Medical Devices Into The Register Of Medical Devices Of The

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					                              MINISTRY OF HEALTH

  Pursuant to Article 131 paragraph 3 of the Law on Medicinal Products and Medical
Devices (Official Gazette of the Republic of Macedonia No. 106/07 and 88/10), the
Minister of Health hereby adopts a

Rulebook On The Content Of The Template For The Request And The Supporting
Documentation To Be Submitted For Entering Medical Devices Into The Register
             Of Medical Devices Of The Republic Of Macedonia

                                 I. General Provision

                                     Article 1
   This Rulebook shall prescribe the content of the template for the request and the
necessary supporting documentation to be submitted for entering medical devices
into the Register of Medical Devices of the Republic of Macedonia (hereinafter
referred to as: the Register).

             II. Templates for the Request for Entry into the Register

                                         Article 2
   The templates for the request for entering medical devices into the Register that are
submitted to the Drug Agency (hereinafter referred to as: the Agency) by a manufacturer
of medical devices, a legal representative of a foreign manufacturer (with a concluded
representation contract), a branch of a foreign manufacturer and a trade agency of a
foreign manufacturer, that have registered headquarters in the Republic of Macedonia
and valid insurance covering the territory of the Republic of Macedonia, shall be:
   - The template for the request for entering class I medical devices into the
Register of Medical Devices of the Republic of Macedonia (Template No.1),
   - The template for the request for entering medical devices of classes II-a, II-b and
III into the Register of Medical Devices of the Republic of Macedonia (Template
No.2),
    - The template for the request for entering in vitro diagnostic medical devices
into the Register of Medical Devices of the Republic of Macedonia (Template
No.3), and
   - The template for the request for entering AIMD medical devices into the Register
of Medical Devices of the Republic of Macedonia (Template No.4).

                                        Article 3
   The template for the request for entering medical devices of class I into the Register
of Medical Devices of the Republic of Macedonia (Template No.1), the template for the
request for entering medical devices of classes II-a, II-b and III into the Register of
Medical Devices of the Republic of Macedonia (Template No.2) and the template for
the request for entering AIMD medical devices into the Register of Medical
Devices of the Republic of Macedonia (Model No.3) shall contain the following
data:


I. DATA ON THE PERSON SUBMITTING THE REQUEST
    - Full name of the person submitting the request,
    - Headquarters/address, city, telephone, fax, e-mail
    - Responsible person for entering the medical device into the Register,
    name, surname and profession, telephone, fax, e-mail,
    - Manufacturer
   - Representative
   - Agent

II. DATA ON THE MEDICAL DEVICE
     1. Name of the medical device
       - Proprietary name,
       - General group name,
       - Intended purpose and brief description,
     2. Type of application
       - First entry into the Register
       - Alterations /Appendages
       - Renewal of entry into the Register.
           In the case of alterations, the archival number of the first application or
       the first alteration shall be cited, as well as the alteration or appendage for
       which the request is being submitted, as follows:
       1. the name, i.e. address of the manufacturer of the medical devices,
       2. the name, i.e. address of the person submitting the request,
       3. the person submitting the request,
       4. the name of the medical device,
       5. the manufacturer of the input components of the medical device,
       6. a new manufacturing location for parts or all of the procedures of the
       manufacturing process of the finished product, cited in the certificate,
       7. the procedure of testing the finished product (alteration of standards and
       methods),
       8. the appearance and manner of marking the external, i.e. the internal
       designations,
       9. the form, package or dimensions of the medical device,
       10. the class to which the medical device belongs,
       11. the date of expiry,
       12. the storage conditions,
       13. the manner of dispensing, i.e. selling, and
       14. the place of dispensing, i.e. selling of the medical device, archival number
       and date of issuing the decision.
     3. The class to which the medical device belongs.

III. DATA ON THE MANUFACTURER OF THE MEDICAL DEVICES
     1. Manufacturer in the Republic of Macedonia
       - Full name of the manufacturer
       - Headquarters / address, city, telephone, fax, e-mail
       - List of eventual manufacturers under contract
     2. Manufacturer in the European Union
       - Full name of the manufacturer,
       - Headquarters/address, city, telephone, fax, e-mail
       - Manufacturing location (full name and address as indicated in the certificate),
       - Quality system certificate EN ISO 13485
       issued by:
       certificate No:
       expires on: ,
       - List of eventual manufacturers under contract with a description of the part of
       the manufacturing process being carried out
     3. Manufacturer out of the European Union
       - Full name of the manufacturer,
       - Headquarters/address, city, telephone, fax, e-mail
       - Manufacturing location (full name and address as indicated in the certificate),
       - Quality system certificate EN ISO 13485 issued by:
     certificate No:
     expires on: ,
     - Name of an authorised representative in the EU
     - Address, city/country, telephone, fax, e-mail
     - List of eventual manufacturers under contract with a description of the part of
     the manufacturing process being carried out,
     - Certificate number
     - medical devices whose manufacture is commissioned for a certain patient,
     - medical devices intended for clinical examinations,
     - medical devices consisting of several products bearing the EC conformity
     mark,
     - medical devices consisting of products some of which do not bear the EC
     conformity mark,
     - medical devices solely sterilised and placed on the market by the manufacturer
     under his/her own name.

IV. CATEGORIES OF MEDICAL DEVICES
      - code – category of the medical device,
      - 1 – active implantable devices,
      - 2 – anaesthetic and respiratory devices,
      - 3 – dental devices,
      - 4 – electro-mechanical devices,
      - 5 – technical hospital equipment,
      - 6 – in vitro diagnostic devices,
      - 7 – inactive implantable devices,
      - 8 – ophthalmological optical devices,
      - 9 – non-disposable instruments,
      - 10 – non-reusable devices,
      - 11 – technical devices for the disabled,
      - 12 – diagnostic and therapeutical radiology devices.

V. STATEMENT OF THE PERSON RESPONSIBLE TO THE PERSON
SUBMITTING THE REQUEST
   - Name, surname and function of the person responsible to the person submitting the
   request,
   - Name, signature and stamp of the legal entity.

                                    Article 4
   The template for the request for entering in vitro diagnostic medical devices
into the Register of Medical Devices of the Republic of Macedonia (Template
No.3) shall contain the following data:

III. DATA ON THE PERSON SUBMITTING THE REQUEST
      - Full name of the person submitting the request,
      - Headquarters/address, city, telephone, fax, e-mail
      - Name, surname and profession, telephone, fax and e-mail of the person
      responsible for entering the medical device into the Register,
      - Manufacturer
      - Representative
      - Agent.

II. DATA ON THE MEDICAL DEVICE
     1. Name of the medical device
       - Proprietary name,
     - General group name,
     - Intended purpose and brief description,
   2. Type of application
     - First entry into the Register
     - Alteration/Appendage
     - Renewal of entry into the Register
         In the case of alterations, the archival number of the first application or
     the first alteration shall be cited, as well as the alterations and appendages
     for which the request is being submitted, as follows:
     1. the name, i.e. address of the manufacturer of the medical devices,
     2. the name, i.e. address of the person submitting the request,
     3. the person submitting the request,
     4. the name of the medical device,
     5. the manufacturer of the input components of the medical device,
     6. a new manufacturing location for parts or all of the procedures of the
     manufacturing process of the finished product, cited in the certificate,
     7. the procedure of testing the finished product (alteration of standards and
     methods),
     8. the appearance and manner of marking the external, i.e. the internal
     designations,
     9. the form, package or dimensions of the medical device,
     10. the class to which the medical device belongs,
     11. the date of expiry,
     12. the storage conditions,
     13. the manner of dispensing, i.e. selling, and
     14. the place of dispensing, i.e. selling of the medical device, archival number
     and date of issuing the decision.
   3. The classification of in vitro diagnostic medical devices shall be as follows:
     - List A products
     - List B products
     - Self-testing products
     - Other products.

III. DATA ON THE MANUFACTURER OF THE MEDICAL DEVICES
     1. Manufacturer in the Republic of Macedonia
       - Full name of the manufacturer
       - Headquarters/address, city, telephone, fax, e-mail
       - List of eventual manufacturers under contract

   2. Manufacturer in the European Union
     - Full name of the manufacturer,
     - Headquarters/address, city, telephone, fax, e-mail
     - Manufacturing location (full name and address as indicated in the certificate),
     - Quality system certificate EN ISO 13485 issued by:
     certificate No:
     expires on: ,
        - List of eventual manufacturers under contract with a description of the part
     of the manufacturing process being carried out
   3. Manufacturer out of the European Union
     - Full name of the manufacturer,
     - Headquarters/address, city, telephone, fax, e-mail
     - Manufacturing location (full name and address as indicated in the certificate),
     - Quality system certificate EN ISO 13485 issued by:
     certificate No:
     expires on: ,
     - Name of an authorised representative in the EU
     - Address, city/country, telephone, fax, e-mail
         - List of eventual manufacturers under contract with a description of the part
     of the manufacturing process being carried out,
   4. Grouping of in vitro diagnostic medical devices:
     - Code, type - reagent, reagent products, calibrators, control material, set/kit,
     instrument, apparatus, equipment, composition, sampling kit, vacuum sampling
     kit, products for general laboratory equipment, kit),
     - Certificate number
     - Name and identification number of the body for conformity evaluation,
     - medical devices whose manufacture is commissioned for a certain patient,
     - medical devices intended for clinical examinations,
     - medical devices consisting of several products bearing the EC conformity
     mark,
     - medical devices consisting of products some of which do not bear the EC
     conformity mark,
     - medical devices solely sterilised and placed on the market by the manufacturer
     under his/her own name.

IV. CATEGORIES OF MEDICAL DEVICES
     - code – category of the medical device,
     - 1 – active implantable devices,
     - 2 – anaesthetic and respiratory devices,
     - 3 – dental devices,
     - 4 – electro-mechanical devices,
     - 5 – technical hospital equipment,
     - 6 – in vitro diagnostic devices,
     - 7 – inactive implantable devices,
     - 8 – ophthalmological optical devices,
     - 9 – non-disposable instruments,
     - 10 – non-reusable devices,
     - 11 – technical devices for the disabled,
     - 12 – diagnostic and therapeutical radiology devices.



V. STATEMENT OF THE PERSON RESPONSIBLE TO THE PERSON
SUBMITTING THE REQUEST
    - Name, surname and function of the person responsible to the person submitting
    the request,
    - Name, signature and stamp of the legal entity.

                                         Article 5
   The documentation to be submitted for entering medical devices into the Register
shall consist of a request containing:
   1. an accompanying letter for entering the medical devices in the Register,
   2. a completed form relating to entering the medical device into the
Register under the appropriate category or class,
   3. evidence of insurance against side-effects caused by using the medical
device – an insurance policy and a statement
   4. documentation on the medical device in accordance with this Rulebook, and
   5. evidence of payment of prescribed expenses for entering the medical
devices into the Register
   The person submitting the request shall accompany the request with samples
of the medical devices.
   The statement referred to in paragraph 1 item 3 of this Article shall be enclosed
herein and shall be a constituent part of this Rulebook.
                                         Article 6
The accompanying letter referred to in Article 5 paragraph 1 item 1 of this Rulebook shall
contain:
    1. the logo, name and address of the person submitting the request,
    2. the subject of the request,
    3. the name, generic name, form, size, dimensions of the medical device, etc. with
    specific explanations,
    4. a proposal concerning the package of the medical device,
    5. the name of manufacturer,
    6. a proposal concerning the manner of dispensing the medical devices with a
    proposal of the location thereof, and
    7. the date and signature of the person responsible for the procedure of entering
    the medical devices into the Register.
   The accompanying letter may concern several requests for entering medical
devices into the Register.

                                          Article 7
   The documentation referred to in Article 5 paragraph 1 item 4 of this Rulebook, when
relating to medical devices containing an EC-conformity certificate, shall contain:
   1. a declaration of conformity by the manufacturer (Declaration of conformity);
   2. an EC-conformity certificate (with the exception of medical devices of class I
and other in vitro diagnostic medical devices);
    3. quality system certificate EN ISO 13485
   4. evidence that the medical device in on the market in the country of the
manufacturer (Free sale certificate),
   5. evidence of insurance against side-effects caused by using the medical
device – an insurance policy and a statement
   6. a contract for representation concluded between the manufacturer and the legal
representative of the foreign manufacturer with registered headquarters in the
Republic of Macedonia, along with evidence that it fulfils the requirements for
wholesaling medical devices or that it is a branch of a foreign manufacturer or trade
agency of a foreign manufacturer and evidence that it fulfils the manufacturing
requirements for domestic manufacturers;
   In addition to the information referred to in paragraph 1 of this Article, the
documentation for medical devices containing an EC-conformity certificate shall also
contain:
  - data on the name and address of the person submitting the request,
  - the name and address of the manufacturer and the manufacturing location,
  - the name of the medical device (name and generic name);
  - all types and models (variants) of the medical device;
  - product specifications: composition in terms of quantity and quality (if necessary),
  - data on the proposed expiry date and manner of storage of the medical
  device,
   - certificate for analysis of the finished product for an individual lot of the
medical device,
   - a proposal for marking the external and internal package in Macedonian
language and its Cyrillic script,
   - instructions for patients – users of products of foreign origin in English language
and a proposal for instructions for use of the medical device of foreign and domestic
origin in Macedonian language and its Cyrillic script signed by a clinical doctor, i.e. an
expert.

                                       Article 8
   The documentation referred to in Article 5 paragraph 1 item 4 of this Rulebook, when
relating to medical devices that lack an EC-conformity certificate, shall contain
administrative data and data on the quality, safety and efficiency of the medical device,
as follows:
Administrative data shall contain:
   - data on the name and address of the person submitting the request,
   - the name and address of the manufacturer and the manufacturing location,
    - evidence that the medical device in on the market in the country of the
manufacturer (Free sale certificate),
    - data on classifying the medical device according to the International
Classification of Medical Devices (the GMDN or EDMA code)
    - evidence of insurance against side-effects caused by using the medical device
– an insurance policy and a statement
    - a contract for representation concluded between the manufacturer and the legal
representative of the foreign manufacturer with registered headquarters in the
Republic of Macedonia, along with evidence that it fulfils the requirements for
wholesaling medical devices or that it is a branch of a foreign manufacturer or a
trade agency of a foreign manufacturer and evidence that it fulfils the
manufacturing requirements for domestic manufacturers.
Data on the quality, safety and efficiency shall contain:
    - description of the medical device (name and generic name, brief description and
the declared purpose of the medical device),
    - name of the medical device (name, generic name, brief description, the
declared purpose of the product);
- all types and models (variants) of the medical device;
    - product specification: composition in terms of quantity and quality (if necessary),
data on the material if of human or animal origin (if necessary);
    - specific data on in vitro diagnostic medical devices (sensitivity, specificity, linearity,
measuring scope, precision and accuracy, etc.);
   - a brief description of the manufacturing process;
   - a certificate for analysis of the finished product with the methods and standards
used,
    - for medical devices that come into contact with the human body, data on the
biological evaluation of the medical device in accordance with adopted standards
    - EMC/ES and other tests and certificates of the medical apparatus;
    - data on the proposed expiry date and manner of storage of the medical device;
    - a proposal for marking the external and internal package,
    - instructions for patients – users of products of foreign origin, signed by an
expert,
    - data on the risk analysis of products of classes IIb and III, AIMD, as well as
medical devices of lists A and B – in vitro diagnostic medical devices,
    - for medical devices of classes IIa, IIb and III, clinical data or data on expert
bibliography or results of clinical research on the basis of which the Agency forms
its opinion on the efficiency of the medical device.

                                        Article 10
   The experts’ opinion on the efficiency of the medical device on a part of the
documentation of medical devices referred to in Article 9 paragraph 3 indent 14 of
this Rulebook shall contain:
    - data on the expert who draws up the expert opinion,
    - references to individual parts of the documentation or bibliography data
    concerning the efficiency of the medical device,
    - a summary of the expert opinion in writing with a concluding statement of the
    expert who drew up the opinion,
    - signature of the expert who drew up the opinion, and
    - date on which the opinion was drawn up.

                                    Article 11
   The documentation on the medical device referred to in Article 5 paragraph 1 item 4
of this Rulebook shall be submitted in writing to the Agency.
   The person submitting the request may submit the documentation on the
medical device in the form of a copy of the original, unless provided otherwise
by this Rulebook.
   If the person submitting the request submits a copy of the documentation on the
medical device, he/she shall also submit a written statement to the Agency
confirming the reliability of the copies of the original documentation.
   One copy of the documentation on medical devices shall be submitted.

                                    Article 12
   A request for entering an alteration or appendage into the Register shall be
submitted for all new findings regarding the evaluation of the quality, safety and
efficiency of medical devices.

                                         Article 13
The alterations and appendages entered into the Registry shall concern:
     1. the name, i.e. address of the manufacturer of the medical devices,
     2. the name, i.e. address of the person submitting the request,
     3. the person submitting the request,
     4. the name of the medical device,
     5. the manufacturer of the input components of the medical device,
     6. a new manufacturing location for parts or all of the procedures of the
     manufacturing process of the finished product, cited in the certificate,
     7. the procedure of testing the finished product (alteration of standards and
     methods),
     8. the appearance and manner of marking the external, i.e. the internal
     designations,
     9. the form, package or dimensions of the medical device,
     10. the class to which the medical device belongs,
     11. the date of expiry,
     12. the storage conditions,
     13. the manner of dispensing, i.e. selling, and
     14. the place of dispensing, i.e. selling of the medical device.

                                         Article 14
  The documentation to be submitted for entering medical devices into the
Register or appending the Register shall consist of a request containing:
     1. an accompanying letter written by the person submitting the request,
     2. a completed form for alterations or appendages relating to the appropriate
     class, i.e. the class of the medical device,
     3. documentation relating to the alteration or the appendage and containing
     sufficient information for its assessment, and
     4. evidence of payment of the prescribed allowances.

                                       Article 15
The accompanying letter referred to in Article 14 item 1 of this Rulebook shall contain:
     1. the logo, name and address of the person submitting the request,
     2. subject: an application or a request for amending or appending the Register
     of Medical Devices,
     3. the name of the medical device (name, generic name, form, size, dimensions
     in all variations). The name of the medical device shall be identical with the one
     cited in the form and in the documentation,
     4. package of the medical device,
     5. the name of manufacturer, and
     6. date and signature of the person responsible for the procedure of
submitting the application for amending or appending the Register of Medical
Devices.
        The accompanying letter shall concern only one alteration or appendage,
with the exception of cases where the alteration or appendage occurred due to
certain circumstances, in which case the accompanying letter shall contain all
alterations or appendages.

                                     Article 16
   When entering an alteration or an appendage into the Register, the person
submitting the request may make references to the documentation referred to in
Articles 7 and 8 of this Rulebook, submitted on first entering the medical device
into the Register of Medical Devices in the Agency, referred to in Articles 7 and
8 of this Rulebook, if it has undergone no changes.

                                     Article 17
   The request for entering the renewal into the Register shall be submitted to the
Agency within 90 days at the latest before the expiration of the period for entering it
into the Register.


                                      Article 18
  The documentation to be submitted for entering renewals into the Register shall
consist of a request containing:
     1. an accompanying letter written by the person submitting the request,
     2. a completed form relating to entering the renewal into the Register under
     the appropriate category or class of the medical device,
     3. documentation on the medical device prescribed by this Rulebook, and
     4. evidence of payment of the prescribed allowances.

                                       Article 19
The accompanying letter referred to in Article 18 of this Rulebook shall contain:
     1. the logo, name and address of the person submitting the request,
     2. the name, i.e. generic name of the medical device,
     3. the form and package of the medical device (size and dimensions),
     4. the name of manufacturer,
     5. the date and number of the previous entry into the Register, i.e. the
     approval of putting into circulation, and
     6. the date and signature of the person responsible for the procedure of
     entering the renewal into the Register of Medical Devices.

                                       Article 20
  The documentation on the medical device referred to in Articles 14 and 18 of this
Rulebook shall contain updated administrative data and documents, as follows:
     1. a declaration of conformity (Declaration of conformity),
     2. an EC-conformity certificate (with the exception of medical devices of class I
     and in vitro diagnostic medical devices),
     3. quality system certificate EN ISO 13485,
     4. evidence that the medical device in on the market in the country of the
     manufacturer (Free sale certificate),
     5. evidence of insurance against side-effects caused by the application of the
     medical device, and
     6. other data upon request of the Agency, depending on the type of medical
     device.
                                   Article 21
   The documentation on the medical devices prescribed by this Rulebook shall be
submitted in writing.
  One copy of the documentation referred to in paragraph 1 of this Article shall be
submitted.

                                        Article 22
   The entry into the Register of medical devices that have an EC-conformity
certificate shall be valid until the date on which the conformity certificate, i.e. the
EC-conformity certificate expires.
   The entry into the Register of medical devices that do not have an EC-
conformity certificate shall be valid depending on the type of medical devices:
   - 3 years for medical devices of classes I, IIa, in vitro diagnostic medical devices and
diagnostic self-testing devices,
   - 2 years for medical devices of classes IIb and in vitro diagnostic medical devices
from List B,
   - 1 year for medical devices of classes III, AIMD and in vitro diagnostic medical
devices from List A.

                                       Article 23
The templates No. 1, 2, 3 and 4 shall be attached herein and shall be a constituent part
of this Rulebook.

                                   II. Final provision

                                        Article 24
  This Rulebook shall enter into force on the eighth day from the date of its
publication in the Official Gazette of the Republic of Macedonia.

No. 15-6710/1                                                                 Minister,
15 November 2010                                                     Dr Bujar Osmani
Skopje
                                                                TEMPLATE NO.1

TEMPLATE FOR THE REQUEST FOR ENTERING MEDICAL DEVICES OF
CLASS I INTO THE REGISTER OF MEDICAL DEVICES OF THE REPUBLIC
OF MACEDONIA

I. DATA ON THE PERSON SUBMITTING THE REQUESTFull name of the
person submitting the
request
Headquarters/address
city
telephone
fax
e-mail
Responsible person for
entering the medical
device into
the Register
name, surname and
profession:
telephone
fax
e-mail

   Please indicate the status of the person submitting the request

          •   Manufacturer
          •   Representative
          •   Agent

II. DATA ON THE MEDICAL DEVICE
   1. Name of the medical device
   (If all the remaining data of the template are the same, a request for several
   medical devices may be submitted with a separate template for each name)
Proprietary name
General group name
Intended purpose and brief description
    2. Please indicate the type of request
                  First entry into the Register
                  Alteration/Appendage
                Renewal of the entry into the Register
   If the request concerns an alteration, please indicate the archival number of the
   the first application or the first alteration and from among the alterations and
   appendages mentioned below, indicate the alteration which the request relates to.
   1. alteration of the name, i.e. the address of the manufacturer of medical devices,
   2. alteration of the name, i.e. the address of the person submitting the request,
   3. alteration of the person submitting the request,
   4. alteration of the name of the medical device,
   5. alteration of the manufacturer of the input components of the medical device,
   6. alteration, termination or appendage of/to a new manufacturing location for
   one part or all the procedures of the manufacturing process of the finished
   product, indicated in the certificate.
   7. alteration of the procedure of examining the finished product (alteration of
   standards and methods),
   8. alteration of the appearance and manner of marking the external, i.e. the
   internal designation,
   9. alteration or appendage of the form, package or dimension of the medical
   device,
   10, alteration of the class of the medical device,
   11. alteration of the date of expiry,
   12. alteration of the storage conditions,
   13.alteration of the manner of dispensing, i.e. selling, and
   14. alteration of the place of dispensing, i.e. selling of the medical device.
   If a previous decision on the medical device has been issued, please indicate the
   archival number and date of issuance of the decision
archival number and date of issuance of
the decision
   3. Please indicate the class to which the medical device belongs
         • Class I
         • Class I – sterile products
         • Class I – measuring instrument



III. DATA ON THE MANUFACTURER OF THE MEDICAL DEVICES
1. Manufacturer in the Republic of Macedonia
Full name of the manufacturer
Headquarters / address
city
telephone
fax
e-mail
List of eventual manufacturers under contract

2. Manufacturer in the European Union
     Full name of the manufacturer
Headquarters / address
city
telephone
fax
e-mail
Manufacturing location (full name and
address of the certificate):
Certificate for the EN quality system
ISO 13485
issued by:
certificate No:
expires on:
List of eventual manufacturers under
contract with a description of the
manufacturing being performed
3. Manufacturer out of the European Union
Full name of the manufacturer
Headquarters / address
city
telephone
fax
e-mail
Manufacturing location (full name and
address of the certificate):
Certificate for the EN quality system
ISO 13485
issued by:
certificate No:
expires on:
Name of authorised EU representative
address
city/country
telephone
fax
e-mail
List of eventual manufacturers under
contract with a description of the
manufacturing being performed
Please include data on the body competent for evaluating the conformity and which issued
the conformity certificate of the sterilisation procedure or the measuring functions of the
medical device

Certificate number




Please indicate if the medical device belongs to the group of medical devices designed for a
special purpose
                        medical devices
                        whose
                        manufacture is
                        commissioned for
                        a certain patient
                        medical
                        device
                        intended for
                        clinical
                        examination
Please indicate if the medical device belongs to the group of medical devices that constitute a
set or a system
                        medical device
                        consisting of
                        several products
                        bearing an EC
                        conformity mark

                        medical device
                        consisting of
                        products some of
                        which do not bear
                        an EC conformity
                        mark


                        medical device
                        which is only
                        sterilised and put
                        into circulation
                        under his/her name
                        by the manufacturer


IV. CATEGORY OF THE MEDICAL DEVICES
The medical devices shall be classified into only one category.
code category of the medical device                                      please indicate
1     active implantable devices
2     anaesthetic and respiratory devices
3     dental devices
4     electrical-mechanical devices
5     technical hospital equipment
6     in vitro diagnostic devices
7      inactive implantable devices
8     ophthalmological optical devices
9     non-disposable instruments
10    non-reusable devices
11    technical devices for the disabled
12    diagnostic and therapeutic radiology devices


V. STATEMENT OF THE PERSON RESPONSIBLE TO THE PERSON SUBMITTING THE
REQUEST
I, the undersigned, hereby confirm that:

   • The information relating to the request for entering the medical device of class I into the
      Register is reliable and the medical device of class I conforms to the prescribed
      regulations. I hereby undertake the responsibility to inform the Drug and Medical
      Devices Agency of any alterations regarding the medical device
   • I will monitor any undesirable side-effects and I will inform the Agency in accordance with the
      regulations
   • The submitted documentation is identical to that which has been submitted before the
      competent body in the EU
   • The registered activity is performed with a simultaneous protection of public health in
      accordance with existing regulations
Name, surname and function of the person responsible to the person submitting the request
(as indicated in the Central Registry of the Republic of Macedonia)
Name of the legal entity _______________________________________________
Signature _____________________________date _________________________
Stamp of the legal entity _______________________________________________


Name, surname and function of the person responsible to the person submitting the request
(for monitoring undesirable side-effects)
Name of the legal entity ______________________________________________
Signature _____________________________date ________________________
Stamp of the legal entity _____________________________________________


This template shall not be altered in any way
Правилник за содржината на образецот на барањето и потребната документација која треба да
се достави за запишување на медицинските помагала во Регистарот на медицински помагала
на Република Македонија 151/10; преведувач: Трајанка Кортова; TCU; датум: 22.03.2011


                                                                   TEMPLATE NO.2

TEMPLATE FOR THE REQUEST FOR ENTERING MEDICAL DEVICES OF
CLASSES IIa, IIb AND III INTO THE REGISTER OF MEDICAL DEVICES OF
THE REPUBLIC OF MACEDONIA

I. DATA ON THE PERSON SUBMITTING THE REQUESTFull name of the
person submitting the
request
Headquarters/address
city
telephone
fax
e-mail
Responsible person for
entering the medical
device into
the Register
name, surname and
profession:
telephone
fax
e-mail

   Please indicate the status of the person submitting the request

           •   Manufacturer
           •   Representative
           •   Agent

II. DATA ON THE MEDICAL DEVICE
   1. Name of the medical device
   (If all the remaining data of the template are the same, a request for several
   medical devices may be submitted with a separate template for each name)
Proprietary name
General group name
Intended purpose and brief description
     2. Please indicate the type of request
                  First entry into the Register
                  Alteration/Appendage
                Renewal of the entry into the Register
   If the request concerns an alteration, please indicate the archival number of the
   the first application or the first alteration and from among the alterations and
   appendages mentioned below, indicate the alteration which the request relates to.
Правилник за содржината на образецот на барањето и потребната документација која треба да се
достави за запишување на медицинските помагала во Регистарот на медицински помагала на
Република Македонија 151/10; преведувач: Трајанка Кортова; TCU; датум: 22.03.2011



      1. alteration of the name, i.e. the address of the manufacturer of medical devices,
      2. alteration of the name, i.e. the address of the person submitting the request,
      3. alteration of the person submitting the request,
      4. alteration of the name of the medical device,
      5. alteration of the manufacturer of the input components of the medical device,
      6. alteration, termination or appendage of/to a new manufacturing location for
      one part or all the procedures of the manufacturing process of the finished
      product, indicated in the certificate.
      7. alteration of the procedure of examining the finished product (alteration of
      standards and methods),
      8. alteration of the appearance and manner of marking the external, i.e. the
      internal designation,
      9. alteration or appendage of the form, package or dimension of the medical
      device,
      10, alteration of the class of the medical device,
      11. alteration of the date of expiry,
      12. alteration of the storage conditions,
      13. alteration of the manner of dispensing, i.e. selling, and
      14. alteration of the place of dispensing, i.e. selling of the medical device.
       If a previous decision on the medical device has been issued, please indicate the
       archival number and date of issuance of the decision
   archival number and date of issuance of
   the decision

       3. Please indicate the class to which the medical device belongs
             • Class IIa
             • Class IIb
             • Class III



   III. DATA ON THE MANUFACTURER OF THE MEDICAL DEVICES
  1. Manufacturer in the Republic of Macedonia
  Full name of the manufacturer
  Headquarters / address
  city
  telephone
  fax
  e-mail
  List of eventual manufacturers under contract

  3. Manufacturer in the European Union
       Full name of the manufacturer
  Headquarters / address
  city
  telephone
  fax
  e-mail
  Manufacturing location (full name and
  address of the certificate):
  Certificate for the EN quality system
  ISO 13485
Правилник за содржината на образецот на барањето и потребната документација која треба да се достави за
запишување на медицинските помагала во Регистарот на медицински помагала на Република Македонија
151/10; преведувач: Трајанка Кортова; TCU; датум: 22.03.2011




    issued by:
    certificate No:
    expires on:
    List of eventual manufacturers under
    contract with a description of the
    manufacturing being performed
    3. Manufacturer out of the European Union
    Full name of the manufacturer
    Headquarters / address
    city
    telephone
    fax
    e-mail
    Manufacturing location (full name and
    address of the certificate):
    Certificate for the EN quality system
    ISO 13485
    issued by:
    certificate No:
    expires on:
    Name of authorised EU representative
    address
    city/country
    telephone
    fax
    e-mail
    List of eventual manufacturers under
    contract with a description of the
    manufacturing being performed
    Please include data on the body competent for evaluating the conformity and which issued
    the conformity certificate of the sterilisation procedure or the measuring functions of the
    medical device

    Certificate number

    Certificate number

    Name and identification number of the body evaluating the conformity

    Please indicate if the medical device belongs to the group of medical devices designed for a
    special purpose
                             medical devices
                             whose
                             manufacture is
                             commissioned for
                             a certain patient
                            medical
                            device
                            intended for
                            clinical
                            examination
    Please indicate if the medical device belongs to the group of medical devices that constitute a
    set or a system
                             medical device
                             consisting of
Правилник за содржината на образецот на барањето и потребната документација која треба да се достави за
запишување на медицинските помагала во Регистарот на медицински помагала на Република Македонија
151/10; преведувач: Трајанка Кортова; TCU; датум: 22.03.2011


                            several products bearing an
                            EC conformity mark

                            medical device
                            consisting of products
                            some of which do not
                            bear an EC conformity
                            mark


                            medical device which is
                            only sterilised and put
                            into circulation under
                            his/her name by the
                            manufacturer


  IV. CATEGORY OF THE MEDICAL DEVICES
  The medical devices shall be classified into only one category.
  code category of the medical device                                          please indicate
  1 active implantable devices
  2 anaesthetic and respiratory devices
  3 dental devices
  4 electrical-mechanical devices
  5 technical hospital equipment
  6 in vitro diagnostic devices
  7 inactive implantable devices
  8 ophthalmological optical devices
  9 non-disposable instruments
  10 non-reusable devices
  11 technical devices for the disabled
  12 diagnostic and therapeutic radiology devices


  V. STATEMENT OF THE PERSON RESPONSIBLE TO THE PERSON SUBMITTING THE
  REQUEST

      I, the undersigned, hereby confirm that:
             The information relating to the request for entering the medical device of
              classes IIa, IIb and III into the Register is reliable and the medical device of
              class IIa, IIb and III conforms to the prescribed regulations. I hereby undertake
              the responsibility to inform the Drug and Medical Devices Agency of any
              alterations regarding the medical device
             I will monitor any undesirable side-effects and I will inform the Agency in accordance
              with the regulations
             The submitted documentation is identical to that which has been submitted
              before the competent body in the EU
             The registered activity is performed with a simultaneous protection of public health in
              accordance with existing regulations
Правилник за содржината на образецот на барањето и потребната документација која треба да се достави за
запишување на медицинските помагала во Регистарот на медицински помагала на Република Македонија
151/10; преведувач: Трајанка Кортова; TCU; датум: 22.03.2011



   Name, surname and function of the person responsible to the person submitting the request
   (as indicated in the Central Registry of the Republic of Macedonia)
   Name of the legal entity _______________________________________________
   Signature _____________________________date _________________________
   Stamp of the legal entity _______________________________________________


   Name, surname and function of the person responsible to the person submitting the request
   (for monitoring undesirable side-effects)
   Name of the legal entity ______________________________________________
   Signature _____________________________date ________________________
   Stamp of the legal entity _____________________________________________


   This template shall not be altered in any way
Правилник за содржината на образецот на барањето и потребната документација која треба да
се достави за запишување на медицинските помагала во Регистарот на медицински помагала
на Република Македонија 151/10; преведувач: Трајанка Кортова; TCU; датум: 22.03.2011


                                           TEMPLATE NO.3
TEMPLATE FOR THE REQUEST FOR ENTERING IN VITRO DIAGNOSTIC
MEDICAL DEVICES INTO THE REGISTER OF MEDICAL DEVICES OF THE
REPUBLIC OF MACEDONIA

I. DATA ON THE PERSON SUBMITTING THE REQUESTFull name of the
person submitting the
request
Headquarters/address
city
telephone
fax
e-mail
Responsible person for
entering the medical
device into
the Register
name, surname and
profession:
telephone
fax
e-mail

   Please indicate the status of the person submitting the request

           •   Manufacturer
           •   Representative
           •   Agent

II. DATA ON THE MEDICAL DEVICE
   1. Name of the medical device
   (If all the remaining data of the template are the same, a request for several
   medical devices may be submitted with a separate template for each name)
Proprietary name
General group name
Intended purpose and brief description
     2. Please indicate the type of request
                  First entry into the Register
                  Alteration/Appendage
                Renewal of the entry into the Register
   If the request concerns an alteration, please indicate the archival number of the
   the first application or the first alteration and from among the alterations and
   appendages mentioned below, indicate the alteration which the request relates to.


    1. alteration of the name, i.e. the address of the manufacturer of medical devices,
    2. alteration of the name, i.e. the address of the person submitting the request,
    3. alteration of the person submitting the request,
    4. alteration of the name of the medical device,
    5. alteration of the manufacturer of the input components of the medical device,
Правилник за содржината на образецот на барањето и потребната документација која треба да се достави за
запишување на медицинските помагала во Регистарот на медицински помагала на Република Македонија
151/10; преведувач: Трајанка Кортова; TCU; датум: 22.03.2011
      6. alteration, termination or appendage of/to a new manufacturing location for one part or
      all the procedures of the manufacturing process of the finished product, indicated in the
      certificate.
      7. alteration of the procedure of examining the finished product (alteration of standards
      and methods),
      8. alteration of the appearance and manner of marking the external, i.e. the internal
      designation,
      9. alteration or appendage of the form, package or dimension of the medical device,
      10, alteration of the class of the medical device,
      11. alteration of the date of expiry,
      12. alteration of the storage conditions,
      13. alteration of the manner of dispensing, i.e. selling, and
      14. alteration of the place of dispensing, i.e. selling of the medical device.
       If a previous decision on the medical device has been issued, please indicate the archival
       number and date of issuance of the decision
   archival number and date of issuance of the
   decision


       3. Please indicate the classification of the in vitro diagnostic medical device
             • Products of list A
             • Products of list B
             • Self-testing productsOther products



   III. DATA ON THE MANUFACTURER OF THE MEDICAL DEVICES
  1. Manufacturer in the Republic of Macedonia
  Full name of the manufacturer
  Headquarters / address
  city
  telephone
  fax
  e-mail
  List of eventual manufacturers under contract

  4. Manufacturer in the European Union Full
        name of the manufacturer
  Headquarters / address
   city
  telephone
  fax
  e-mail
   Manufacturing location (full name and
  address of the certificate):
  Certificate for the EN quality system
   ISO 13485
   issued by:
  certificate No:
  expires on:
  List of eventual manufacturers under
  contract with a description of the
     manufacturing being performed
    3. Manufacturer out of the European Union
Правилник за содржината на образецот на барањето и потребната документација која треба да се достави за
запишување на медицинските помагала во Регистарот на медицински помагала на Република Македонија
151/10; преведувач: Трајанка Кортова; TCU; датум: 22.03.2011
    Full name of the manufacturer
    Headquarters / address
    city
    telephone
    fax
    e-mail
    Manufacturing location (full name and
    address of the certificate):
    Certificate for the EN quality system
    ISO 13485
    issued by:
    certificate No:
    expires on:
    Name of authorised EU representative
    address
    city/country
    telephone
    fax
    e-mail
    List of eventual manufacturers under
    contract with a description of the
    manufacturing being performed
                 4. Please indicate the group to which the in vitro diagnostic medical device
                 belongs
        code       type
                   reagent
                   reagent product
                  calibrators
                  control material
                  set/kit
                  instrument
                  apparatus
                  equipment
                  composition
                  sampling kit
                  vacuum sampling kit
                  products for general laboratory use
                  tools


    Please include data on the body competent for evaluating the conformity and which issued
    the conformity certificate of the sterilisation procedure or the measuring functions of the
    medical device

    Certificate number

    Certificate number

    Name and identification number of the body evaluating the conformity

    Please indicate if the medical device belongs to the group of medical devices designed for a
    special purpose
                             medical devices
                             whose
                             manufacture is
                             commissioned for
                             a certain patient
                             medical
Правилник за содржината на образецот на барањето и потребната документација која треба да се достави за
запишување на медицинските помагала во Регистарот на медицински помагала на Република Македонија
151/10; преведувач: Трајанка Кортова; TCU; датум: 22.03.2011
                            device
                            intended for
                            clinical
                            examination
    Please indicate if the medical device belongs to the group of medical devices that constitute a
    set or a system
                             medical device
                             consisting of several
                             products bearing an EC
                             conformity mark
                            medical device
                            consisting of products
                            some of which do not
                            bear an EC conformity
                            mark

                            medical device which is
                            only sterilised and put
                            into circulation under
                            his/her name by the
                            manufacturer


  IV. CATEGORY OF THE MEDICAL DEVICES
  The medical devices shall be classified into only one category.
  code category of the medical device                                         please indicate
  1     active implantable devices
  2     anaesthetic and respiratory devices
  3     dental devices
  4     electrical-mechanical devices
  5     technical hospital equipment
  6     in vitro diagnostic devices
  7      inactive implantable devices
  8     ophthalmological optical devices
  9     non-disposable instruments
  10    non-reusable devices
  11    technical devices for the disabled
  12    diagnostic and therapeutic radiology devices
Правилник за содржината на образецот на барањето и потребната документација која треба да се достави за
запишување на медицинските помагала во Регистарот на медицински помагала на Република Македонија
151/10; преведувач: Трајанка Кортова; TCU; датум: 22.03.2011

  V. STATEMENT OF THE PERSON RESPONSIBLE TO THE PERSON SUBMITTING THE
  REQUEST
    I, the undersigned, hereby confirm that:
      • The information relating to the request for entering in vitro diagnostic medical devices
         into the Register is reliable and the in vitro diagnostic medical device conforms to the
         prescribed regulations. I hereby undertake the responsibility to inform the Drug and
         Medical Device Agency of any alterations regarding the medical device
      • I will monitor any undesirable side-effects and I will inform the Agency in accordance with the
         regulations
      • The submitted documentation is identical to that which has been submitted before the
         competent body in the EU
      • The registered activity is performed with a simultaneous protection of public health in
         accordance with existing regulations



   Name, surname and function of the person responsible to the person submitting the request
   (as indicated in the Central Registry of the Republic of Macedonia)
   Name of the legal entity _______________________________________________
   Signature _____________________________date _________________________
   Stamp of the legal entity _______________________________________________


   Name, surname and function of the person responsible to the person submitting the request
   (for monitoring undesirable side-effects)
   Name of the legal entity ______________________________________________
   Signature _____________________________date ________________________
   Stamp of the legal entity _____________________________________________


   This template shall not be altered in any way
                                                                TEMPLATE NO.4

TEMPLATE FOR THE REQUEST FOR ENTERING AIMD MEDICAL
DEVICES INTO THE REGISTER OF MEDICAL DEVICES OF THE REPUBLIC
OF MACEDONIA

I. DATA ON THE PERSON SUBMITTING THE REQUEST
Full name of the
person submitting the
request
Headquarters/address
city
telephone
fax
e-mail
Responsible person for
entering the medical
device into
the Register
name, surname and
profession:
telephone
fax
e-mail

   Please indicate the status of the person submitting the request

          •   Manufacturer
          •   Representative
          •   Agent

II. DATA ON THE MEDICAL DEVICE
   1. Name of the medical device
   (If all the remaining data of the template are the same, a request for several
   medical devices may be submitted with a separate template for each name)
Proprietary name
General group name
Intended purpose and brief description
    2. Please indicate the type of request
                  First entry into the Register
                  Alteration/Appendage
                Renewal of the entry into the Register
   If the request concerns an alteration, please indicate the archival number of the
   the first application or the first alteration and from among the alterations and
   appendages mentioned below, indicate the alteration which the request relates to.
   1. alteration of the name, i.e. the address of the manufacturer of medical devices,
   2. alteration of the name, i.e. the address of the person submitting the request,
   3. alteration of the person submitting the request,
   4. alteration of the name of the medical device,
   5. alteration of the manufacturer of the input components of the medical device,
   6. alteration, termination or appendage of/to a new manufacturing location for
   one part or all the procedures of the manufacturing process of the finished
   product, indicated in the certificate.
   7. alteration of the procedure of examining the finished product (alteration of
   standards and methods),
   8. alteration of the appearance and manner of marking the external, i.e. the
   internal designation,
   9. alteration or appendage of the form, package or dimension of the medical
   device,
   10, alteration of the class of the medical device,
   11. alteration of the date of expiry,
   12. alteration of the storage conditions,
   13. alteration of the manner of dispensing, i.e. selling, and
   14. alteration of the place of dispensing, i.e. selling of the medical device.
   If a previous decision on the medical device has been issued, please indicate the
   archival number and date of issuance of the decision
archival number and date of issuance of
the decision
   3. Please indicate the class to which the medical device belongs
         • AIMD



III. DATA ON THE MANUFACTURER OF THE MEDICAL DEVICES
1. Manufacturer in the Republic of Macedonia
Full name of the manufacturer
Headquarters / address
city
telephone
fax
e-mail
List of eventual manufacturers under contract

5. Manufacturer in the European Union
     Full name of the manufacturer
Headquarters / address
city
telephone
fax
e-mail
Manufacturing location (full name and
address of the certificate):
Certificate for the EN quality system
ISO 13485
issued by:
certificate No:
expires on:
List of eventual manufacturers under
contract with a description of the
manufacturing being performed
3. Manufacturer out of the European Union
Full name of the manufacturer
Headquarters / address
city
telephone
fax
e-mail
Manufacturing location (full name and
address of the certificate):
Certificate for the EN quality system
ISO 13485
issued by:
certificate No:
expires on:
Name of authorised EU representative
address
city/country
telephone
fax
e-mail
List of eventual manufacturers under
contract with a description of the
manufacturing being performed
Please include data on the body competent for evaluating the conformity and which issued
the conformity certificate of the sterilisation procedure or the measuring functions of the
medical device

Certificate number

Please indicate if the medical device belongs to the group of medical devices designed for a
special purpose
                        medical devices
                        whose
                        manufacture is
                        commissioned for
                        a certain patient
                        medical
                        device
                        intended for
                        clinical
                        examination
Please indicate if the medical device belongs to the group of medical devices that constitute a
set or a system
                        medical device
                        consisting of
                        several products bearing an
                        EC conformity mark

                        medical device
                        consisting of products
                        some of which do not
                        bear an EC conformity
                        mark


                        medical device which is
                        only sterilised and put
                        into circulation under
                        his/her name by the
                        manufacturer


IV. CATEGORY OF THE MEDICAL DEVICES
The medical devices shall be classified into only one category.
code category of the medical device                                      please indicate
1     active implantable devices
2     anaesthetic and respiratory devices
3     dental devices
4     electrical-mechanical devices
5     technical hospital equipment
6     in vitro diagnostic devices
7      inactive implantable devices
8     ophthalmological optical devices
9     non-disposable instruments
10    non-reusable devices
11    technical devices for the disabled
12    diagnostic and therapeutic radiology devices




V. STATEMENT OF THE PERSON RESPONSIBLE TO THE PERSON SUBMITTING THE
REQUEST

I, the undersigned, hereby confirm that:

   • The information relating to the request for entering AIMD medical devices into the
     Register is reliable and the AIMD medical device conforms to the prescribed
     regulations. I hereby undertake the responsibility to inform the Drug and Medical
     Devices Agency of any alterations regarding the medical device
   • I will monitor any undesirable side-effects and I will inform the Agency in accordance with
     the regulations
   • The submitted documentation is identical to that which has been submitted before
     the competent body in the EU
   • The registered activity is performed with a simultaneous protection of public health in
     accordance with existing regulations
Name, surname and function of the person responsible to the person submitting the
request (as indicated in the Central Registry of the Republic of Macedonia)
Name of the legal entity _______________________________________________
Signature _____________________________date _________________________
Stamp of the legal entity _______________________________________________


Name, surname and function of the person responsible to the person submitting the
request (for monitoring undesirable side-effects)
Name of the legal entity ______________________________________________
Signature _____________________________date ________________________
Stamp of the legal entity _____________________________________________


This template shall not be altered in any way
 STATEMENT OF EVIDENCE OF INSURING THIRD PARTIES AS A
 CONSEQUENCE OF THE USE OF MEDICAL DEVICES


BASIC DATA

Full name of the manufacturer:
headquarters/address
city
telephone
fax
e-mail


Full name of the person submitting the
request:
headquarters/address
city
telephone
fax
e-mail

Subject of insurance

Insurance policy number


Expires on:
Territory for which it is valid             Republic of Macedonia
                                            Europe
                                            worldwide
The person submitting the request shall publish and submit to the Agency any
evidence whose validity is temporally limited


List of enclosed supporting material


                                  Signature and stamp of the responsible person

				
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