Article 63 and 71




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in medicinal products, medical devices and equipment distribution chain (hereinafter referred to as governmental body):

1) conclusions of the governmental body on performance of the expertise of medical devices and equipment submitted for registration, re-registration and amendments to the registration dossier;

2) the registration dossier with record statement of documents content;

3) samples of medical devices (including medicinal consumables and components) sufficient for three-stage analysis;

4) standard samples (with the application specified in the normative document) of:

material which is used for medical devices production;

medicinal products which are contained in the medical drugs;

control materials for diagnostic test-systems and reagents;

impurities;

including consumables and components for medical devices and equipment, which are medical devices.

5) document which confirms the payment of the expertise fee.

5. The applicant pays for the expertise of medical devices and equipment during registration, re-registration and amendments to the registration dossier by transfer to the account of the expert organization, full payment is made in advance. 

 

2. Procedure of the Expertise of Medical Devices and Equipment

and Amendments to the of the Registration Dossier

 

6. The expertise of registration, re-registration and Type II amendments to the registration dossier, regulated by the Procedure of state registration, re-registration and amendments to the registration dossier of medicinal products, medical devices and equipment which are approved by the order No735 of the Minister of Public Health of the Republic of Kazakhstan of November 18, 2009 (registered in the Register of state registration of normative legal acts under No5935), (hereinafter referred to as Procedure of state registration), consists of 3 stages:

primary expertise:

analytical expertise;

special expertise of medical devices and equipment (hereinafter referred to as special expertise).

During expertise of medical devices containing medicinal product, the expert organization's department performs additional pharmaceutical expertise of quality and safety of medicinal products, medical devices and equipment for registration, re-registration and amendments to the registration dossier.

The expertise of medical devices and equipment during introduction of Type I amendments regulated by the Procedure of state registration consists of:

primary expertise;

special expertise.

7. The medicinal product which forms part of medical devices and equipment and is their constituent is subject to expertise in the order of medicinal products.

8. Each successive stage of expertise is carried out on basis of the positive conclusion of the previous one.

9. When performing expertise the expert organization has the right to request the applicant’s explanation and (or) specifications of the documents submitted in the registration dossier.



10. If within 30 calendar days the Applicant does not present materials requested or written grounding of the terms necessary for preparation of these materials (but not more than 60 calendar days) the expert organization terminates the expertise and informs the governmental body and the applicant about the decision within 10 calendar days from the date of making the decision.

Suspension of period which is necessary for preparation of materials requested should not exceed 30 calendar days.

11. The expert organization presents to the departmental record office the following documents: a copy of medical devices and equipment registration dossier with a copy of the marketing authorization, the conclusion of primary, special and pharmaceutical (if necessary) expertises, report of analytical expertise of the medical devices, approved application instruction of medical devices, approved package and label designs for medical devices, materials on correspondence with the Applicant.



 

 

3. Procedure of Primary Expertise of Medical Devices and Equipment



and Amendments to the Registration Dossier

 

12. Primary expertise of medical devices and equipment includes:

evaluation of completeness of the registration dossier, correctness of execution of the documents submitted;

setting of conformity of the stated medical devices and equipment safety class to the class specified in the registration dossier;

setting of conformity of execution of medical products application instruction draft to the requirements of the legislation of the Republic of Kazakhstan regarding medicinal products, medical devices and equipment marketing sphere;

check of conformity of Types I and II amendments stated in the registration dossier according to the Procedure of state registration;

control of existence of medical devices samples and their sufficiency for three-stage analysis of analytical expertise and their shelf-life;

check of standard samples existence (in case if their application is specified in the normative document) for:

material of the medical devices production;

medicinal product contained in the medical devices

control materials for diagnostic test-systems and reagents;

impurities;

including consumables and components of medical equipment and devices which are medical devices themselves;

13. According to results of primary expertise expert’s conclusion is performed in the form according to Annexes 1, 2 to the present Procedure, one copy of which is given to the applicant.



  

4. Procedure of Analytical Expertise



of Medical Devices Including Consumables and

Components of Medical Equipment which are Medical Devices

 

14. Analytical expertise of medical devices including consumables and components of medical equipment which are medical devices includes:

1) physical, chemical, biological tests of medical devices samples according to the requirements of the normative document;

2) assessment of normative document quality with regard to testing methods reproducibility.

15. The testing laboratory draws up report on the analytical expertise of medical devices, including consumables and components of medical equipment which are medical devices, in the form according to Annex 3 to the present Procedure.  



 

5. Procedure of Special Expertise



of Medical Devices and Equipment

 

16. Special expertise consists of:

1) assessment of medical devices and equipment safety, efficiency and quality;

2) assessment of influence of registration dossier amendments on medical devices and equipment safety, efficiency and quality;

3) assessment of reliability of the data stated in the application and documents of the registration dossier regarding safety class of medical devices and equipment according to the requirements of the legislation of the Republic of Kazakhstan in medicinal products, medical devices and equipment distribution chain;

4) analysis of the testing laboratory report, assessment of results of the analytical expertise;

5) analysis of the clinical testing report on application of medical devices and equipment of 2ndb safety class (increased risk degree) and of 3rd safety class (high risk degree) in clinical practice;

6) analysis of conformity of the draft of medical devices application instruction to the original instruction of the organization-producer and conformity of instruction draft execution to the requirements of the legislation of the Republic of Kazakhstan in the medicinal products, medical devices and equipment distribution chain;

7) analysis of information specified on package and label designs according to the requirements of the legislation of the Republic of Kazakhstan in the sphere of medicinal products, medical devices and equipment distribution chain;

8) assessment of information of the medical equipment operational document;

9) analysis of stability of medical devices and (or) medicinal product in the composition of the medical devices stated in the registration dossier;

10) expertise of conformity of quality parameters, stated in the normative document of the organization-producer, to international standards of quality.

17. According to results of special expertise expert’s conclusion is performed in the form according to the Annexes 4, 5 to the present Procedure.



 

6. Conclusion on Medical Devices and Equipment Safety, Efficiency and Quality



 

18. The expert organization prepares conclusion on medical devices and equipment safety, efficiency and quality based on results of primary, analytical, special and, if necessary, pharmaceutical expertises.

19. Conclusion on medical devices and equipment safety, efficiency and quality is presented to the governmental body for decision making on medical devices and equipment state registration, re-registration and amendments to the registration dossier or rejection thereof.



 

 

7. Period of Medical Devices and Equipment Expertise Performance



and Amendments to the Registration Dossier

 

20. Medical devices and equipment expertise is performed within the following period:

1) state registration and re-registration of medical devices and equipment of 1st safety class (low risk degree) and 2nda safety class (medium risk degree) – three calendar months; medical devices containing medicinal product – four calendar months, including:

primary expertise – fifteen calendar days;

analytical expertise – thirty calendar days;

special expertise – twenty five calendar days, medical devices containing medicinal product – fifty-five calendar days;

conclusion execution – twenty calendar days;

2) state registration of medical devices and equipment of 2ndb safety class (increased risk degree) and 3rd safety class (high risk degree) – six calendar months, including medical devices containing medicinal product:

primary expertise – twenty calendar days;

analytical expertise – sixty calendar days;

special expertise – eighty calendar days, including medical devices containing medicinal product;

conclusion execution – twenty calendar days;

3) re-registration of medical devices and equipment of 2ndb safety class (increased risk degree) and 3rd safety class (high risk degree) - four calendar months, including medical devices containing medicinal product:

primary expertise – twenty calendar days;

analytical expertise – fifty calendar days;

special expertise – thirty calendar days, including medical devices containing medicinal product;

execution of conclusion – twenty calendar days;

4) expedited procedure of state registration of medical devices and equipment:

primary expertise – ten calendar days;

analytical expertise – thirty calendar days;

special expertise – twenty calendar days;

execution of final documents– five calendar days;

5) introduction of Type I amendments into the medical devices and equipment registration dossier – two calendar months including:

primary expertise – fifteen calendar days;

special expertise – thirty calendar days;

execution of conclusion – fifteen calendar days;

21. Medical devices and equipment expertise performance period does not include the period for addition of missing documents to the registration dossier, submission by the Applicant of requested documents and materials at any expertise stage as well as the period of clinical and other studies.



In case if incomplete package of documents and materials for the expedited state registration of medical devices and equipment is submitted, registration is performed within the period specified by subclauses 1) and 2) of Clause 20 of the present Procedure.
 

Annex 1

to the Procedure of medical devices and

medical equipment expertise

 

 

Form

 

Primary Expertise Conclusion for Documents and Materials of Medical Devices/Medical Equipment Submitted for State Registration, Re-registration in the Republic of Kazakhstan

 

1.

Expert’s surname, name, patronymic (primary expertise specialist)

 

2.

Application number and date

 

3.

Date of receipt of the documents for primary expertise

 

4.

Trade name of medical devices, medical equipment

 

5.

Application of the medical devices/medical equipment

 

6.

Application area

 

7.

Safety class

 

8.

Patent protection in the Republic of Kazakhstan (with document number, date of issue, issuing body specified)

 

9.

Trade mark protection in the Republic of Kazakhstan (with document number, date of issue specified)

 

10.

Firm-applicant

 


Primary expertise of application documents and materials for medical devices/medical equipment submitted for state registration, re-registration in the Republic of Kazakhstan has been carried out.

As a result of the expertise the following has been found out:

 

1. Assessment of the registration dossier completeness and execution correctness of submitted documents

 

No

Document name

Existence note

Expert’s note on compliance to execution requirements

1.

Application

 

 

2.

A letter of authority from the producer for the right to present interests upon state registration, re-registration in the Republic of Kazakhstan

 

 

3.

Information on the producer (manufacturer): name, activity type, legal address, form of ownership, administrative authorities, a list of departments and subsidiaries with their status and powers specified

 

 

4.

Document certifying registration of the medical devices/medical equipment in the producer’s country and/or free sale certificate (Free Sale)

 

 

5.

Document which confirms compliance of production conditions to national and/or international standards (GMP; ISO; EN)

 

 

6.

The marketing authorization of the Republic of Kazakhstan for the medicinal product which forms part of the medical devices

 

 

7.

Document certifying compliance of the medical devices/medical equipment to the requirements of national or international normative documents (Conformity declaration, Conformity certificate)

 

 

8.

Report (protocol) on toxicological and hygienical tests of the medical devices including consumables for medical devices/medical equipment which are medical devices

 

 

9.

Report on technical tests of the medical devices including consumables for medical devices/medical equipment which are medical devices

 

 

10.

Report on stability study (with shelf-life specified) of the medical devices including consumables for medical devices/medical equipment which are medical devices

 

 

11.

Report on pre-clinical (non-clinical) tests (only for medical devices)

 

 

12.

Report on technical tests (for medical equipment)

 

 

13.

Results of clinical (medical) tests (application)

 

 

14.

Normative document which medical devices/medical equipment must conform to: international standard, national standard, organization standard, technical conditions

 

 

15.

Specification with technical characteristics, a list of components and consumables (according to the form)

 

 

16.

Medical equipment operational document in Russian

 

 

17.

Application instruction for medical devices (original document from the producer (manufacturer), including consumables for medical devices/medical equipment which are medical devices

 

 

18.

Application instruction draft for medical devices in the national and Russian languages (in hard and soft copy), including consumables for medical devices/medical equipment which are medical devices

 

 

19.

Samples of medical devices, including consumables for medical devices/medical equipment which are medical devices

 

 

20.

Standard samples (when their application is specified in the normative document) for: - production material of medical devices; - medicinal product contained in medical devices; - control materials for diagnostic test-systems and reagents; -foreign substances, including consumables and components for medical devices/medical equipment which are medical devices

 

 

21.

Documents regulating packaging materials quality (for immediate packaging) (only for medical devices, including consumables for medical devices/medical equipment which are medical devices)

 

 

22.

Not less than 13 х 18 сm coloured photos (they must show the appearance of the medical devices, components, consumables)

 

 

23.

Coloured package and label designs (only for medical devices, including consumables for medical devices/medical equipment which are medical devices)

 

 

24.

A graphic image of the medical equipment label

 

 

25.

Labeling design text in the national and Russian languages

 

 

26.

A copy of the marketing authorization of the Republic of Kazakhstan upon re-registration

 

 


2. Registration in the producer’s country (manufacturer’s) and other countries

 

No

Country

Document number which certifies registration

Date of issue

Expert’s note

 

 

 

 

 


3. Conformity of medical devices and equipment safety class stated in the application and the registration dossier documents:

 

No

Safety class in accordance with the application

Safety class in accordance with the registration dossier documents

Name of the registration dossier document specifying safety class

Expert’s note

 

 

 

 

 

 

4. Conformity of submitted samples of medical devices, including consumables for medical devices/medical equipment which are medical devices to analytical expertise requirements:


Name of samples (with volume, sizes, etc. specified)

Batch

Quantity of submitted standard samples (in measurement units: bottles, pieces, packages, etc.)

Shelf-life

Remaining shelf-life of products samples

Storage (transportation) conditions

Package (type)

 

 

 

 

 

 

 


5. Conformity of submitted standard samples (when specifying their application in the normative document) for:

- production material of medical devices;

- medicinal product contained in the medical devices;

- control materials for diagnostic test-systems and reagents;

- foreign substances;

including consumables and components for medical devices and equipment which are medical devices:

 

Name of standard samples

Quantity of submitted standard samples (in measurement units: bottles, pieces, packages, etc.)

Shelf-life

Remaining shelf-life of products samples

Storage (transportation) condition

Package (type)

 

 

 

 

 

 

 

6. Expert’s conclusion:

1) positive expertise conclusion text:

«Materials and documents of the registration dossier, submitted by the Applicant for state registration, re-registration of medical devices and equipment in the Republic of Kazakhstan, meet the requirements and are subject to further expertise »;

 2) negative expertise conclusion text:

 «Primary expertise of the registration dossier materials and documents, submitted by the Applicant for state registration, re-registration of medical devices and equipment in the Republic of Kazakhstan, has shown that the registration dossier does not meet the requirements regarding:

No

Non-compliances:

Expert’s note

 

 

 

 

You are requested to submit missing documents and materials within the period not exceeding 30 calendar days.

The expert works are terminated and will be resumed after the missing documents, materials and corrections are submitted.

In case if the missing documents are not presented and comments are not resolved in the above mentioned time period, the name of the medical devices and equipment submitted by You will be recommended for rejection of state registration, re-registration».

 

Date of issue of the expert’s conclusion:

«____» ______ 20___

 

 

Expert’s surname, name, patronymic Signature ____________

Department head’s surname, name, patronymic Signature ____________

General director deputy’s surname, name, patronymic Signature ____________
Expertise results familiarization date:
«____» ______ 20___

Applicant’s surname, name, patronymic Signature ___________

 

Primary expertise comments are resolved:

completely _______ date «____» ______ 20___

partially _________ date «____» ______ 20___.

 

 

Expert’s surname, name, patronymic _____________ Signature ____________
It is recommended to reject (in case if comments have not been resolved)

date «____» ______ 20___

 

Expert’s surname, name, patronymic _____________ Signature ____________

 

Annex 2

to the Procedure of medical devices and

medical equipment expertise

 

 

Form

 

Primary Expertise Conclusion for Documents and Materials of Medical Devices/Medical Equipment Submitted for Type I Amendments, which do not Require New State Registration during the Validity Period of the Marketing Authorization in the Republic of Kazakhstan


1.

Expert’s surname, name, patronymic (primary expertise specialist)

 

2.

Application number and date

 

3.

Date of receipt of the documents for primary expertise

 

4.

Trade name of the medical devices/medical equipment according to the valid marketing authorization

 

5.

Firm-applicant

 

6.

Amendments

 


Primary expertise of the registration dossier and materials of medical devices/medical equipment submitted for Type I amendments, not requiring new state registration during the validity period of the marketing authorization in the Republic of Kazakhstan has been carried out.
As a result of the expertise the following has been found out:
1. Assessment of the registration dossier completeness and submitted documents execution correctness according to the approved list of documents for amendments

 

No

Document name

Existence note

Expert’s note on compliance to execution requirements

1.

Change of the production license content: change of the name of the manufacturer; distributor, change of production place (places) of the production process

Application for amendments according to the approved form;

 

 

A letter of authority from the producer (manufacturer) for the right to present interests upon state registration in the Republic of Kazakhstan;

 

 

Document certifying registration of the medical equipment in the producer’s (manufacturer’s) country and/or free sale certificate (Free Sale) with amendments introduced;

 

 

*State license for the production right in the producer’s (manufacturer’s) country;

 

 

*annex(attachment) to the license with a list of basic component parts, materials;

 

 

Document which confirms compliance of production conditions to national and/or international standards (GMP; ISO; EN);

 

 

Document which confirms conformity of medical equipment to national or international normative documents (Conformity declaration; Conformity certificate);

 

 

A copy of the marketing authorization of the Republic of Kazakhstan;

 

 

Producer’s (manufacturer’s) letter certifying that the production process and finished product quality and safety control remain unchanged, with the date of amendments specified;

 

 

Medical devices application instruction drafts;

 

 

Labeling design

 

 

2.

Change of medical devices and/or medical equipment name

Application for amendments according to the approved form;

 

 

A letter of authority from the producer (manufacturer) for the right to present interests upon state registration in the Republic of Kazakhstan;

 

 

Document certifying registration of the medical equipment in the producer’s (manufacturer’s) country and/or free sale certificate (Free Sale);

 

 

A copy of the marketing authorization of the Republic of Kazakhstan

 

 

Producer’s (manufacturer’s) letter containing motivated arguments for the necessity to change the name of the medical devices/medical equipment ;

 

 

Medical devices application instruction drafts; labeling design

 

 

3.

Change of (increase/decrease of parts and/or replacement) accessories and/or components and/or consumables

Application for amendments according to the approved form;

 

 

A copy of the marketing authorization of the Republic of Kazakhstan

 

 

Producer’s (manufacturer’s) letter containing motivated agruments for the necessity to change components and specifying a new list of components;

 

 

Medical equipments operational document

 

 

4.

Removal/addition of therapeutic indications; application area; adverse effects

Application for amendments according to the approved form;

 

 

A copy of the marketing authorization of the Republic of Kazakhstan

 

 

Producer’s (manufacturer’s) letter containing motivated arguments for the necessity to change therapeutic indications;

 

 

Medical devices application instruction drafts;

 

 

formerly approved instruction;

 

 

labeling design (if necessary);

 

 

results of clinical (medical) tests which reflect the amendments introduced

 

 

5.

Change of producers of devices, accessories and/or components and/or consumables for packing, processing, final packaging and labeling.

Application for amendments according to the approved form; finished product safety remains unchanged; medical devices application instruction drafts (if necessary)

 

 

6.

Increase/decrease of medical devices shelf-life

Application for amendments according to the approved form;

 

 

A copy of the marketing authorization of the Republic of Kazakhstan

 

 

Producer’s (manufacturer’s) letter certifying that the production process and finished product quality and safety control remain unchanged;

 

 

Stability data for medical devices (no less than for 3 batches);

 

 

Medical devices application instruction draft (if necessary);

 

 

Labeling design

 

 

7.

Storage conditions change

Application for amendments according to the approved form;

 

 

A copy of the marketing authorization of the Republic of Kazakhstan;

 

 

Producer’s (manufacturer’s) letter grounding storage condition change;

 

 

Stability data for medical devices (no less than for 3 batches);

 

 

Medical devices application instruction draft (if necessary);

 

 

Labeling design

 

 

8.

Change of the finished medical product quality control procedure

Application for amendments according to the approved form;

 

 

A copy of the marketing authorization of the Republic of Kazakhstan;

 

 

Producer’s (manufacturer’s) letter certifying that the production process remains unchanged;

 

 

Producer’s letter, certifying that the control procedure does not level down the quality and safety of the finished product;

 

 

normative technical documents with amendments which regulate finished product quality

 

 

9.

Change of the medical devices package: primary packaging of medical devices; secondary and/or group packaging

Application for amendments according to the approved form;

 

 

A copy of the marketing authorization of the Republic of Kazakhstan;

 

 

Producer’s letter (manufacturer’s), certifying that amendments introduced regarding immediate packaging influence/do not influence on stability, quality of medical devices;

 

 

standard technical documents with amendments;

 

 

package design of new and former samples;

 

 

labeling design of new and former samples;

 

 

not less than13 x 15 cm sized photo of the medical equipment

 

 

10.

Change of prints, base coats or other marks, stamps and inscriptions including addition or change of paint used for labeling

Application for amendments according to the approved form;

 

 

A copy of the marketing authorization of the Republic of Kazakhstan;

 

 

Producer’s (manufacturer’s) grounding letter on amendments;

 

 

package design;

 

 

labeling design;

 

 

not less than13 x 15 cm sized photo of the medical equipment

 

 


6. Expert’s conclusion:

1) positive expertise conclusion text:

«Materials and documents of the registration dossier, submitted by the Applicant for Type I amendments not requiring new state registration of medical devices/medical equipment in the Republic of Kazakhstan during the marketing authorization validity period in the Republic of Kazakhstan, meet the requirements and are subject to further expertise »;

 

2) negative expertise conclusion text:

 

«Primary expertise of the registration dossier materials and documents, submitted by the Applicant for Type I amendments not requiring new state registration of medical devices/medical equipment in the Republic of Kazakhstan during the marketing authorization validity period in the Republic of Kazakhstan, has shown that amendments to the registration dossier do not meet the requirements regarding:

No

Non-compliances

Expert’s note

 

 

 

 

You are requested to submit missing documents and materials within the period not exceeding thirty calendar days. Expert works are terminated and will be resumed after the missing documents, materials, corrections are submitted.
In case if the missing documents are not presented and comments are not resolved, the name of the medical good/medical equipment submitted by You will be recommended to rejection to Type I amendments not requiring new state registration during the validity period of the marketing authorization in the Republic of Kazakhstan».

 

Date of issue of expert conclusion:

 

«____» ______ 20___

 

 

Expert’s surname, name, patronymic Signature ____________

Department head’s surname, name, patronymic Signature ____________

General director deputy’s surname, name, patronymic Signature ____________
Expertise results familiarization date:

 

«____» ______ 20___

 

 

Applicant’s surname, name, patronymic Signature ____________

 

Primary expertise comments are resolved:

 

completely _______ date «____» ______ 20___

partially ________ date «____» ______ 20___

 

 

Expert’s surname, name, patronymic _____________ Signature ____________

 

It is recommended to reject (in case if comments have not been resolved)

 

date «____» ______ 20___

 

 

Expert’s surname, name, patronymic _____________ Signature ____________

 

Annex 3

to the Procedure of medical devices and

medical equipment expertise

 

 

Form

 
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