of May 16, 2016 No. 38
About approval of Rules of carrying out researches (testing) for the purpose of assessment of biological effect of medical products
According to article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, items 4 and the 5th article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014, Items 105 and 106 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, and for the purpose of execution of the Decision of the Supreme Eurasian economic council of December 23, 2014 "About implementation of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union" Council of the Eurasian economic commission DECIDED: No. 109
1. Approve the enclosed Rules of carrying out researches (testing) for the purpose of assessment of biological effect of medical products.
2. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.
|
Members of council of the Eurasian economic commission: From the Republic of Armenia |
V. Gabriyelyan |
|
From the Republic of Belarus |
V. Matyushevsky |
|
From the Republic of Kazakhstan |
B. Sagintayev |
|
From the Kyrgyz Republic |
O. Pankratov |
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From the Russian Federation |
I. Shuvalov |
Approved by the Decision of Council of the Eurasian economic commission of May 16, 2016 No. 38
1. These rules establish within the Eurasian Economic Union (further - the Union) procedure for carrying out researches (testing) for the purpose of assessment of biological effect of medical products for registration (further - researches (testing)), including requirements to the authorized organizations having the right to conduct researches (testing) (further - authorized organizations).
2. For the purposes of these rules concepts which mean the following are used:
"category of medical product" - the classification sign of medical product determined in case of the choice of evaluation methods of biological effect of medical product depending on group, type and duration of contact of medical product;
"material" - synthetic or natural polymer, metal, alloy, ceramics or other impractical material, including the impractical biological fabric (which does not have the potential for metabolism or reproduction), applied as medical product or its part;
"sample of medical product" - the product or its representative part which are directly subjected to research (testing);
"standard sample of medical product" - the sample chosen from group of the medical products belonging to one category, made by one producer according to single technical documentation and having identical structure (material), area and conditions of application. At the same time selection of standard samples on structure of medical products shall reflect all set of group of homogeneous medical products taking into account distinctions in properties of medical products of separate models (brands) in this group.
Other concepts used in these rules are applied in the values determined by acts of bodies of the Union in the field of the address of medical products.
3. Researches (testing) are conducted for the purpose of establishment of compliance of medical product to General requirements of safety and efficiency of medical products, to requirements to their marking and the operational documentation on them approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 27 (further - General requirements).
4. When carrying out researches (testing) requirements of the standards included in the list of standards as a result of which application on voluntary basis observance of compliance of medical products to General requirements, and also methods (techniques) of researches (testing) certified (validirovanny) and approved according to the legislation of state member of the Union is fully or partially provided (further - state member) are applied.
5. Researches (testing) are conducted in the test laboratories (centers) chosen as the applicant, data on which are included in the unified register of the authorized organizations having the right to conduct researches (testing) of medical products for the purpose of their registration (further - the register of authorized organizations).
Forming and maintaining the register of authorized organizations are performed by the Eurasian economic commission (further - the Commission) according to the Procedure for forming and maintaining information system in the field of the address of medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 30, on the basis of the data represented by the public authorities of state members authorized on implementation and (or) coordination of activities in the field of the address of medical products (further - authorized bodies), with use of means of the integrated information system of the Union.
6. Researches (testing) are conducted concerning medical products and (or) accessories to them, directly or indirectly contacting to the surface of body of the person, his mucous membranes, internal circles of organism for which the specified interaction (contact) is necessary for accomplishment of their function.
7. Results of researches (testing) are considered negative if the provided samples (sample) of medical product do not conform to safety requirements.
8. Authorized organization which conducts researches (testing), and also specialists of this organization conducting researches (testing) cannot be with the producer of medical product, his authorized representative or other persons interested in results of researches (testing) in the relations influencing their impartiality.
The commercial, financial or other pressure putting impartiality of the authorized organization conducting researches (testing) under threat is not allowed.
9. Researches (testing) include:
a) determination of sanitary and chemical indicators;
b) assessment of biological effect in the conditions of i№vitro and i№vivo. Types of biological effect proceeding from category of medical product are subject to assessment;
c) microbiological researches (testing).
10. For carrying out researches (testing) the applicant submits the application containing the following information to authorized organization:
a) name of medical product;
b) the name of the applicant, its location (the address of the legal entity) - for the legal entity or surname, name, middle name (in the presence), the residence - for the physical person registered as the individual entrepreneur, data on state registration of the legal entity or physical person as the individual entrepreneur and also contact information of the applicant (phone number, the e-mail address);
c) the name of the producer, its location (the address of the legal entity) - for the legal entity or surname, name, middle name (in the presence), the residence - for the physical person registered as the individual entrepreneur;
d) data on the production site (production sites) - the name of the legal entity or surname, name, middle name (in the presence) the physical person registered as the individual entrepreneur and also the address of the place of implementation of activities;
e) identification signs of sample of medical product (brand, model, weight, amount, date of production (production), expiration date (service life), catalog number, serial (serial) number (number of series, batch (lot)), etc. (when applicable));
e) the class of potential risk of application of medical product determined according to the Rules of classification of medical products depending on potential risk of application approved by the Decision of Board of the Eurasian economic commission of December 22, 2015 No. 173;
g) appointment and scope of medical product.
11. The following documents are attached to the request:
operational documentation and technical documentation (the technical file) on medical product, including the working drawings, tables and schemes necessary for carrying out researches (testing). Requirements to contents of the technical file on medical product are established by appendix No. 3 to the Rules of carrying out clinical and clinical laboratory testing (researches) of medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 29, on medical product for diagnostics of in vitro - appendix No. 5 to the Requirements to implementation, maintenance and assessment of quality management system of medical products depending on potential risk of their application approved by the Decision of Council of the Eurasian economic commission of November 10, 2017 No. 106;
the documents containing data on marking and packaging of medical product (full-color prototypes of packagings and labels);
the list of standards to which there corresponds the medical product, and also methods (techniques) of researches (testing) certified (validirovanny) and approved according to the legislation of state member;
copies of protocols of researches (testing) of medical product and (or) materials of which the medical product and (or) belongings to it which are carried out in other authorized organizations and confirming compliance of medical product to General requirements and (or) protocols of own researches (testing) of medical product are made (in the presence);
the documents containing data on medicines as a part of medical product, their structure, quantity on compatibility of medicine with medical product (in the presence as a part of medical product of medicines);
the documents containing data on materials (including about structure, brands and producers of materials, availability of disinfectants, biologically active agents, biocellular products, nanomaterials) of which medical product and (or) belongings to it, and also documents confirming their compliance to the declared characteristics are made;
other documents confirming compliance of medical product to General requirements (in the presence).
If documents are constituted in foreign language, translation into Russian certified according to the procedure, established by the legislation of state member in the territory of which researches (testing) are conducted is applied to them.
12. The authorized organization within 10 working days from the date of the application specified in Item 10 of these rules carries out the analysis of this request and the documents attached to it and makes the decision on possibility (impossibility) of carrying out researches (testing).
13. In case of decision making about possibility of carrying out researches (testing) the authorized organization signs the relevant contract with the applicant.
14. In case of decision making about impossibility of carrying out researches (testing) the authorized organization notifies in writing the applicant on refusal in carrying out researches (testing) (with indication of the reasons), and also returns to the applicant the originals of documents attached to the request.
15. During researches (testing) the authorized organization cooperates with the applicant in connection with the performed work.
16. In case of the conclusion of the contract for carrying out researches (testing):
a) the category of medical product is determined;
b) the research program (testing) is developed by authorized organization together with the applicant;
c) it will be approved with the applicant and the research program (testing) affirms the head of authorized organization.
17. Researches (testing) are conducted on the samples of medical product provided by the applicant according to the research program (testing).
Sampling of medical product for carrying out researches (testing) is performed according to the rules determined by standards or certified (validirovanny) methods (techniques) of researches (testing).
18. Sampling of medical product is performed by the applicant or according to its order authorized organization in the presence of the applicant.
If sampling of medical product is performed by the applicant, results of selection are drawn up by the delivery-acceptance certificate of samples of medical product.
If sampling of medical product is performed by authorized organization for the order of the applicant, results of selection are drawn up by the sampling report of medical product.
19. At all stages of storage, transportation and preparation for researches (testing) of the selected samples of medical product the requirements established in operational documents on medical product shall be observed.
20. In the presence of group of the homogeneous medical products specified in the research program (testing) carrying out researches (testing) on standard samples of medical products is allowed.
In case of carrying out researches (testing) on standard samples in the protocol of researches (testing) the corresponding entry is made.
21. Researches (testing) include the following stages:
a) the analysis of the documents specified in Item 11 of these rules;
b) adjustment of the research program (testing) (if necessary);
c) receipt of standard samples (if necessary);
d) selection or receipt of samples of medical product and their identification on the basis of the data provided by the applicant;
e) carrying out researches (testing) of medical product provided by the research program (testing);
e) registration and issue to the applicant of the protocol of researches (testing) in form according to appendix and the research program (testing).
22. Researches (testing) are conducted by authorized organization within 30 working days from receipt date of samples of medical products in authorized organization according to the research program (testing) in case of payment term by the applicant of the works performed by authorized organization according to the signed agreement. The term of carrying out researches (testing) can be prolonged in cases when more long term is provided by method (technique) of researches (testing).
23. Results of each research (testing) or series of researches (testing) conducted by authorized organization shall be formulated precisely, accurately, unambiguously and objectively.
24. Data on methods (techniques) of researches (testing) for each determined indicator with indication of details of the relevant documents (for methods (techniques) of researches (testing) described in standards the corresponding Items of standards are specified) are provided in the protocol of researches (testing).
25. The documents concerning carrying out researches (testing) are stored by authorized organization in the systematized type during the term established by the legislation of state member.
26. Inclusion of test laboratory (center) in the register of authorized organizations is performed in case of its compliance to the following criteria:
a) availability of registration of test laboratory (center) or organization which part the test laboratory (center), as the legal entity in the territory of state member according to its legislation is;
b) availability of the operating accreditation of test laboratory (center) in national accreditation system of state member;
c) availability in the field of accreditation of test laboratory (center) of medical products and (or) groups of homogeneous medical products, and also types and methods of researches (testing);
d) availability of quality management system and observance by test laboratory (center) of the requirements of quality management system established in the quality manual of test laboratory (center);
e) availability of regulatory legal acts, documents in the field of standardization, rules and methods (techniques) of researches (testing) and measurements, including rules of sampling (tests), and other documents in the field of accreditation of test laboratory (center), and also observance of requirements of these documents by test laboratory (center);
e) availability at the specialist (specialists) of test laboratory (center) which is directly performing works on researches (testing):
the higher education, either secondary professional education, or additional professional education on the profile corresponding to area of accreditation;
work experience, connected with researches (testing), measurements in the field of the accreditation specified in the register of accredited persons, at least 2 years.
27. The test laboratory (center) submits to authorized body the application about inclusion in the register of authorized organizations.
The documents confirming compliance of test laboratory (center) to the criteria specified in Item 26 of these rules are attached to the request.
In the request information on medical products and (or) homogeneous groups of medical products, and also on types and methods of researches (testing) which are included in the area of its accreditation and concerning which the test laboratory (center) submits the application is specified.
28. The authorized body within 10 working days from the date of receipt from test laboratory (center) of the request about inclusion in the register of authorized organizations considers the specified request and reports to test laboratory (center) about the made decision in writing by transfer of the notification personally under list to her representative, or directs it the registered mail with the assurance of receipt, or transfers it in electronic form on telecommunication channels or in electronic form, signed by the digital signature.
29. In case of adoption by authorized body of the decision on inclusion of test laboratory (center) in the register of authorized organizations of the data on test laboratory (center) go to the Commission with use of means of the integrated information system of the Union for entering into the register of authorized organizations, and also can be posted on the official site of authorized body on the Internet.
30. In case of discrepancy of test laboratory (center) to one of the criteria specified in Item 26 of these rules and decision making about refusal in inclusion of test laboratory (center) in the register of authorized organizations the authorized body notifies test laboratory (center) on causes of failure in writing by transfer of the notification personally under list to her representative, or directs it the registered mail with the assurance of receipt, or transfers it in electronic form on telecommunication channels or in electronic form, signed by the digital signature.
31. Appeal of the decision of authorized body is performed according to the legislation of state member.
32. Storage, systematization and change of information on authorized organizations, and also protection against unauthorized access to it are provided with authorized bodies.
33. The register of authorized organizations is published on information portal of the Union.
34. In case of change of the data containing in the register of authorized organizations, authorized organization within 30 calendar days (in case of change of data on the status of accreditation of authorized organization in national accreditation system of state member - within 15 working days) submits to authorized body the request about modification of the specified data, and also documents confirming these changes.
35. Authorized body within 10 working days from the date of submission of the request by authorized organization about modification of the data containing in the register of authorized organizations:
a) considers the provided requests and documents specified in Item 34 of these rules;
b) sends the relevant information to the Commission with use of means of the integrated information system of the Union (in case of adoption by authorized body of the decision on modification), and also can post it on the official site on the Internet;
c) reports to authorized organization about the made decision in writing by transfer of the notification personally under list to her representative, or directs it the registered mail with the assurance of receipt, or transfers it in electronic form on telecommunication channels or in electronic form, signed by the digital signature.
36. The exception of data of the register of authorized organizations is performed in the following cases:
a) filing of application about exception of the register of authorized organizations signed by the head of authorized organization;
b) liquidation of test laboratory (center) or organization which part the test laboratory (center), as the legal entity according to the legislation of state member or cancellation of accreditation of authorized organization in national accreditation system of state member is;
c) identification of violations of procedure for carrying out researches (testing) by the body authorized according to the legislation of state member by results of the state control (supervision) exercised by it;
d) untimely submission or non-presentation of data and documents, stipulated in Item 34 these rules.
37. The authorized body within 3 working days from decision date about exception of data of the register of authorized organizations provides representation of the relevant information in the Commission with use of means of the integrated information system of the Union.
38. The commission within 1 working day from the date of receipt of the relevant information provides updating of the register of authorized organizations.
39. Provision on requests of interested persons of data on authorized organizations is performed by authorized bodies according to the legislation of state members.
to Rules of carrying out researches (testing) for the purpose of assessment of biological effect of medical products
Form of the Protocol of researches (testing) for the purpose of assessment of biological effect of medical product
_______________________________________________________________
(name of test laboratory (center))
_______________________________________________________________
(data on accreditation of test laboratory (center):
number, accreditation effective period (certificate of accreditation))
_______________________________________________________________
(address and phone number of test laboratory (center))
I claim
Head of test laboratory (center)
_____________ __________________________
(signature) (surname, initials)
"____" ____________________ 20 ____.
(date)
M.P.
The protocol of researches (testing) for the purpose of assessment of biological effect of medical product No. _________
Data on medical product:
__________________________________________________________________________________
(name, brand, model, catalog number (in the presence),
appointment and scope)
The materials of medical product and accessories to it (in the presence) contacting to human body:
__________________________________________________________________________________
Data on sample (samples) of medical product:
__________________________________________________________________________________
(quantity, identification signs (brand, model, weight, amount,
date of production (production), expiration date (service life), catalog number,
serial (serial) number (number of series, batch (lot)), etc. (when applicable))
The sample (samples) of medical product is standard sample: _____ yes ______ is not present
Information about the applicant:
__________________________________________________________________________________
(the name, the location (the address of the legal entity) - for the legal entity
or surname, name, middle name (in the presence), the residence - for physical person,
registered as the individual entrepreneur)
__________________________________________________________________________________
(contact information of the applicant (phone number, e-mail address))
Information about the producer:
__________________________________________________________________________________
(the name, the location (the address of the legal entity) - for the legal entity
or surname, name, middle name (in the presence), the residence - for physical person,
registered as the individual entrepreneur)
Data on the production site (production sites):
__________________________________________________________________________________
(the name - for the legal entity or surname, name, middle name (in the presence) -
for the physical person registered in quality
individual entrepreneur, address of the place of implementation of activities)
Basis for carrying out researches (testing):
__________________________________________________________________________________
Data on selection of sample (samples) of medical product, date of receipt of sample (samples) of medical product:
__________________________________________________________________________________
Standards, on compliance to which researches (testing) are conducted:
__________________________________________________________________________________
Methods (techniques) of researches (testing):
__________________________________________________________________________________
Venue of researches (testing):
__________________________________________________________________________________
Start date of carrying out researches (testing):
"__" _______ 20 __.
End date of carrying out researches (testing):
"__" _______ 20 __.
Conclusion: the provided samples of medical product
__________________________________________________________________________________
(correspond, do not conform to requirements - to specify necessary)
The submitted documents:
__________________________________________________________________________________
(the name, the copy or the original of the document - to specify necessary, the number of pages)
The results received from the applicant, other authorized organizations or external suppliers:
__________________________________________________________________________________
The list of the used gages, the test equipment:
__________________________________________________________________________________
Results of researches (testing):
Table No. ____
|
№ of payment order |
The document, on compliance to which the research (testing) (paragraph of the document) is conducted |
Name of indicator and (or) requirement of the document |
Method of research (testing) |
Results of research (testing) <1> |
Conditions of carrying out research (testing) (when applicable) <2> |
Conclusion |
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
|
|
|
|
|
|
|
Specialist of test laboratory (center)
______________ ______________________________
(signature) (surname, initials)
Appendix. Photographic images of general view of samples of medical product with the accessories necessary for its application to destination (in the presence), and their markings.
______________________________
<1> With indication of unit of measure, and also uncertainty of measurements (when applicable). Results shall correspond to sample of medical product for which they are received unambiguously.
<2> Temperature, humidity, atmospheric pressure, etc.
Notes:
1. On the last leaf of the protocol the following information shall be specified:
"Results of researches (testing) belong only to the samples of medical product which passed tests.
The complete or partial reprint of the this Protocol without the permission of test laboratory (center) is forbidden.".
2. In headline of the protocol information providing unique identification of the protocol, traceability of its components, and also the termination of the protocol is specified.
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