ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 15, 2020 No. 1445

About approval of the Regulations on licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application)

List of amending documents

According to the Federal Law "About Licensing of Separate Types of Activity" Government of the Russian Federation decides:

1. Approve the enclosed Regulations on licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application).

2. The licenses for activities on production and maintenance (except for case, if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment issued before entry into force of this resolution are subject to renewal according to requirements of the Provision approved by this resolution till December 31, 2023.

3. To the Federal Service on supervision in the field of health care till July 1, 2021 to staticize data of register entries of the unified register of the licenses containing data on production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment which according to the Provision approved by this resolution do not require receipt of the license.

4. This resolution becomes effective since January 1, 2021 and is effective till January 1, 2027.

Approved by the Order of the Government of the Russian Federation of September 15, 2020 No. 1445

Regulations on licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application)

1. This Provision determines procedure for licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application).

2. The licensed activities for maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also except for case of maintenance of medical products with low degree of potential risk of their application) medical products represent periodic and unplanned technical diagnosing, maintenance, installation and adjustment of medical products from groups on classes of potential risk of their application according to appendix for which these works are provided by regulating, technical or operational documentation of the producer.

If for medical product regulating, technical or operational documentation of the producer does not provide actions for periodic and unplanned technical diagnosing, maintenance, installation and adjustment or it cannot be carried to one of groups of medical products according to class of potential risk of their application according to appendix, activities for maintenance of working capacity or operability of such medical products are not subject to licensing.

3. The structure of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application) (further - activities for maintenance of medical products) includes works (service) in the list according to appendix.

4. Licensing of activities for maintenance of medical products is performed by the Federal Service on supervision in the field of health care (further - the licensing body).

The licensing body approves document forms, necessary for realization of this provision (forms of the submitted applications, notifications and data).

5. Licensed requirements when implementing activities for maintenance of medical products are:

a) availability at the license applicant:

belonging to it on the property right or on other legal cause of the rooms, buildings, constructions in the place of implementation of the licensed type of activity necessary for implementation of activities for maintenance of medical products;

paragraphs 3 - 9 voided

the measuring instruments conforming to requirements to their checking, the stipulated in Article 13 Federal Laws "About Ensuring Unity of Measurements", the technical means and the equipment necessary for maintenance of the declared groups of medical products on classes of potential risk of application according to the list approved by the Ministry of Health of the Russian Federation;

the operational documentation of the producer of medical products necessary for maintenance of the declared groups of medical products on classes of potential risk of application;

the quality management system created and functioning according to requirements of the state standard specification ISO 13485-2017 interstate standard;

the workers (in case of accomplishment of 1 or 2 work types (services) - at least 2 people, in case of accomplishment of 3 or 4 work types (services) - at least 3 people, in case of accomplishment of 5 and more work types (services) - at least 5 people) who signed employment contracts with the license applicant, performing maintenance of the medical products having the higher or secondary professional (technical) education, length of service in at least 3 years and additional professional education (advanced training at least once in 5 years) in the field of the performed works and the rendered services;

b) for the licensee:

availability belonging to the licensee on the property right or on other legal cause of the rooms, buildings, constructions in the place of implementation of the licensed type of activity necessary for implementation of activities for maintenance of medical products;

paragraphs 3 - 9 voided

availability belonging to the licensee on the property right or on other legal cause of the measuring instruments provided by regulating, technical documentation and conforming to requirements to their checking, the stipulated in Article 13 Federal Laws "About Ensuring Unity of Measurements", the technical means and the equipment necessary for maintenance of the declared groups of medical products on classes of potential risk of application according to nomenclature classification of medical products by classes depending on potential risk of their application;

observance of requirements of operational documentation of the producer of medical products when implementing maintenance of the declared groups of medical products on classes of potential risk of application;

observance of requirements of the quality management system created and functioning according to requirements of the state standard specification ISO 13485-2017 interstate standard;

availability at the licensee of the workers (in case of accomplishment of 1 or 2 work types (services) - at least 2 people, in case of accomplishment of 3 or 4 work types (services) - at least 3 people, in case of accomplishment of 5 and more work types (services) - at least 5 people) who signed employment contracts with it, performing maintenance of the medical products having the higher or secondary professional (technical) education, length of service in at least 3 years and additional professional education (advanced training at least once in 5 years) in the field of the performed works and the rendered services.

6. Violations by the licensee of requirements, stipulated in Item the 5th this provision, the entailed effects established by part 11 of article 19 of the Federal law "About Licensing of Separate Types of Activity" belong to gross violations of licensed requirements.

7. For receipt of license for activities on maintenance of medical products the license applicant directs or represents the application to which the list of documents is enclosed to the licensing body, and also:

a) copies of the documents confirming availability at the license applicant belonging to it on the property right or on other legal cause of the rooms, buildings, constructions in the place of implementation of the licensed type of activity necessary for implementation of activities for maintenance of medical products if information on them is absent in the Single state real estate register, or data on these rooms, buildings, constructions if such information is available in the specified register;

b) ceased to be valid

c) for implementation of activities for maintenance of medical products:

copies of the documents confirming availability at the license applicant on the property right or on other legal cause of the measuring instruments conforming to requirements to their checking, the stipulated in Article 13 Federal Laws "About Ensuring Unity of Measurements", the technical means and the equipment necessary for maintenance of the declared groups of medical products on classes of potential risk of application according to nomenclature classification of medical products by classes depending on potential risk of their application;

copies of the documents confirming availability at the license applicant of the quality management system conforming to requirements of the state standard specification ISO 13485-2017 interstate standard;

copies of operational documentation of the producer on medical products, necessary for maintenance of the declared groups of medical products on classes of potential risk of application;

copies of the documents confirming availability at the workers of the license applicant who signed employment contracts with the license applicant, performing maintenance of medical products, the higher or secondary professional (technical) education, length of service in at least 3 years and additional professional education (advanced training at least once in 5 years) in the field of the performed works and the rendered services.

8. On maintenance of medical products the licensee specifies in the statement for renewal of license for activities:

a) in case of implementation of activities for maintenance of medical products to the address of the place of its implementation which is not provided by the license:

the data containing the address of the place of implementation of activities;

data on the documents confirming the property right or other legal cause of use of rooms, buildings, constructions in the place of implementation of the licensed type of activity necessary for implementation of activities for maintenance of medical products;

paragraphs 4 - 10 voided

maintaining about the documents confirming availability at the licensee on the property right or on other legal cause of the measuring instruments conforming to requirements to their checking, the stipulated in Article 13 Federal Laws "About Ensuring Unity of Measurements", the technical means and the equipment necessary for maintenance of the declared groups of medical products on classes of potential risk of application according to nomenclature classification of medical products by classes depending on potential risk of their application;

details of the operational documentation of the producer necessary for maintenance of the declared groups of medical products on classes of potential risk of application (in the presence);

details of the documents confirming availability at the licensee of the quality management system conforming to requirements of the state standard specification ISO 13485-2017 interstate standard;

data on documents on the higher or secondary professional (technical) education, length of service in at least 3 years and additional professional education (advanced training at least once in 5 years) in the field of the performed works and the rendered services of the workers who signed employment contracts with the licensee, performing maintenance of medical products;

b) in case of intention of the licensee to perform works, to render the services constituting activities for maintenance of medical products, which are not provided by the license:

data on the works, services constituting activities for maintenance of medical products which the licensee intends to carry out, render;

paragraphs 3 - 9 voided

data on the documents confirming availability at the licensee on the property right or on other legal cause of the measuring instruments conforming to requirements to their checking, the stipulated in Article 13 Federal Laws "About Ensuring Unity of Measurements", the technical means and the equipment necessary for maintenance of the declared groups of medical products on classes of potential risk of application according to nomenclature classification of medical products by classes depending on potential risk of their application;

details of the operational documentation of the producer necessary for maintenance of the declared groups of medical products on classes of potential risk of application;

details of the documents confirming availability at the licensee of the quality management system conforming to requirements of the state standard specification ISO 13485-2017 interstate standard;

data on documents on the higher or secondary professional (technical) education, length of service in at least 3 years and additional professional education (advanced training at least once in 5 years) in the field of the performed works and the rendered services of the workers who signed employment contracts with the licensee, performing maintenance of medical products.

9. Performance of works, rendering services regarding maintenance of medical products can be performed by the licensee to the address of operation (location) of medical products which is not provided by the license as the address of the place of implementation of the licensed type of activity and do not require renewal of the license.

10. When conducting verification of the data containing in the documents provided by the license applicant and the licensee the statement and attached to it, the licensing body requests necessary for provision of the state services in the field of licensing of the data, being at the disposal of the bodies providing the state services, the bodies providing municipal services, other state bodies, local government bodies or subordinated to state bodies or local government bodies of the organizations, according to the procedure, established by the Federal Law "About the Organization of Provision of the State and Municipal Services".

11. The licensing body places on the single portal of the state and municipal services (functions) according to the procedure established by the Government of the Russian Federation, data on the course of adoption by it of the decision on provision or renewal of the license, and also conducting check of compliance of the license applicant to licensed requirements and checks of observance by the licensee of the specified requirements when implementing activities for maintenance of medical products.

12. The information relating to implementation of activities for maintenance of medical products, provided by parts 1 and 2 of article 21 of the Federal law "About Licensing of Separate Types of Activity" is posted on the official site of the licensing body on the Internet.

Access to the public information containing in the register of licenses is provided with the licensing body by means of its placement on the Internet, including in the form of open data. The data on licenses containing in the register of licenses receive the status of open data when entering the corresponding record into the register which is kept in electronic form.

Up-to-date information from the register of licenses shall be displayed on the Internet in real time or during the term which is not exceeding 5 minutes.

13. Assessment of observance by licensees of licensed requirements when implementing activities for maintenance of medical products is performed within federal state control (supervision) of the address of medical products.

14. Ceased to be valid according to the Order of the Government of the Russian Federation of 30.11.2021 No. 2129

15. Ceased to be valid according to the Order of the Government of the Russian Federation of 30.11.2021 No. 2129

16. Ceased to be valid according to the Order of the Government of the Russian Federation of 30.11.2021 No. 2129

17. Ceased to be valid according to the Order of the Government of the Russian Federation of 30.11.2021 No. 2129

18. Ceased to be valid according to the Order of the Government of the Russian Federation of 30.11.2021 No. 2129

19. Ceased to be valid according to the Order of the Government of the Russian Federation of 30.11.2021 No. 2129

20. Submission by the license applicant of the statement and the documents necessary for receipt of the license, their acceptance by the licensing body, acceptance by the licensing body of the decision on provision of the license (about refusal in provision of the license), renewal, suspension or renewal of its action, and also maintaining information resource and the register of licenses and provision of the data containing in information resource and the register of licenses are performed according to the procedure, established by the Federal Law "About Licensing of Separate Types of Activity".

21. The state fee in sizes and procedure which are established by the legislation of the Russian Federation on taxes and fees is paid for provision by the licensing body of the license and renewal of the license.

Appendix

to Regulations on licensing of activities for maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application)

The list of the performed works, the rendered services as a part of activities for production and maintenance (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment

1. No. 2129 is excluded according to the Order of the Government of the Russian Federation of 30.11.2021

2. Regarding maintenance of medical products (except for case if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur, and also case of maintenance of medical products with low degree of potential risk of their application):

a) maintenance of the following groups of medical products of class 2a of potential risk of application:

orthopedic medical products;

gastroenterologichesky medical products;

the rehabilitation and adapted for disabled people medical products;

medical products for plastic surgery, dermatology and cosmetology;

auxiliary and all-hospital medical products;

dental medical products;

anesteziologichesky and respiratory medical products (monitors, systems of monitoring anesteziologichesky, respiratory);

neurological medical products;

cardiovascular medical products (medical products for determination of physiological parameters, mapping of heart, monitors, systems of monitoring the cardiological and accompanying products);

ophthalmologic medical products;

medical products for otorhinolaryngology;

physiotherapeutic medical products;

medical products for diagnostics in vitro (registered in accordance with the established procedure according to the acts constituting the right of the Eurasian Economic Union or the legislation of the Russian Federation);

b) maintenance of groups of medical products of class 2b of potential risk of application:

surgical instruments, systems and the accompanying medical products;

cardiovascular medical products (except for medical products for determination of physiological parameters, mapping of heart, monitors, systems of monitoring of the cardiological and accompanying products);

medical products for manipulations, recovery of fabrics, human organs;

medical products for obstetrics and gynecology;

anesteziologichesky and respiratory medical products (except for monitors, systems of monitoring anesteziologichesky, respiratory);

radiological medical products (regarding the equipment for ultrasonography);

radiological medical products (regarding the gamma and diagnostic, gamma and therapeutic equipment and issued tomography);

radiological medical products (regarding the equipment for magnetic and resonant tomography);

radiological medical products (regarding the equipment for X-ray therapy);

radiological medical products (regarding the x-ray equipment for computer tomography and angiography);

radiological medical products (regarding the equipment for X-ray analysis and roentgenoscopy);

c) maintenance of groups of medical products of class 3 of potential risk of application:

urological medical products;

the medical products intended for aferez.

 

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