MINISTRY OF HEALTH & POPULATION

CENTRAL ADMINISTRATION OF PHARMACEUTICAL S

AFFAIR

About us- 1
Department Activities- 2
How we regulate- 3
Publication section- 4
Post-market - 5
surveillance
Recalls- 6
7-Committees
: OnlineService- 8
Questions*
Complaints*
FAQs- 9
Contact us - 10

1
 Short Brief
 The importance of medical devices department comes from the fact that
it concerns with medical devices safety, conformity to internationally
recognized standards, and their safe performance to insure patients and
medical devices operators and users safety.
 The medical devices department is also concerned with medical devices
of personnel use or home use such as glucometer, blood pressure devices
…etc.
Mission & Aims
 The Medical device department’s mission is to enhance and safeguard
the health of the public by ensuring that medical devices work, and are
acceptably safe.
 We keep watch over devices, and we take any necessary action to
protect the public promptly if there is a problem.
 We aim to make as much information as possible publicly available.
 We enable greater access to products, and the timely introduction of
innovative treatments and technologies that benefit patients and the
public.
 We encourage everyone - the public and healthcare professionals as well
as industry - to tell us about any problems with medical device, so that
we can investigate and take any necessary action.
 Members of staff of the Medical device department together with the
assistance of committees and individual experts review the scientific
aspects of the application and reach a conclusion on the likely balance
of any benefits versus risk of the product before arriving at a decision.

 Assessing the safety, quality and efficacy of medical devices, and

authorising their sale or supply in the market for human use;
 Ensuring compliance of medical devices with International standards

2
 Within the Medical Devices Department there are two sections details of
which can be found on the website:

1- Medical device registration department.

2- Medical device release department

About Medical Devices

 The term 'medical device' covers all products, except medicines, used in
healthcare for the diagnosis, prevention, monitoring or treatment of
illness or disability.
 The Medical device department is responsible for the regulation of
medical devices on the Egyptian market. The range of products is very
wide. Many thousands of items used each and every day by healthcare
providers and patients.

There are three types of medical devices outlined in the legislation. They
are as follows:

 General medical devices

 Active implantable medical devices

 In-vitro diagnostic medical device

 Medical devices are divided into classes dependent on risk which can be
low, medium and high risk.

 The principle legislation covering medical devices is:

 Directive 90/385/EEC concerning Active Implantable Medical Devices

(AIMDD).
 Directive 93/42/EEC concerning General Medical Devices (MDD).
Directive 98/79/EC concerning In-vitro Diagnostic Medical Devices
(IVDs).
 A number of key guidance notes have been prepared to assist the
medical device sector on the use of the Directives and related
Regulations. In addition a number of application forms have been
prepared to ensure that all data required by the Medical device

3
 department is included with correspondence. These documents can be
found on the publications section of the website.

What is a medical device?

 The term 'medical device' covers all products, except medicines, used in
healthcare for the diagnosis, prevention, monitoring or treatment of
illness or disability. The range of products is very wide: it includes
contact lenses and condoms; heart valves and hospital beds;
resuscitators and radiotherapy machines; surgical instruments and
syringes; wheelchairs and walking frames or other assistive technology
products - many thousands of items used each and every day by
healthcare providers and patients.
 The list of items here is not comprehensive but shows the wide range of
products that are considered to be medical devices:

 Anaesthetic equipment
 Blood warming cabinets
 Catheters (for example, urinary, cardiac)
 Chiropody equipment
 Dental equipment and materials
 Dressings
 Endoscopes
 Examination gloves
 Implants - powered and non-powered (e.g. implantable defibrillators,
pacemakers, heart valves, orthopaedic prostheses, bone cements)
 IV administration sets and pumps
 Ophthalmic equipment
 Patient monitoring equipment (e.g. cardiac monitors)
 Physiotherapy equipment
 Radiotherapy equipment (brachytherapy external beam)
 Sphygmomanometers
 Surgical instruments and equipment
 Syringes and needles
 Thermometers
 Vaginal specula
 X-ray systems, ultrasound imagers and CT/MR scanners
 For patient transportation or moving (but not including ambulance
vehicles themselves):

Carry chairs, Lifting aids, Stretchers and trolleys.

 For critical care:

Defibrillators, Resuscitators, Ventilators.

 For people with a disability:

4
 Orthotic and prosthetic appliances, Patient hoists, Pressure relief
equipment, Walking aids, Wheelchairs and special support seating.

 For daily living:

Hearing aids, Incontinence products, Prescribable footwear, Special

chairs, Urine drainage systems

 Medical devices and equipment also include the following in vitro

diagnostic medical devices and their accessories:

Blood gas analyzers, Devices for blood glucose measurement, Hepatitis

and HIV test kits, Pregnancy test kits, Specimen collection tubes, Urine
test strips

 Also included are:

 Condoms
 Contact lenses and care products
 Intra-uterine devices (IUDs)
 We are also interested in products which, whilst not themselves medical
devices, are used closely in conjunction with these devices. For example:
 Bench top sterilizers
 Blood and tissue storage systems
 Chemical and biological indicators used in sterilization processes
 Disinfecting and sterilizing equipment.

Medical device Registration Department

 The Medical Device Registration department is in charge of evaluation,
classification, registration and licensing of sterile single-use, locally
produced or imported medical device
 It is also in charge of setting up all regulation and requirements for the
registration of medical devices

 Application form for registration

 Documents should be submitted for the registration of the imported
medical device
 Documents should be submitted for the registration of the locally
manufactured medical device
 Documents should be submitted for the cases of issuing free sale
certificates, changing or updating certain items in the registration
report.

5
 ‫نموذج الطلب الخاص بتسجيل المستلزمات‬
‫الطبية والمصانع‬
‫‪Application form FOR REGISTRATION‬‬
‫السيدة الدكتورة ‪ /‬رئيس الداارة المركزية لشئون الصيدلة‬
‫تحية طيبة و بعد ‪،،،‬‬
‫برجاء الموافقة على تسجيل المنتج التالى بياناته ‪:‬‬

‫و تفضلوا بقبول ففائق الحاترام‪،،،‬‬

‫‪Applicant name‬‬
‫‪Medical device name‬‬
‫‪Codes, Models(in‬‬
‫)‪table‬‬
‫‪Pack description(in‬‬
‫)‪Arabic‬‬
‫‪Manufacturer name‬‬
‫‪Country of origin‬‬
‫‪Distributor/agent‬‬
‫‪name‬‬

‫‪6‬‬
 Application date
Medical device use (in
Arabic)
Similar medical
devices in the
Egyptian Market
:Address
:Telephone no
:Mobile no
:Email
:Fax no
Commercial register
:no
/ ‫مدير الشركة‬
‫الطلب يقدم علي ورق الشركة و يكون موقع و مختوم من المدير المسؤول‬:‫ملحوظة‬
‫او العضو المنتدب و الختم يوضح السجل التجاري‬
Documents required for registration of imported Medical Devices

200 / / ‫تحريرا فى‬

1- Application form for registration Signed& stamped from the Importing Egyptian company.
.Importer Record License of Egyptian company (Original + photocopy) - 2
.C14 in case of agency+Commercial Card (Original + Photocopy) -
Distribution /Agency Agreement between Importing Egyptian and Exporting Foreign companies -3
(Legalized by chamber of commerce and Egyptian embassy in country of origin + photocopy )
.Relation between foreign Exporter & Foreign Manufacturer in case of subcontractor -4
( Legalized by chamber of commerce and Egyptian embassy in country of origin + photocopy )
.Free Sale issued by Ministry of Health in country of origin (Latest Edition) - (Legalized + photocopy) -5
CE certificate issued from an accredited notified body (Legalized + 2 photocopies) -6 -6
If product is utilizing tissue from animal origin, CE certificate should cover 2003/32/EEC directive
.Certificate for Foreign Government issued from FDA (Legalized + 2 photocopies) -7
.ISO 13485 certificate (Legalized + photocopy)-8
.Test report certificate issued from Quality control lab /signed & stamped from the manufacturer -9
.Sterility certificate issued/signed &stamped from manufacturer -10
.Compostion Certificate acc. to international standards issued/signed &stamped from manufacturer -11
.Shelf life Certificate issued/signed &stamped from manufacturer legalized -12
.Stability Study issued/signed &stamped from manufacturer -13
.Packaging material Certificate issued/signed &stamped from manufacturer -14

7
 .Sketch diagram & dimension of product issued/signed &stamped from manufacturer -15
Sample-16
.Internal & External Label of product issued/signed &stamped from manufacturer -17
Catalogue + Inner leaflet-18
19-Declaration of conformity mentioning (product name, classification, CE certificate number, a statement th
the declaration is issued under the sole responsibility of the manufacturer) issued/signed &stamped from
manufacturer, legalized by chamber of commerce only)

N.B
The application should be followed up within 15 days from the application -1
date, and requirements should be fulfilled within 4 months from the
.application date otherwise the application is cancelled
.Six copies of the file are required to be submitted to a specialized committee -2
.The application should be accompanied by fees receipt -3
In case of Re-registration: The expired registration report should be -4
.submitted within the documents of the Re- registration file
For Registration of blood bags and detergents: 10 samples should be -5
.supplied for analysis by NODCAR
Any product with codes or references should be mentioned either in CE or -6
free sale (with the exception of codes for intraocular lenses should be
.mentioned in CE certificate)
In case of registration of medical product of class lll, free sale certificate from-7
.reference country should be supplied beside its documents

12-03-2009

Documents required for registration of local Medical Devices

1- Application form for registration Signed& stamped from the Importing Egyptian company.
.Facility License issued by Ministry of Health (Original-mention facility's activities) -2
.Facility License issued by Industrial Ministry (Original-mention facility's activities) -3
Commercial Card (Original + Photocopy) -4
Taxes Card (Original + Photocopy) -5
Declaration of conformity mentioning (product name, classification, CE certificate number, a statement that - 6
the declaration is issued under the sole responsibility of the manufacturer) issued/signed &stamped from
.(manufacturer
CE certificate issued from an accredited notified body -7 -7
.If product is utilizing tissue from animal origin, CE certificate should cover 32/2003/EEC directive
.ISO 13485 certificate -8
.Composition Certificate acc to international standards issued/signed &stamped from manufacturer -9
.Test report certificate issued from Quality control lab /signed & stamped from the manufacturer -10

8
.Sterility certificate issued/signed &stamped from manufacturer -11
.Shelf life Certificate issued/signed &stamped from manufacturer -12
.Stability Study issued/signed &stamped from manufacturer -13
.Packaging material Certificate issued/signed &stamped from manufacturer -14
.Sketch diagram & dimension of product issued/signed &stamped from manufacturer -15
.Internal & External Label of product issued/signed &stamped from manufacturer -16
Sample -17

N.B
The application should be followed up within 15 days from the application -1
date, and requirements should be fulfilled within 4 months from the
.application date otherwise the application is cancelled
.The application should be accompanied by fees receipt -2
In case of Re-registration: The expired registration report should be -3
.submitted within the document of the Re- registration file
For Registration of blood bags and detergents: 10 samples should be -4
.supplied for analysis by NODCAR
In case of manufacturer holding only ISO 13485:2003 certificate, the -5
registration report is issued for a year on condition that the manufacturer
submit NODCAR Compliance certificate and pursuit the procedure to hold
.CE certificate
In case of manufacturer holding CE & ISO 13485:2003 certificates, the -6
.registration report is issued for five years
Any product with codes or references should be mentioned either in CE -7

12-03-2009

‫ للمستلزمات الطبية‬Free Sale ‫المستندات المطلوبة للحصول على شهادة‬

(‫) المعقمة و المسجلة بوزارة الصحة‬

.‫طلب موقع و مختوم من الشركة المنتجة للحصول على شهادة التداول موضح به الدولة الصادر لها الشهادة‬-1
(‫صورة‬+‫)اصل‬.‫اخطارات التسجيل للمستلزمات الطبية‬-2
. CE & ISO 13485 ‫شهادة‬-3
.‫رخصة المصنع الصادرة من وزارة الصحة‬-4
.‫ يرفق الطلب بايصال دفع الرسوم‬-5

‫ للمستلزمات الطبية‬free sale ‫المستندات المطلوبة للحصول على شهادة‬

(‫)غير معقمة وغيرمسجلة بوزارة الصحة‬

‫طلب موقع و مختوم من الشركة المنتجة للحصول على شهادة التداول موضح به الدولة الصادر‬--1
.‫لها الشهادة‬
:‫ من الشركة المنتجة )موقع و مختوم( و يشمل‬Declaration -2
(‫*اسم المستلزم الطبى)السم التجارى‬

9
 ‫*‪classification‬‬
‫*اسم المصنع المنتج‬
‫‪-3‬شهادة ‪ ISO 13485‬للمصنع المنتج‪).‬اصل‪+‬صورة(‬
‫‪ -4‬رخصة المصنع الصادرة من وزارة الصحة‪) .‬اصل‪+‬صورة(‬
‫‪-5‬خطاب من المصنع المنتج يفيد ‪:‬‬
‫*الجهات التى يقوم بالتوريد اليها‪.‬‬
‫‪ -6‬شهادة ‪ GMP‬صادرة من ادارة تفتيش المستلزمات بالادارة المركزية للشئون الصيدلية‪.‬‬
‫‪-7‬عينة من المستلزمات الطبية المتداولة فى السوق المصرى ‪.‬‬
‫‪ --8‬يرفق الطلب بايصال دفع الرسوم‪.‬‬

‫المستندات المطلوبة للحصول على خطاب اضافة بلد منشأ‪) :‬اصل‪+‬صورة(‬

‫‪-1‬طلب موقع و مختوم من الشركة المستوردة لضافة بلد منشأ جديدة للمستلزم الطبى المسجل بوزارة الصحة‪.‬‬
‫‪-2‬شهادة ‪ ( (Free sale or FDA‬لبلد المنشأ المراد اضافتها موثقة من السفارة و الغرفة التجارية‪.‬‬
‫‪-3‬شهادة ‪ CE‬للمصنع المنتج موثقة من السفارة و الغرفة التجارية ‪.‬‬
‫‪-4‬علقة بين فروع الشركة المنتجة معتمدة من الغرفة التجارية‪.‬‬
‫‪-5‬خطاب من الشركة المنتجة يفيد عدم وجود اى تغيير فى المنتج من حيث المواد الخام ‪،‬مدة الصلحية‪،‬التغليف و‬
‫التعبئة‪،‬التعقيم‪،‬التحليل‪،‬دراسة الثبات و ان التغيير فى مكان التصنيع فقط‪).‬معتمد من الغرفة التجارية(‬
‫‪ -6‬أصل اخطار التسجيل‪.‬‬
‫‪ --7‬يرفق الطلب بايصال دفع الرسوم‪.‬‬

‫المستندات المطلوبة للحصول على خطاب تغيير اسم الشركة المنتجة‪) :‬اصل‪+‬صورة(‬

‫‪-1‬طلب موقع و مختوم من الشركة المستوردة لتغيير اسم ااشركة المنتجة للمستلزم الطبى المسجل بوزارة‬
‫الصحة‪.‬‬
‫‪-2‬خطاب من الشركة المنتجة) موثق من السفارة والغرفة التجارية( يفيد‪:‬‬
‫*تغيير اسم الشركة مع توضيح تغييرالسم)من السم القديم الى السم الجديد(‪.‬‬
‫* ذكر السماء التجارية للمنتجات‪.‬‬
‫عدم وجود اى تغيير فى المنتج من حيث المواد الخام ‪،‬مدة الصلحية‪،‬التغليف و التعبئة‪،‬التعقيم‪،‬التحليل‪،‬دراسة الثبات و *‬
‫‪.‬السم التجارى و ان التغيير فى اسم الشركة المنتجة فقط‬
‫‪.‬ترخيص قيد فى سجل المستوردين باسم الشركة الجديد‪3-‬‬
‫‪.‬أصل اخطار التسجيل ‪4-‬‬
‫‪ --5‬يرفق الطلب بايصال دفع الرسوم‪.‬‬

‫المستندات المطلوبة للحصول على خطاب يفيد بنقل اخطارات التسجيل من وكيل الى اخر‪):‬اصل‬
‫‪ +‬صورة(‬

‫‪-1‬طلب موقع و مختوم من الشركة المستوردة )الوكيل الجديد( لنقل اخطارات التسجيل باسم شركته ‪.‬‬
‫‪-2‬خطاب من الشركة المنتجة)موثق من السفارة والغرفة التجارية( يفيد نهاية العقد مع الوكيل القديم)‬
‫‪.(termination letter‬‬
‫‪-3‬عقد وكالة )موثق من السفارة والغرفة التجارية( بين الشركة المنتجة و الشركة المستوردة )الوكيل الجديد(‪.‬‬

‫‪10‬‬
 ‫‪-4‬محضر انهاء الوكالة صادر من الدارة المركزية للشئون الصيدلية‪.‬‬
‫‪-5‬ترخيص القيد فى سجل مستوردى المستلزمات الطبية للوكيل الجديد صادر من الدارة المركزية للشئون‬
‫الصيدلية‪.‬‬
‫‪-6‬س ‪14‬‬
‫‪ -7‬خطاب موقع و مختوم من الوكيل القديم بالتنازل عن اخطارات التسجيل للوكيل الجديد‪.‬‬
‫‪ -8‬أصل اخطار التسجيل‪.‬‬
‫‪ -9‬يرفق الطلب بايصال دفع الرسوم‪.‬‬

‫المستندات المطلوبة للحصول على خطاب اضافة الكواد ‪) :‬اصل‪+‬صورة(‬

‫‪-1‬طلب موقع و مختوم من الشركة المستوردة لضافة الكواد الجديدة للمستلزم الطبى المسجل بوزارة الصحة‪.‬‬
‫‪-2‬شهادة ‪ ( (Free sale or FDA‬للكواد المراد اضافتها موثقة من السفارة و الغرفة التجارية‪.‬‬
‫‪-3‬شهادة ‪ CE‬للمصنع المنتج موثقة من السفارة و الغرفة التجارية ‪.‬‬
‫‪-4‬خطاب من الشركة المنتجة يفيد عدم وجود اى تغيير فى المنتج من حيث المواد الخام ‪،‬مدة الصلحية‪،‬التغليف و‬
‫التعبئة‪،‬التعقيم‪،‬التحليل‪،‬دراسة الثبات‪،‬وبيانات العبوات الداخلية والخارجية‪).‬معتمد من الغرفة التجارية(‬
‫‪ -5‬أصل اخطار التسجيل‪.‬‬
‫‪ -6‬يرفق الطلب بايصال دفع الرسوم‪.‬‬

‫المستندات المطلوبة للحصول على خطاب اضافة عبوة ‪) :‬اصل‪+‬صورة(‬

‫‪-1‬طلب موقع و مختوم من الشركة المستوردة لضافة العبوة الجديدة للمستلزم الطبى المسجل بوزارة الصحة‪.‬‬
‫‪-2‬خطاب من الشركة المنتجة يفيد عدم وجود اى تغيير فى المنتج من حيث المواد الخام ‪،‬مدة الصلحية ‪،‬التعقيم‪،‬‬
‫مادة التغليف ‪،‬التحليل‪،‬دراسة الثبات‪،‬وبيانات العبوات الداخلية والخارجية وذكر العبوات التى سيتم إضافتها‪).‬معتمد‬
‫من الغرفة التجارية(‬
‫‪-3‬أصل اخطار التسجيل‪.‬‬
‫‪ -4‬يرفق الطلب بايصال دفع الرسوم‪.‬‬
‫من الغرفة التجارية(‬

‫مرفق خاص بالمطهرات و ‪ blood bags‬مع طلبات تسجيل‬

‫المستلزمات الطبية المستوردة‬
‫طلبات خاصة للرقابة الدوائية‬
‫بالمطهرات و ‪Blood bags‬‬
‫‪.Formula-1‬‬
‫‪.Packs-2‬‬
‫‪.Finished product specification-3‬‬
‫‪.Raw material specification (active + excepients)-4‬‬
‫‪.Certificate of analysis-5‬‬
‫استمارة ‪-176‬‬
‫‪.Method of analysis – validation-7‬‬
‫‪samples of the product 8-10‬‬

‫‪11‬‬
Medical device Release Department
 The Medical Device Release department is in charge of evaluation,
classification, and authorizing the sale or supply in the market for
human use of all medical devices either locally produced or imported
 Application form.
 Documents should be submitted for the registration of the imported
medical device.
 Documents should be submitted for the release of the locally
manufactured medical device.

12
‫نموذج الطلب الخاص بالفاراج عن المستلزمات‬
‫والجاهزة الطبية والمصانع والسانان‬

‫السيدة الدكتورة ‪ /‬رئيس الداارة المركزية لشئون الصيدلة‬

‫تحية طيبة و بعد ‪،،،‬‬
‫نرجو من سياداتكم الموافقة عن مشمول الففاتورة و بيانها كالتا‬

‫رقم الفاتورة‬
‫مبلغ الفاتورة‬
‫الشركة الموردة‬
‫بلد المنشأ‬
‫مشمول الفاتورة‬
‫عدد صفحات الفاتورة‬

‫‪13‬‬
 ،،،‫و تفضلوا بقبول ففائق الحاترام‬

/ ‫مدير الشركة‬
/ ‫التوقيع‬
/‫الختم‬
‫الطلب يقدم علي ورق الشركة و يكون موقع و مختوم من المدير المسؤول‬:‫ملحوظة‬
‫او العضو المنتدب و الختم يوضح السجل التجاري‬

200 / / ‫تحريرا فى‬

Documents required for the Release of Local Medical Devices

Formal Request (Product name, Facility Name, Country of Origin, Similar medical devices in -1
.the Egyptian Market) Signed& stamped from the manufacturer

. Facility License issued by Ministry of Health (Original/ Include the facility's activities) -2
.Facility License issued by Industrial Ministry (Original/ Include the facility's activities) -3
Commercial Card Original + Photocopy -4
Taxes Card Original + Photocopy -5
.copies of Performa Invoice 2 -6
.Certificate of origin -7
Declaration of conformity issued/signed &stamped from manufacturer, mentioning name of -6
product, intended use, classification, CE certificate number ,a statement that the declaration is
.(issued under the sole responsibility of the manufacturer
.ISO 13485 certificate--9
7- CE certificate issued from an accredited notified body), mentioning the brand name of product
if the product contains any animal origin, the CE certificate should include 32/2003/EEC *
.directive
The registration report in case of the registered medical device (for sterile single use medical -11
.device)
.Catalogue -16
N.B

14
 The status of the file should be followed up within 72 hours only from date of
.application to fulfill its requirements

Documents required for the release of imported Medical Devices

Formal Request (Product name, Company Name, Country of Origin)-1

.Signed& stamped from the importing company
In case of medical device,(3)copies of Proforma Invoice -2
.In case of dental devices, 10 copies of Proforma Invoice
+Importer Record License(Original)of Egyptian company.+ photo copy+ photocopy of agreement-3
C14 in case of agents +Commercial Card Original + Photocopy
Distribution /Agency Agreement) between importing Egyptian and exporting foreign company ,in -4
case the foreign company is not added in Importing license.(Original & Legalized by chamber of
commerce and Egyptian embassy in foreign company.+ photo copy.)
Relation between foreign Exporter &foreign Manufacturer (Original& Legalized) (in case -5
.subcontractor or broker) +photo copy
:required certificates -6

Free Sale issued by ministry of health (Original & Legalized) +2photo copy, With recent issuance, -1
.including the trade name of medical device

CE certificate issued from European notified body with medical directive 93/42/EEC +2 photocopies -2
(Original & Legalized) and if product contain any animal origin CE certificate should include the
.2003/32/EEC directive

.FDA (Original) + 2 photocopies (if product origin from USA, including the trade name of product) -3

declaration of conformity, issued/signed &stamped from manufacturer, mentioning the name of -7

product, classification, CE certificate number, upon responsibility of manufacturer, issued/signed

15
 &stamped from manufacturer. legalized by chamber of commerce only
ISO 13485 certificate original ,legalized + photocopy--8
ISO 13485 certificate original ,legalized + photocopy--8
Release Work
.The registration report for the registered medical device (for sterile single use medical device) -9
Flow
.catalogue to show the medical device-10
:N.B
The status of the file should be followed up within 72 hours only from date of *
.application to fulfill its requirements

Copies of the file of the new devices that are imported to Egypt for the first *
time are required to be submitted to a specialized committee to have their
.opinions about the quality and efficacy of these new devices

00:3 ot ma 00:9 morf noitacilppa eliF -1

mp
yadsendeW-yadnoM -yadrutaS

latneD fo snoitacilppA
d lacidem derutcafunam lacidem detropmi fo snoitacilppA
secived

niam eht gnillifluf seliF

rebmun laires ekat stnemeriuqer.

16
 Registration Work
Flow
First Reviewer-2
Study submitted documents and
.certificates

If the requirements are not fulfilled,

.If requirements are fulfilled
the file will be suspended

The final report is issued, taking Company Report is issued with the
whole requirements to be
.the final number
.completed

Final Reviewer-3
Review submitted documents and certificates
.

Suspended until the notes is fulfilled

Accepted

lavorppA noitatropmI
deussi sI.

00:3 ot ma 00:9 morf noitacilppa eliF -1

mp
yadsendeW-yadnoM -yadrutaS

tneD fo snoitacilppA
cidem derutcafunam
lacidem detropmi fo snoitacilppA
secived

u dewollof eb dluohs sutats elif ehT

a fo etad eht morF
uow elif eht esiwrehto noitacilppa fo.

17
In case the requirement of the registering
When the requirement is fulfilled
file is not fulfilled within the maximum
period of 4 months from the date of
application, the file would be rejected

reganaM lareneG yb weiver dnoceS

eussI troper noitartsigeR

-Dental committee: All applications of Dental medical devices is referred to a

weekly dental committee.
-Medical device committees: is applied according to the device case.

Under construction

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Under construction

Questions
Complaints

FAQs (Frequently Asked Questions)

Question: What is an accessory to a medical device?
Answer:

An article which whilst not being a device is intended specifically by its

manufacturer to be used together with a device to enable it to be used in accordance
with the use of the device intended by the manufacturer of the device.

Question: What is a CE Mark?

Answer:

The CE mark that appears on a medical device or on its packaging means that the
device satisfies the relevant essential requirements and is fit for its intended purpose
as specified by the manufacturer. All medical devices, (except custom-made
devices and those intended for clinical investigations) must bear a CE mark.

Question: What is a class I medical device manufacturer?

Answer:

Any person who manufactures, for the purpose of placing on the market, a medical
device that is classified as a class I device according to the medical devices
directive. Class I devices are deemed to carry the lowest risk and so class I
manufacturers self-declare conformity with the medical devices directive.

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Question: What is conformity assessment for medical devices?
Answer:

Conformity assessment is the process of demonstrating a medical devices

compliance with the Requirements of the relevant Directive. How conformity is
demonstrated varies according to the class of the device. All devices except class I
medical devices (non-sterile/no measuring function) must undergo conformity
assessment by a notified body for medical devices.

Question: What is a Conformity Assessment Body for medical devices?

Answer:

Conformity assessments for medical devices are conducted, when required, by

conformity assessment bodies that have been specifically notified to the
Commission i.e. notified bodies. Notified bodies are designated by a designating
authority to carry out conformity assessments to the Medical Device, AIMD or IVD
directives.

The activities carried out by notified bodies include reviewing technical files and
design dossiers for devices, auditing manufacturing facilities and products,
assessing changes, issuing, suspending or withdrawing certificates, and conducting
manufacturer/product reviews/audits on an ongoing basis.

Medical device manufacturers can chose any notified body to conduct a conformity
assessment of a medical device provided that the device is within the scope of
designation.

Question: What is a custom-made medical device manufacturer?

Answer:

A person who specifically makes any device in accordance with a duly qualified
Practitioner’s written prescription which gives, under their responsibility, specific
design characteristics and is intended for sole use of a particular patient.

The prescription for a custom made device must be completed by a person

authorized by virtue of their professional qualifications to do so.

Mass-produced devices which need to be adapted to meet the specific requirements

of the medical practitioner or any other professional user are not considered to be
custom-made devices.

Question: What are devices for self-testing?

Answer:

This term generally is applied to in-vitro diagnostic devices which are intended by
the manufacturer to be able to be used by lay persons in a home environment

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Question: What is an importer of a medical device?
Answer:

An importer (a person responsible for placing on the market) is any natural or legal
person established in the Community who places a product from a third country on
the Community market.

Question: What does the term 'intended purpose' mean in relation to a medical
device?
Answer:

The use for which the device is intended according to the data supplied by the
manufacturer on the labelling, in the instructions and/or in promotional materials

Question: What is a Notified Body?

Answer:

Notified Bodies are part of the regulatory system established by the Medical Device
Directives. They are usually certification bodies with relevant expertise that are
responsible for ensuring that the conformity assessment procedures are followed by
the manufacturer as well as establishing that devices conform to the relevant
essential requirements of the Directives and also to established standards in design
and production. Such bodies may be privately or state owned and must be notified
formally to the European Commission for the purposes of the Directives by their
relevant CA once they have demonstrated that they have met the criteria set out in
the annexes to the Directives. They issue the approval to the CE marking of
conforming medical devices and they may be notified for some or all of the
conformity assessment procedures described in the annexes.

Question: What information should appear on the label of a medical device?

Answer:
All medical devices must be labelled in accordance with the requirements of the
legislation and related standards, e.g. ISO- 15223-1-2007: medical devices -
Symbols to be used with medical device labels, labelling and information to be
supplied - Part 1: General requirements.

Question: What determines the class of a device?

Answer:
General medical devices and active implantable medical devices are classified so
that the level of regulatory control is proportionate to the degree of risk associated
with the device.

The classification rules applied by manufacturers are listed in the Medical Devices
Directives and are based on several factors. These factors include the intended use
of the product as assigned by the manufacturer, its mode of action, the duration of
contact with the patient, the degree of invasiveness, the anatomy affected by the

21
device, whether it is active and the claims made about the product. The
manufacturer must be able to substantiate all claims made about the product.
In-vitro diagnostic devices are grouped using a positive listing system into general
IVDs, devices for self-testing, Annex II List A or List B..

Question: What is meant by Declaration of Conformity?

Answer
5-Declarations of Conformity:

The declaration must be drawn up by either:

 The manufacturer (wherever located in the world); or

 The manufacturer's authorized representative in the European Community.

The meaning of "manufacturer" and "authorized representative" is not specifically

defined but the generally understood meanings apply. In addition, anybody who
brands products for supply under their own name (whether or not they actually
made them) or who modifies products with or without re-branding may become
the "manufacturer" for the purposes of the directive. Where products are not
manufactured or placed on the market, then the person who puts the product into
service will usually be considered the manufacturer. Exceptionally, where none of
these parties has taken responsibility, the importer or supplier may be considered
the manufacturer for the purposes of enforcing the directive.

An authorized representative in the Community must be designated by the

manufacturer and must therefore be able to demonstrate some legal / commercial
arrangement with the manufacturer. The authorized representative may be an
individual or a company. A manufacturer outside the Community is not obliged to
appoint an authorized representative. A distributor or other commercial
representative does not automatically become the authorized representative.

In all cases, the person signing the declaration must be in a position to know on
behalf of the manufacturer that the product complies with the requirements of the
directive based on the design, manufacture, testing and production control of the
products concerned. The responsibility is that of the manufacturer (or authorized
representative) not of the person signing. The signatory must therefore be in a
position to bind the manufacturer or the authorized representative in legal
obligations.

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 Cont./ Declaration of conformity definition.

What is the minimum content?

There is no minimum content, or indeed, any particular content for a declaration

set out However, it is clear that in order to fulfil its purpose it must include at
least:

 a description of the product or products to which it relates which is clear

enough to identify the product available in the market;
 a declaration that the requirements of Directive 1999/5/EC are complied
with;
 identification of the manufacturer or authorised representative;
 the name and signature of the person accepting responsibility on behalf of
the manufacturer or authorised representative; and
 effective date / date of signature.

What about additional recommended content?

The authorities will usually expect to see more than the minimum content
above. Typically, in addition to the above, this is likely to include:

 a list of any standards used in establishing compliance with the

requirements– particularly if they are European harmonised standards for
the purposes of that directive;
 where harmonised standards are not used, the reference of the technical
construction file that was used to establish compliance;
 identification of any notified body involved and a reference to the opinion
given by them; and
 a statement that the declaration is issued under the sole responsibility of
the manufacturer or authorised representative.

 Suggested form for the Declaration of Conformity.

Tel:
Fax:
Email:Dppc-meddev@hotmail.com

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