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It is registered

Ministry of Justice

Russian Federation

On July 25, 2019 No. 55388

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

of May 6, 2019 No. 3371

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

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; 2011, No. 15, Art. 2038; No. 27, Art. 3873; Art. 3880; No. 29, Art. 4291; No. 30, Art. 4587; No. 49, Art. 7061; 2012, No. 31, Art. 4322; 2013, No. 14, Art. 1651; No. 27, Art. 3477; Art. 3480; No. 30, Art. 4084; No. 51, Art. 6679; No. 52, Art. 6952; Art. 6961; Art. 7009; 2014, No. 26, Art. 3366; No. 30, Art. 4264; No. 49, Art. 6928; 2015, No. 1, Art. 67; Art. 72; No. 10, Art. 1393; No. 29, Art. 4342; Art. 4376; 2016, No. 7, Art. 916; No. 27, Art. 4293; Art. 4294; 2017, No. 1, Art. 12; No. 31, Art. 4785; No. 50, Art. 7555; 2018, No. 1, Art. 63; No. 9, Art. 1283; No. 17, Art. 2427; No. 18, Art. 2557; No. 24, Art. 3413; No. 27, Art. 3954; No. 30, Art. 4539; No. 31, Art. 4858; the official Internet portal of legal information http://www.pravo.gov.ru, on April 1, 2019), orders of the Government of the Russian Federation of December 27, 2012 No. 1416 "About approval of Rules of state registration of medical products" (The Russian Federation Code, 2013, No. 1, Art. 14; No. 43, Art. 5556; 2014, No. 30, Art. 4310; 2017, No. 8, Art. 1233; 2018, No. 24, the Art. 3523) 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; №35, of Art. 5092; 2012, No. 28, Art. 3908; No. 36, Art. 4903; No. 50, Art. 7070; No. 52, Art. 7507; 2014, No. 5, Art. 506; 2017, No. 44, Art. 6523; 2018, No. 6, Art. 880; No. 25, Art. 3696; No. 36, Art. 5623; 46, of the Art. 7050) I order to No.:

Approve the enclosed Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in state registration of medical products.

Head

M. A. Murashko

Approved by the Order of the Federal Service of the Russian Federation on supervision in health sector of May 6, 2019, No. 3371

Administrative regulations of the Federal Service on supervision in health sector on provision of the state service in state registration of medical products

I. General provisions

Subject of regulation of Administrative regulations

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

Circle of applicants

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

1) developer of medical product;

2) producer (manufacturer) of medical product;

3) authorized representative of the producer (manufacturer) of medical product.

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 and on the Single portal the following information is placed:

procedure for receipt of information by applicants concerning 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;

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

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. State service in state registration of medical products.

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 necessary and obligatory for provision of the state services <1>.

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

<1> The order of the Government of the Russian Federation of May 6, 2011 "About approval of the list of services which are federal executive bodies, State Atomic Energy Corporation "Rosatom" of the state services, necessary and obligatory for provision, and it are provided to No. 352 by the organizations participating in provision of the state services, and determination of the amount of payment for their rendering" (The Russian Federation Code, 2011, No. 20, Art. 2829; 2012, No. 14, Art. 1655; No. 36, Art. 4922; 2013, No. 33, Art. 4382; No. 49, Art. 6421; No. 52, Art. 7207; 2014, No. 21, Art. 2712; 2015, No. 50, Art. 7165; Art. 7189; 2016, No. 31, Art. 5031; No. 37, Art. 5495; 2017, No. 8, Art. 1257; No. 28, Art. 4138; No. 32, Art. 5090; No. 40, Art. 5843; No. 42, Art. 6154; 2018, No. 16, Art. 2371; No. 27, Art. 4084; No. 40, Art. 6129; 2019, No. 5, Art. 390).

Description of result of provision of the state service

11. Results of provision of the state service are:

1) issue (direction) to the applicant of the notification on state registration of medical product and the registration certificate on medical product;

2) issue (direction) to the applicant of the notification on refusal in state registration of medical product;

3) issue (direction) to the applicant of the notification on modification of the documents containing in the registration file and issue (direction) of the renewed registration certificate (in case of modification of it) and earlier issued registration certificate with mark about its invalidity (with indication of date);

4) issue (direction) to the applicant of the notification on refusal in modification of the documents containing in the registration file;

5) issue (direction) to the applicant of the duplicate of the registration certificate on medical product;

6) issue (direction) to the applicant of the decision on cancellation of state registration of medical product.

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) state registration of medical product is performed in time, not exceeding 50 working days from the date of decision making about the beginning of state registration of medical products.

The term of carrying out clinical testing of medical product does not join in 50-day time.

The term of suspension of provision of the state service is estimated from the date of adoption by Roszdravnadzor of the decision on issue of permission to carrying out clinical testing of medical product about day of adoption by Roszdravnadzor of the decision on renewal of state registration of medical product;

2) modification of the documents containing in the registration file not requiring conducting examination of quality, efficiency and safety of medical product is performed in time, not exceeding 15 working days from the date of decision making about consideration of the application about modification and documents, stipulated in Item 15 Administrative regulations.

Time from the date of the direction of the notification of Roszdravnadzor on need of elimination in the 30-day time of the revealed violations and (or) submission of documents which are absent about day of receipt of the answer to the notification is not considered in case of calculation of term of modification of the documents containing in the registration file of not requiring conducting examination of quality, efficiency and safety of medical product;

3) modification of the documents containing in the registration file requiring conducting examination of quality, efficiency and safety of medical is performed in time, not exceeding 35 working days from the date of decision making about consideration of the application about modification and documents, stipulated in Item 17 Administrative regulations.

Time from the date of Roszdravnadzor sending an inquiry about submission of required materials and data about day of receipt of reply to the request is not considered in case of calculation of term of modification of the documents containing in the registration file, requiring conducting examination of quality, efficiency and safety of medical product;

The term of registration and issue (direction) of the duplicate of the registration certificate on medical product constitutes 4) 7 working days from the date of receipt of the documents specified in Item 18 of Administrative regulations;

The term of issue (direction) of the registration certificate or notification on refusal in state registration of medical product constitutes 5) 10 working days from the date of receipt of the conclusion by results of examination of quality, efficiency and safety of medical product;

The term of issue (direction) of the notification on modification of the documents containing in the registration file and term of issue (direction) of the renewed registration certificate (in case of modification of it) constitutes 6) 10 working days from the date of receipt of the conclusion by results of examination of quality, efficiency and safety of medical product;

7) the term of issue (direction) of the notification on refusal in modification of the documents containing in the registration file, or notifications on modification of the documents containing in the registration file constitutes 10 working days from the date of receipt of the conclusion by results of examination of quality, efficiency and safety of medical product;

8) the term of issue (direction) of the notification on cancellation of state registration of medical product constitutes 3 working days from the date of signing of the order on cancellation of state registration of medical product.

The regulatory legal acts regulating provision of the state service

13. 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

14. For state registration of medical product the applicant represents (sends) the following documents to Roszdravnadzor:

1) the statement for state registration of medical product in form according to appendix No. 1 to Administrative regulations;

2) the copy of the document confirming powers of the authorized representative of the producer (manufacturer);

3) data on the regulating documentation on medical product;

4) technical documentation of the producer (manufacturer) on medical product;

5) operational documentation of the producer (manufacturer) on medical product, including the instruction for application or the operation manual on medical product;

6) photographic images of general view of medical product together with the accessories necessary for application of medical product to destination (the size at least 18 x 24 centimeters);

7) the documents confirming results of technical testing of medical product;

8) the documents confirming results of toxicological researches of medical product which use assumes availability of contact with human body;

9) the documents confirming results of testing of medical product for the purpose of approval like measuring instruments (concerning the medical products relating to measuring instruments in the sphere of state regulation of ensuring unity of measurements <2>);

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

<2> The order of the Ministry of Health of the Russian Federation of August 15, 2012 No. 89n "About approval of the Procedure for carrying out testing for the purpose of approval like measuring instruments, and also the list of the medical products relating to measuring instruments in the sphere of state regulation of ensuring unity of measurements concerning which testing for the purpose of approval like measuring instruments are carried out" (registration No. 26328) is registered by the Ministry of Justice of the Russian Federation on December 25, 2012.

10) for medical products of 1 class of potential risk of application and medical products for diagnostics of i№vitro - the data confirming clinical efficiency and safety of medical products;

11) the draft of the plan of clinical testing of medical product with the materials proving it (in the presence);

12) data on the import permits of medical products issued by Roszdravnadzor for the purpose of their state registration (for medical products of foreign production);

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