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Ministry of Justice

Russian Federation

On December 22, 2020 No. 61705

ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
AND THE FEDERAL SERVICE OF THE RUSSIAN FEDERATION ON SUPERVISION IN HEALTH SECTOR

of November 2, 2020 No. 10109

About approval of Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in licensing 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

According to the Federal Law of July 27, 2010 No. 210-FZ "About the organization of provision of the state and municipal services" (The Russian Federation Code, 2010, No. 31, Art. 4179; 2020, No. 31, the Art. 5027), the order of the Government of the Russian Federation and of May 16, 2011 No. 373 "About development and approval of administrative regulations of implementation of the state control (supervision) and administrative regulations of provision of the state services" (The Russian Federation Code, 2011, No. 22, Art. 3169; 2018, No. 46, the Art. 7050), item 4 of the Regulations on licensing 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 approved by the order of the Government of the Russian Federation of September 15, 2020 No. 1445 (The Russian Federation Code, 2020, to No. 39, of the Art. 6037), I order:

1. Approve the enclosed Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in licensing 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.

2. This order becomes effective since January 1, 2021.

Head

A. V. Samoylova

Approved by the Order of the Federal Russian Federation of service on supervision in health sector of November 2, 2020, No. 10109

Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in licensing 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

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of the Federal Service on supervision in health sector on provision of the state service in licensing 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 (further respectively - Administrative regulations, the state service) establish terms and the sequence of ministerial procedures (actions) of the Federal Service for supervision in health sector (further - Roszdravnadzor), order of interaction between structural divisions of Roszdravnadzor, his officials, and also interactions of Roszdravnadzor with applicants, other public authorities and local government bodies, the organizations by provision of the state service.

Circle of applicants

2. Applicants on provision of the state service (further - applicants) are:

1) the legal entities, individual entrepreneurs having intention to perform or performing 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 (further respectively - the license applicant, the licensee), or their authorized representatives;

2) the physical persons and legal entities which addressed for provision of data on specific license 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 (further - the license) and other information on provision of the state service.

Requirements to procedure for informing on provision of the state service

3. Informing on procedure for provision of the state service is performed:

on the official site of Roszdravnadzor on the Internet (further - the official site of Roszdravnadzor, Internet network);

on the official site in the federal state information system "Single Portal of the State and Municipal Services" (further - the Single portal);

in the federal state information system "Federal Register of the State Services (Functions)" (further - the Federal register);

at information stands in reception on work with addresses of citizens;

on phone numbers for reference.

4. Reference information concerning provision of the state service is placed:

on the official site of Roszdravnadzor;

on the Single portal;

in the Federal register;

at information stands.

5. Reference information is provided by officials of Roszdravnadzor by phone, on personal acceptance of the applicant or in writing the mailing or the electronic message to the address specified by the applicant.

Reference information includes data on the location, the working schedule, telephone numbers for enquiries, number of phone informant, addresses of the official site, e-mail and (or) form of feedback with Roszdravnadzor.

6. On the official site of Roszdravnadzor, information stands, in the Federal register, on the Single portal the following information is placed:

procedure for receipt of information by applicants concerning provision of the state service;

the exhaustive list of the documents necessary for provision of the state service, the requirement to execution of the specified documents, and also the list of documents which the applicant has the right to provide on own initiative;

circle of applicants;

term of provision of the state service;

data on the course of provision of the state service;

results of provision of the state service, procedure for submission of the document which is result of provision of the state service;

about the applicant's right to pre-judicial (extrajudicial) appeal of actions (failure to act) and the decisions made (performed) during provision of the state service;

the forms of statements (notifications, messages) used by provision of the state service;

the list of the regulatory legal acts of the Russian Federation regulating provision of the state service;

text of Administrative regulations.

7. Information on the Single portal and the official site of Roszdravnadzor on procedure and terms of provision of the state service based on the data containing in the Federal register is provided to the applicant on a grant basis.

II. Standard of provision of the state service

Name of the state service

8. The state service in licensing 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.

The name of the body providing the state service

9. The state service is provided by Roszdravnadzor.

10. It is forbidden to demand from the applicant of implementation of actions the, including coordination necessary for receipt of the state service and connected with the appeal to other state bodies and the organizations, except for receipts of the services included in the list of services which are federal executive bodies, State Atomic Energy Corporation "Rosatom" of the state services, necessary and obligatory for provision, and are provided by the organizations participating in provision of the state services, No. 352 <1> approved by the order of the Government of the Russian Federation of May 6, 2011 (further - the List of services).

--------------------------------

<1> Russian Federation Code, 2011, No. 20, Art. 2829; 2020, No. 39, Art. 6038.

Description of result of provision of the state service

11. Results of provision of the state service are:

1) provision (refusal in provision) licenses;

2) renewal (refusal in renewal) licenses;

3) provision of data from the register of licenses;

4) cancellation of the license according to the statement of the licensee.

The term of provision of the state service, including taking into account need of the appeal to the organizations participating in provision of the state service, the term of suspension of provision of the state service if the possibility of suspension is stipulated by the legislation the Russian Federation, the term of issue (direction) of the documents which are result of provision of the state service

12. The term of provision of the state service and issue (direction) of the documents which are result of provision of the state service:

1) decision making about provision (about refusal in provision) licenses - 45 working days from the date of receipt in Roszdravnadzor of properly issued application for provision of the license and documents (data), stipulated in Item 15 Administrative regulations;

2) decision making about renewal (about refusal in renewal) licenses (in cases of reorganization of the legal entity in the form of transformation, merge, change of its name, the location address, and also in cases of change of the residence, name, surname and middle name of the individual entrepreneur, details of the document proving his identity, the terminations of activities for one address or several addresses of places of its implementation specified in the license) - 10 working days from the date of receipt in Roszdravnadzor of properly issued application for renewal of the license and documents (data) provided by Items 16 and 19 of Administrative regulations;

3) decision making about renewal (about refusal in renewal) licenses (in cases of change of addresses of places of implementation by the legal entity, individual entrepreneur of the licensed type of activity, the list of the performed works, the rendered services constituting the licensed type of activity) - 30 working days from the date of receipt in Roszdravnadzor of properly issued application for renewal of the license and the documents provided by Items 17 and 18 of Administrative regulations;

4) issue (direction) of the notification on provision (renewal) of the license - 3 working days from the date of entering of record about provision (renewal) of the license into the register of licenses;

5) cancellation of the license - 10 working days from the date of receipt in Roszdravnadzor of properly issued application for the termination 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, stipulated in Item 20 Administrative regulations;

6) provision of data from the register of licenses - 3 working days from the date of receipt in Roszdravnadzor of properly issued application, stipulated in Item 21 Administrative regulations.

13. The term of suspension of provision of the state service - 30 calendar days from the date of receipt by the applicant of the notification on need of elimination in the 30-days time of the revealed violations and (or) submission of documents which are absent:

1) in case of filing of application about provision of the license, Item 15 of Administrative regulations which is drawn up with violation, and submission of documents not in full;

2) in case of filing of application about renewal of the license, drawn up with violation of Items 16 - 19 Administrative regulations, and (or) submission of documents not complete amount.

The regulatory legal acts regulating provision of the state service

14. The list of the regulatory legal acts regulating provision of the state service is posted on the official site of Roszdravnadzor, in the Federal register and on the Single portal.

The exhaustive list of the documents necessary according to regulatory legal acts for provision of the state service and services which are necessary and obligatory for provision of the state service, subject to representation by the applicant, methods of their obtaining by the applicant, including electronically, procedure for their representation

15. For receipt of the license the license applicant represents (sends) the following documents (data) to Roszdravnadzor:

1) the statement for provision of the license in form according to Appendix No. 1 to Administrative regulations in which are specified:

a) complete and (if is available) the abbreviated name, including trade name, and form of business of the legal entity, the address of its location, the address of places of implementation of the licensed type of activity which the license applicant intends to perform the state registration number of record about creation of the legal entity, data of the document confirming the fact of entering of information about the legal entity into the Unified State Register of Legal Entities with indication of phone number and (if is available) the e-mail address of the legal entity;

b) surname, name, middle name (in the presence) the individual entrepreneur, the address of its residence, the address of places of implementation of the licensed type of activity which the license applicant intends to perform data of the document proving his identity, the state registration number of record about state registration of the individual entrepreneur, data of the document confirming the fact of entering of information about the individual entrepreneur into the Unified State Register of Private Entrepreneurs with indication of phone number and (if is available) the e-mail address of the individual entrepreneur;

c) identification taxpayer number, data of the document on statement of the license applicant on accounting in tax authority;

d) the licensed type of activity which the license applicant intends to perform with indication of the performed works (the rendered services) constituting activities for production and maintenance of medical equipment according to appendix to the Regulations on licensing of activities for the production and maintenance (except for case, if maintenance is performed for ensuring own needs of the legal entity or the individual entrepreneur) medical equipment approved by the order of the Government of the Russian Federation of September 15, 2020 No. 1445 <2> (further - Regulations on licensing 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);

--------------------------------

<2> Russian Federation Code, 2020, No. 39, Art. 6037.

2) 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 production and maintenance of medical equipment, the rights to which are not registered in the Single state real estate register (if such rights are registered in the specified register, - data on these buildings and (or) rooms);

3) for implementation of activities for production of medical equipment:

a) copies of the documents confirming availability at the license applicant on the property right or on other legal cause of the measuring instruments provided by regulating, technical documentation of the producer and conforming to requirements to their checking, the stipulated in Article 13 Federal Laws of June 26, 2008 No. 102-FZ "About ensuring unity of measurements"> (further - the Federal Law of June 26, 2008 No. 102-FZ), the technical means and the equipment necessary for implementation of activities for production of medical equipment;

--------------------------------

<3> Russian Federation Code, 2008, No. 26, Art. 3021; 2019, No. 52, Art. 7814.

b) the copy of the agreement between the producer (the authorized representative of the producer) and the license applicant (production site) about production organization (in the presence);

c) copies of the documents confirming production compliance to requirements of the state standard specification ISO 13485-2017 Interstate standard "Products medical. Quality management system. Requirements for the purposes of regulation", the accepted Interstate council on standardization, metrology and certification on June 7, 2017 (the protocol of June 7, 2017 No. 99-P) and the order of Federal Agency for Technical Regulation and Metrology enacted since June 1, 2018 of June 30, 2017 No. 615 of St (further - GOST ISO 13485-2017);

d) copies of regulating, technical documentation on medical equipment which the license applicant intends to make;

e) copies of the documents confirming availability at the workers of the license applicant who signed employment contracts with the license applicant responsible for production and quality of medical equipment, 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 sphere of the performed works and the rendered services;

4) for implementation of activities for maintenance of medical equipment:

a) 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 of June 26, 2008 No. 102-FZ, the technical means and the equipment necessary for maintenance of the declared groups of medical equipment on classes of potential risk of application;

b) 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;

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

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