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Report №_______________

of the Analytical Expertise of Medical Devices

Including Consumables and Components for Medical Equipment

which are Medical Devices for State Registration, Re-registration and Amendments
1. Information on the accredited testing laboratory

1) name, legal position _____________________________________________________________________________

2) accreditation certificate (number, date, validity) _____________________________________________________________________________

3) post code, legal and actual addresses

____________________________________________________________________________________________

________________________________________________________________________________________________________

4) telephone numbers _________________________________________________________________________________________

5) fax ______________________________________________________________________________________________________________

6) E-mail __________________________________________________________________________________________



2. Information on medical devices


The name of a medical good with size and completed units specified

 

Organization-producer, producer’s country




Batch

 Validity

Production date

Shelf-life

Quantity of samples

 

Application number

 

Date of receipt for analysis

 

Work completion date

 


3. Analytical expertise results

The normative document used for medical devices analysis (specify) ________________________________



Results of medical devices check are presented in the table.
Table


Parameters name

Normative documents requirements

Actual results

 


Conclusion: (conclusions on analysis methods reproduction and conformity (non-conformity) of the samples submitted to quality and safety characteristics specified in the normative document of the organization-producer).

 

Date of conclusion «____» _______ 20____

 

Surname, name, patronymic of the person

in charge of analytical expertise, signature __________

Department (laboratory) head’s surname, name, patronymic, signature _________

Stamp here
Annex 4

to the Procedure of medical devices and

medical equipment expertise

 

Form

 

Expert's Conclusion on Results of Special Expertise

of the Medical Devices and Equipment Submitted

for State Registration, Re-registration in the Republic of Kazakhstan

 

1.

Surname, name, patronymic of the expert

 

2.

Academic degree, title

 

3.

Application number and date

 

4.

Date of documents receipt for special expertise

 

5.

Trade name of medical devices and equipment

 

6.

Technical characteristics of medical devices and equipment

 

7.

Function of medical devices and equipment

 

8.

Application area

 

 

Expertise of the registration dossier documents which characterize medical devices and equipment safety, efficiency and quality has been carried out.

 

  1. Information on the producer of medical devices and equipment including consumables and components which are medical devices

 

No

Type of the organization or production section

Name of the organization

Country

Expert's notes

 

Organization-producer of medical devices and equipment (person in charge of quality and safety)

 

 

 

 

Contract producer

 

 

 

 

Packer

 

 

 

 

Organization-producer (manufacturer) of consumables and components which are medical devices


 

 

 

 

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

 

No

Country

Marketing authorization number

Date of issue

Expert's notes

 

 

 

 

 

 

3. Assessment of accuracy of the medical devices and equipment safety class specified in the application and registration dossier according to the requirements of the legislation of the Republic of Kazakhstan in medical devices and equipment marketing sphere:

 

Safety class specified in the application

Safety class specified in the registration dossier documents

Conformity of the specified safety class to the requirements of the legislation of the RoK

Expert's notes

 

 

 

 

 

4. Parameters system characteristics which determine safety, efficiency and quality of medical devices and equipment including consumables and components which are medical devices:

 

1) quality management system ISO, GMP of organization-producer, including consumables and components which are medical devices:

 

No

Document name

Document number and date of issue

Expiration date

Expert's notes

 

 

 

 

 

 

2) quality of medical devices and equipment, including consumables and components which are medical devices (TS /technical specifications/, organization standard, etc.):

 

No

Document name

Document number and date of issue

Expiration date

Expert's notes

 

 

 

 

 

 

3) confirmation of conformity of medical devices/medical equipment to the normative requirements of national or international normative documents (Conformity Declaration, Conformity Certificate):

 

No

Document name

Document number and date of issue

Expiration date

Expert's notes

 

 

 

 

 

 

4) analysis of the results (reports, conclusions, etc.) obtained during studies (toxicological, technical, clinical, etc.) in the producer’s country and during previous expertise stages performed in the Republic of Kazakhstan (primary expertise, analytical expertise):

 

No

Document name

Analysis of integrity and quality of information in the document

Expert's notes

 

 

 

 

 

5) conclusion on medical devices stability, stated shelf-life feasibility:

 

No

Stated expiration date

Analysis of the presented report on stability

Expert's notes

 

 

 

 

 

6) assessment of medical devices application instruction draft including medical equipment consumables and components which are medical devices, and medical equipment operational document

 

No

Analysis

Expert's assessment

1.

Completeness of for medical devices instruction draft

 

2.

Conformity of draft text to the producer's original instruction

 

3.

Conformity of instruction draft execution to the requirements of the legislation of the Republic of Kazakhstan in the medicinal products marketing sphere

 

4.

Information contained in the operational document on medical equipment application

 

 

7) Assessment of package and label designs

 

No

Analysis

Expert's assessment

1.

Conformity of labeling design text execution to the requirements of the legislation of the Republic of Kazakhstan in medicinal products, medical devices and equipment marketing sphere

 

 

Identity of storage and transportation conditions specified in the medical devices standardization document and in the medical application instruction draft

 

 

4. Expert's conclusion

 

No

Recommendations

 

1.

To recommend the medical devices and equipment for state registration, re-registration (with registration, re-registration period specified)

 

2.

To examine documents again after submission of additional materials upon request

 

3.

Not to recommend medical devices/medical equipment for registration, re-registration (with rejection arguments specified)

 

 

I hereby certify that all the data in the expert’s conclusion is accurate and meets the standard requirements which is confirmed by my own signature.

Expert's surname, name, patronymic Signature ___________________

 

Expertise completion date        «____» ______ 20___

 
Annex 5

to the Procedure of medical devices and

medical equipment expertise

 

Form

 

The Conclusion of Expert of Medical Devices and Equipment

Special Expertise on Influence of the Stated Type 1 amendments,

not Requiring New Registration, to the Registration Dossier

on Medical Devices/Medical Equipment Safety, Efficiency and Quality

 

1.

Expert’s surname, name, patronymic

 

2.

Academic degree, title

 

3.

Application number and date

 

4.

Date of documents receipt for special expertise

 

5.

Trade name of medical devices and equipment

 

 

The expertise of the registration dossier documents which characterize influence on safety, efficiency and quality of Type I amendments, not requiring new registration, to the registration dossier, on medical devices and equipment has been carried out.

 

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

 

No

Edition (before introduction of amendments)

Amendment

 

 

 

 

Influence of amendments on medical devices and equipment safety, efficiency and quality:

 



Amendments

(mark the item that applies)

Analysis

(influences/does not influence) In case of negative conclusion, reasons are specified

 

1. Production license content change:

- change of the factory-producer (manufacturer) name;

distributor name

- change of production site for the entire manufacturing process or its part

 

 

2. Change of medical devices/medical equipment names

 

 

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

 

 

4. Removal/addition of therapeutic indications, application area, counterindications, adverse effects

 

 

5.Change of organizations-producers (manufacturers) of medical devices designed for packing, processing, final packaging, and labeling of accessories and (or) components and (or) consumables and (or) change of production site by the organization-producer (manufacturer) of medical devices designed for packing, processing, final packaging, and labeling of medical accessories and (or) components and (or) consumables.

 

 

6. Increase/decrease of medical devices shelf-life

 

 

7. Storage conditions change

 

 

8. Changes in the procedure of end medical product quality control

 

 

9. Change of the medical devices package:

 - immediate packaging of the medical devices:

 - secondary and (or) group packaging

 

 

10. Change of imprints, base coatings or other marks, stamps and inscriptions including addition or change of paint used for labeling.

 

 

Expert's conclusion

 



Recommendations

Expert's notes

1.

To recommend Type I amendments to the registration dossier not requiring new registration of medical devices/medical equipment for the remaining period of the marketing authorization validity

 

2.

To examine documents again after submission of additional materials upon request

 

3.

Amendments influence negatively on medical devices/medical equipment safety, efficiency and quality (with rejection arguments)

 

4.

Amendments introduced into the medical devices/medical equipment registration dossier should be referred to Type II (new registration)

 

 

I hereby certify that all the data in the expert’s conclusion is accurate and meets the standard requirements which is confirmed by my own signature.

Expert's surname, name, patronymic Signature ___________________

 

Expertise completion date        «____» ______ 20___
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