one or more of the functions within the scope of the definition of a medical device.
The characteristics and performances referred to in Clauses 1 2,3 and 4 should not be
74

Method of Conformity

Identify of
Specific
Documents

adversely affected to such a degree that the health or safety of the patient or the user
and, where applicable, of other persons are compromised during the lifetime of the
device, as indicated by the manufacturer, when the device is subjected to the stresses
which can occur during normal conditions of use and has been properly maintained in
accordance with the manufacturers instructions.

6
7
7.1

The devices should be designed, manufactured and packed in such a way that their
characteristics and performances during their intended use will not be adversely affected
under transport and storage conditions (for example, fluctuations of temperature and
humidity) taking account of the instructions and information provided by the manufacturer
The benefits must be determined to outweigh any undesirable side effects for the
performances intended.

Design and Manufacturing Requirements

Chemicals, Physical and biological
The devices should be designed and manufactured in such a way as to ensure the
characteristics and performance referred to in Clauses 1 to 6 of the General
Requirements. Particular attention should be paid to:

7.2

7.3

The choice of materials used, particularly as regards toxicity and, where

appropriate, flammability,
The compatibility between the materials used and biological tissues, cells,
body fluids, and specimens, taking account of the intended purpose of the device.
The choice of materials used should reflect, where appropriate, matters such as
hardness, wear and fatigue strength.
The devices should be designed, manufactured and packed in such a way as to minimize the
risk posed by contaminants and residues to the persons involved in the transport, storage
and use of the devices and to patients, taking account of the intended purpose of the
product. Particular attention should be paid to tissues exposed and to the duration and
frequency of exposure.
75

7.4

7.5

7.6

7.7

The devices should be designed and manufactured in such a way that they can be used
safely with the materials, substances and gases with which they enter into contact during
their normal use or during routine procedures; if the devices are intended to administer
medicinal products they should be designed and manufactured in such a way as to be
compatible with the medicinal products concerned according to the provisions and
restrictions governing these products and that their performance is maintained in
accordance with the intended use.
Where a device incorporates, as an integral part, a substance which, if used separately, is
considered to be a pharmaceutical and which is liable to act upon the body with action
ancillary to that of the device, the safety, quality and usefulness of the substance should
be verified, taking account of the intended purpose of the device.
The devices should be designed and manufactured in such a way as to reduce as far as
reasonably practicable and appropriate the risks posed by substances that may leach or
leak from the device.
Devices should be designed and manufactured in such a way as to reduce as far as
reasonably practicable and appropriate risks posed by the unintentional ingress or egress
of substances into or from the device taking into account the device and the nature of the
environment in which it is intended to be used.

Infection and Microbial Contamination

The devices and manufacturing processes should be designed in such a way as to eliminate
or to reduce as far as reasonably practicable and appropriate the risk of infection to
patients, users and, where applicable, other persons. The design should:

8.1

allow easy handling, and, where necessary:

reduce as far as reasonably practicable and appropriate any microbial leakage
from the device and/or microbial exposure during use,
Prevent microbial contamination of the device, or specimen where applicable,
by the patient, user or other person.
76

8.2

8.3

8.4

8.5

8.6

8.7

Where a device incorporates substances of biological origin, the risk of infection must be
reduced as far as reasonably practicable and appropriate by selecting appropriate sources,
donors and substances and by using, as appropriate, validated inactivation, conservation,
and test and control procedures.
Where a device incorporates tissues, cells and substances of non-human origin, such
tissues, cells and substances should originate from animals that have been subjected to
veterinary controls and surveillance adapted to the intended use of the tissues.
Information on the geographical origin of the animals should be retained. Processing,
preservation, testing and handling of tissues, cells and substances of animal origin should
be carried out so as to provide optimal safety. In particular, safety with regard to viruses
and other transmissible agents should be addressed by implementation of validated
methods of elimination or inactivation in the course of the manufacturing process.
Where a device incorporates human tissues, cells and substances, the selection of sources,
donors and/or substances of human origin, the processing, preservation, testing and
handling of tissues, cells and substances of such origin should be carried out so as to
provide optimal safety. In particular, safety with regard to viruses and other transmissible
agents should be addressed by implementation of validated methods of elimination or
inactivation in the course of the manufacturing process.
Devices labeled as having a special microbiological state should be designed, manufactured
and packed to ensure they remain so when placed on the market and remain so under the
transport and storage conditions specified by the Manufacturer.
Devices delivered in a sterile state should be designed, manufactured and packed in a nonreusable pack, and/or according to appropriate procedures, to ensure that they are sterile
when placed on the market and remain sterile, under the transport and storage conditions
indicated by the manufacturer, until the protective packaging is damaged or opened.
Devices labeled either as sterile or as having a special microbiological state should have
been processed, manufactured and, if applicable, sterilized by appropriate, validated
methods.
77

8.8

8.9

8.10
9

9.1

Devices intended to be sterilized should be manufactured in appropriately controlled (e.g.

environmental) conditions.
Packaging systems for non-sterile devices should keep the product without deterioration at
the level of cleanliness stipulated and, if the devices are to be sterilized prior to use,
minimize the risk of microbial contamination; the packaging system should be suitable
taking account of the method of sterilization indicated by the manufacturer.
The packaging and/or label of the device should distinguish between identical or similar
products placed on the market in both sterile and non-sterile condition.

Manufacturing and Environmental Properties

If the device is intended for use in combination with other devices or equipment, the
whole combination, including the connection system should be safe and should not impair
the specified performance of the devices. Any restrictions on use applying to such
combinations should be indicated on the label and/or in the instructions for use.
Devices should be designed and manufactured in such a way as to remove or reduce as far
as reasonably practicable and appropriate:
the risk of injury, in connection with their physical features, including the
volume/pressure ratio, dimensional and where appropriate ergonomic features;

9.2

risks connected with reasonably foreseeable external influences or

environmental conditions, such as magnetic fields, external electrical and
electromagnetic
effects,
electrostatic
discharge,
pressure,
humidity,
temperature or variations in pressure and acceleration;
the risks connected to their use in conjunction with materials, substances and
gases with which they may come into contact during normal conditions of
use;
the risks of accidental penetration of substances into the device;
78

 the risk of incorrect identification of specimens;

the risks of reciprocal interference with other devices normally used in the
investigations or for the treatment given;
risks arising where maintenance or calibration is not possible (as with implants),
from ageing of materials used or loss of accuracy of any measuring or control
mechanism.

9.3

Devices should be designed and manufactured in such a way as to minimize the risks of fire
or explosion during normal use and in single fault condition. Particular attention should be
paid to devices whose intended use includes exposure to or use in association with
flammable substances or substances which could cause combustion.

9.4

Devices must be designed and manufactured in such a way as to facilitate the safe disposal
of any waste substances.

10

Devices with a diagnostic or measuring function

10.1

10.2

10.3
10.4

Devices with a measuring function, where inaccuracy could have a significant adverse
effect on the patient, should be designed and manufactured in such a way as to provide
sufficient accuracy, precision and stability for their intended purpose of the device. The
limits of accuracy should be indicated by the manufacturer.
Diagnostic devices should be designed and manufactured in such a way as to provide
sufficient accuracy, precision and stability for their intended use, based on appropriate
scientific and technical methods. In particular the design should address sensitivity,
specificity, trueness, repeatability, and reproducibility, control of known relevant
interference and limits of detection, as appropriate.
Where the performance of devices depends on the use of calibrators and/or control
materials, the traceability of values assigned to such calibrators and/or control materials
should be assured through a quality management system.
Any measurement, monitoring or display scale should be designed in line with ergonomic
79

principles, taking account of the intended purpose of the device.

10.5
11
11.1
11.1.1
11.2

11.2.1

11.2.2
11.3
11.3.1
11.4
11.4.1

Wherever possible values expressed numerically should be in commonly accepted,

standardized units, and understood by the users of the device.

Protection against radiation

General
Devices should be designed and manufactured and packaged in such a way that exposure of
patients, users and other persons to any emitted radiation should be reduced as far as
practicable and appropriate, compatible with the intended purpose, whilst not restricting
the application of appropriate specified levels for therapeutic and diagnostic purposes.
Intended radiation
Where devices are designed to emit hazardous, or potentially hazardous, levels of visible
and/or invisible radiation necessary for a specific medical purpose the benefit of which is
considered to outweigh the risks inherent in the emission, it should be possible for the
user to control the emissions. Such devices should be designed and manufactured to ensure
reproducibility of relevant variable parameters within an acceptable tolerance.
Where devices are intended to emit potentially hazardous, visible and/or invisible
radiation, they should be fitted, where practicable, with visual displays and/or audible
warnings of such emissions.
Unintended radiation
Devices should be designed and manufactured in such a way that exposure of patients,
users and other persons to the emission of unintended, stray or scattered radiation is
reduced as far as practicable and appropriate.
Instructions for use
The operating instructions for devices emitting radiation should give detailed information
as to the nature of the emitted radiation, means of protecting the patient and the user
and on ways of avoiding misuse and of eliminating the risks inherent in installation.
80

11.5
11.5.1

11.5.2

11.5.3

12

12.1

Ionizing radiation
Devices intended to emit ionizing radiation should be designed and manufactured in such a
way as to ensure that, where practicable, the quantity, geometry and energy distribution
(or quality) of radiation emitted can be varied and controlled taking into account the
intended use.
Devices emitting ionizing radiation intended for diagnostic radiology should be designed
and manufactured in such a way as to achieve appropriate image and/or output quality for
the intended medical purpose whilst minimizing radiation exposure of the patient and
user.
Devices emitting ionizing radiation, intended for therapeutic radiology should be designed
and manufactured in such a way as to enable reliable monitoring and control of the
delivered dose, the beam type and energy and where appropriate the energy distribution
of the radiation beam.

Requirements for medical devices connected to or equipped with an energy source

Devices incorporating electronic programmable systems, including software, should be
designed to ensure the repeatability, reliability and performance of these systems
according to the intended use. In the event of a single fault condition in the system,
appropriate means should be adopted to eliminate or reduce as far as practicable and
appropriate consequent risks.

12.2

Devices where the safety of the patients depends on an internal power supply should be
equipped with a means of determining the state of the power supply

12.3

Devices where the safety of the patients depends on an external power supply should
include an alarm system to signal any power failure.

12.4

Devices intended to monitor one or more clinical parameters of a patient should be

equipped with appropriate alarm systems to alert the user of situations which could lead
to death or severe deterioration of the patient's state of health.
81

12.5

12.6

12.7

13
13.1

13.2

13.3

13.4
13.5

Devices should be designed and manufactured in such a way as to reduce as far as

practicable and appropriate the risks of creating electromagnetic interference which could
impair the operation of this or other devices or equipment in the usual environment.
Devices should be designed and manufactured in such a way as to provide an adequate
level of intrinsic immunity to electromagnetic disturbance to enable them to operate as
intended
Protection against electrical risks:
Devices should be designed and manufactured in such a way as to avoid, as far as possible,
the risk of accidental electric shocks during normal use and in single fault condition,
provided the devices are installed and maintained as indicated by the manufacturer

Protection against mechanical risks

Devices should be designed and manufactured in such a way as to protect the patient and
user against mechanical risks connected with, for example, resistance to movement,
instability and moving parts.
Devices should be designed and manufactured in such a way as to reduce to the lowest
practicable level the risks arising from vibration generated by the devices, taking account
of technical progress and of the means available for limiting vibrations, particularly at
source, unless the vibrations are part of the specified performance.
Devices should be designed and manufactured in such a way as to reduce to the lowest
practicable level the risks arising from the noise emitted, taking account of technical
progress and of the means available to reduce noise, particularly at source, unless the
noise emitted is part of the specified performance.
Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy
supplies which the user has to handle should be designed and constructed in such a way as
to minimize all possible risks.
Accessible parts of the devices (excluding the parts or areas intended to supply heat or
reach given temperatures) and their surroundings should not attain potentially dangerous
82

temperatures under normal use.

14
14.1

14.2

14.3

15

15.1

15.2

15.3

Protection against the risks posed to the patient by supplied energy or substances
Devices for supplying the patient with energy or substances should be designed and
constructed in such a way that the delivered amount can be set and maintained accurately
enough to guarantee the safety of the patient and of the user.
Devices should be fitted with the means of preventing and/or indicating any inadequacies
in the delivered amount which could pose a danger. Devices should incorporate suitable
means to prevent, as far as possible, the accidental release of dangerous levels of energy
from an energy and/or substance source
The function of the controls and indicators should be clearly specified on the devices.
Where a device bears instructions required for its operation or indicates operating or
adjustment parameters by means of a visual system, such information should be
understandable to the user and, as appropriate, the patient

Protection against the risks posed to the patient for devices for self-testing or self-administration
Such devices should be designed and manufactured in such a way that they perform
appropriately for their intended purpose taking into account the skills and the means
available to users and the influence resulting from variation that can reasonably be
anticipated in users technique and environment. The information and instructions
provided by the company and its manufacturing site should be easy for the user to
understand and apply
Such devices should be designed and manufactured in such a way as to reduce as far as
practicable the risk of use error in the handling of the device and, if applicable, the
specimen, and also in the interpretation of results.
Such devices should, where reasonably possible, include a procedure by which the user can
verify that, at the time of use that the product will perform as intended by the
manufacturer
83

16
16.1

Information supplied by the manufacturer

Users should be provided with the information needed to identify the manufacturer, to use
the device safely and to ensure the intended performance, taking account of their training
and knowledge. This information should be easily understood.

17

Performance evaluation including, where appropriate, clinical evaluation

17.1

All data generated in support of performance evaluation should be obtained in accordance

with the relevant requirements applicable in the countries where the data are gathered.

17.2

Clinical investigations on human subjects should be carried out in accordance with the
spirit of the Helsinki Declaration. This includes every step in the clinical investigation from
first consideration of the need and justification of the study to publication of the results.

Signature:
Name
Position
Date

I declare that the Information provided in this form is accurate and correct and the device conforms to all the applicable requirements stipulated above.

84

Annex 8
Table 1: the arrangement of the product (Medical Device)
registration application file:
Required Documents

Attachment

Application Form

The application to place a medical device on the U A E market must

be made by the device manufacturer or its authorized representative in
country of origin, signed and stamped by the company

Regulatory Approval

1.Free Sale certificate or certificates, documentation and letters of

regulatory approval and C E certification/ clearance to manufacture,
sell, import and export the medical device from competent authority in
Export country
2.All relevant documents, summary data and objective evidence which
have been used to obtain approval or clearance, if available;
Note: All certificates, documentation and letters of regulatory
approval/clearance to manufacture, sell, import and export the
medical device to UAE

Post-market requirement / vigilance system and risk

assessment)
Provide evidence of established procedures and systems for Distribution
Records, Complaint Handling, Adverse Incident Reporting and Recall

Status of device distribution

list of countries where it is marketed, details of the regulatory status

(e.g. marketing approval, product recall, product ban, etc.) obtained in
each country, a summary of the mandatory reported problems with
the device since the introduction of the device in the market.

Device Information

1.
2.
3.
4.
5.

Intended Use
Indications
Instructions of Use
Contraindications
Warnings
85

6.
7.
8.
9.
10.

Precautions
Potential Adverse Events
Device Labeling
Alternative Therapy
Device labeling which include physicians manual, pack labeling and
promotional material
11. A general description of the device and detailed description of the
device attributes;

Labeling
Three copies (artwork) of the each product Packaging, labeling and
promotional material

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.

- For single use medical devices must be labeled on outer pack label
with SINGLE USE.

Declaration of Conformity / Evidence of Conformity to

Essential principles

**G

1. Manufacturers declaration that the medical device complies with the

quality, safety and effectiveness requirements. Any certification to
demonstrate this compliance should also be submitted, together with
any summary technical files containing objective evidence on the safety
and effectiveness of the medical device;
2. Any declaration of product conformity to appropriate product
certification. For example, CE mark; Copies of certification and
document certifying conformity to appropriate quality systems in
production and design.(e.g. EC Design Examination Certificate)
3. Fill the Checklist appended as Annex 7

Safety and effectiveness data

H.1: Safety and Effectiveness Data

H.2: Risk Assessment
H.3: Pre-clinical and clinical studies

86

H.4: Biocompatibility
H.5 special requirements For Devices Containing Biological Material
H.6: Literature studies

Manufacturing Process

Special requirements for Medical Devices manufactured from

or incorporating viable or non-viable animal tissue or their
derivative(s)./ If devices contain biological materials, copies of

documented validated manufacturing processes and certification of

appropriate veterinary controls and surveillance adapted to the intended
use of the materials;

87

Table 2: the required attachment per Device Class:

Class I/ General IVD

A

Class I / General IVD (class

A)
(Sterile and/or with
Measuring Function)

Class II/
Class B IVD

Class III/
class C IVD/
Self-testing IVD

Class IV/
Class D IVD

Not Applicable

Not Applicable

Not Applicable

Not Applicable

E1

E1

E1-8

E1-11

E1-11

G
F. Self Declaration

G
Self Declaration

G. All certificates and

documents certifying
conformity to the
aspects of manufacture
relating to sterility
and metrology

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Not Applicable

88