On approval of the rules of state registration of medical devices. Procedure for re-registration of medical devices Replacement of a form of a registration certificate for a medical

Roszdravnadzor in his appeal on August 26 made it clear that she did not intend to extend the period for another 5 years, as it believes that registration certificate A new time sample is sufficient, given that the procedure lasts only 30 days.

The Ministry of Health went to meet manufacturers who declared the impossibility of getting new ru on time.

On the official website to accommodate information on the preparation of federal authorities executive power Projects of regulatory legal acts have emerged a draft resolution, which states that the validity period of registration certificates for medical products will be extended and medical technique indefinitely issued until the day of entry into force of the Government Decision Russian Federation dated December 27, 2012 1416 "On approval of rules state registration medical devices», until December 31, 2021

Discussion of the draft document will last until October 31, 2016. FROM full text The draft resolution can be found on the link.

Industrialists, in turn, pondered by the end of 2021 to re-register their products under the new rules of the Eurasian Economic Union (EAEU).

k) for medical devices 1 class of potential risk of application and medical devices for diagnostics in vitro - information confirming the clinical efficacy and safety of medical devices;

Change information:

The registering authority accepts a statement of registration and documents provided for in paragraph 10 of these Rules, according to an inventory, a copy of which with a mark on the date of reception specified statements and documents on the day of reception are given to the applicant or sent to him by registered mail with the notice of the presentation or in electronic form According to telecommunication channels of communication.

14. The registering authority is not entitled to require the applicant to indicate in the registration application not provided for in paragraph 9 of these Rules, and to submit documents not provided for in paragraph 10 of these Rules.

15. Within 5 working days from the date of receipt of an application for registration and documents stipulated by clause 10 of these Rules, the registering authority conducts an inspection of the completeness and accuracy of the information contained in them, including by comparing such information provided in accordance with the procedure for interdepartmental information interaction. .

16. In the event that the registration application is issued in violation of the provisions of paragraph 9 of these Rules and (or) in the application, there are no documents provided for in paragraph 10 of this Regulation, not in full, the registering authority presents the applicant notification of the need to eliminate the 30-day period of identified violations and (or) submission of documents that are missing or sends such a notification by registered mail with a notice of a presentation or in form electronic documentsigned by electronic signature

The notification in the case of its direction by registered mail is considered received after 10 working days from the date of the notification direction.

17. Within 3 working days from the date of submission of a properly decorated application for registration and in full documents provided for in paragraph 10 of these Rules, as well as in the event of a 6-day period of violations of violations and (or) submission of documents provided for in paragraph 10 This Regulation, the registering authority decides on the start of state registration of medical devices.

18. In case, within 30 days, the identified violations and (or) are not presented documents that are missing, the registering authority decides on the return of registration and documents provided for in paragraph 10

19. State registration of medical devices is carried out by the registering authority within a period not exceeding 50 working days from the date of decision on the start of state registration of medical devices.

The deadline for clinical testing of the medical product in a 50-day term is not included.

20. Within 3 working days from the date of decision on the start of state registration of medical devices, the registering authority issues and issues a task for examination of the quality, efficiency and safety of the medical device by federal state budget institutionThe registering authority (hereinafter referred to as an expert institution).

21. The examination of the quality, efficacy and safety of the medical product is carried out by an expert institution in stages in accordance with the procedure approved by the Ministry of Health of the Russian Federation:

b) at stage II, an examination of the completeness and results of the conducted technical tests, toxicological studies, clinical trials, as well as tests in order to approve the type of measuring instruments (in relation to medical devices related to the measurement funds in the field of state regulation of ensuring the unity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation) (hereinafter - the expertise of completeness and test results and research).

21.1. During the examination of the quality, efficiency and safety of the medical product (at any stage), the applicant's expert institution is not allowed to be applied by the applicant or other persons necessary for the examination.

In case of failure to make an expert in the conclusion of materials and information contained in the applicant submitted by the Application for registration and documents provided for in paragraph 10 of these Rules, the expert puts the question of the introduction of the necessary materials and information to the head expert institutionwhich applies to the relevant request to the registering authority issued a task for examination. The registering authority within 2 working days from the date of receipt of the request of the head of the expert institution sends a request to the applicant about the submission of the necessary information indicating the nature of the comments and the method of eliminating them. This request is sent once at each stage of the quality examination, efficiency and safety of the medical product and can be transferred to the authorized representative of the applicant personally for receipt, sent by registered mail with a notice of a presentation or transferred in electronic form to telecommunication channels or in the form of an electronic document signed electronic signature.

The applicant is obliged to submit an answer to the request of the registering authority within a period not exceeding 50 working days from the date of receipt of this request. Within 2 working days from the date of receipt from the applicant, the response to the request the registering authority sends such an answer to the expert institution. In case of failure after 50 working days, the applicant's response to the request of the registering authority within 2 business days aims to the expert institution a notice of failure to submit an answer to the request of the registering authority to prepare the conclusion of an expert institution on the basis of documents available at its disposal.

In the event that the response to the request, as well as the documents attached to it, are compiled in a foreign language, they are submitted to the translation certified in the prescribed manner into Russian.

When identifying the registering authority in the applicant submitted in response to the request of documents of unreliable and (or) lack of data or documents, compiled or containing text in a foreign language without translation in the prescribed manner into Russian, the registering authority provides for 2 working days (sends to registered mail Departing with a notification of the presentation or in the form of an electronic document signed by an electronic signature, or in electronic form on telecommunication channels) to the applicant's decision on the return specified documents With a motivated substantiation of the reasons for the return and the message about the possibility of re-submitting the applicant before the expiration of 50 working days from the date of receipt of the request for the finalized documents. In case of failure to submit the applicant to the specified period of the requested materials and information of the quality examination, the effectiveness and safety of the medical product continues at the expert institution that has previously submitted to the applicant and information contained in the registration file.

22. At the stage of the quality examination, the effectiveness and safety of the medical device, an expert institution within a period not exceeding 20 working days from the date of receipt of the task is carried out by the following activities:

a) conducting an examination of an application for registration and documents provided for in paragraph 10 of these Rules to determine the possibility (inexpensability) of the clinical testing of the medical product;

b) Registration and direction to the registering body of the conclusion about the possibility (inexpensability) of the clinical testing of a medical product (indicating the reasons and the rationale for the impossibility of their holding), the form of which is approved by the Ministry of Health of the Russian Federation.

23. The basis for an expert institution of concluding about the impossibility of clinical testing of the medical product or the impossibility of state registration of a medical product is:

a) non-compliance with medical device requirements regulatory documentation, technical and (or) operational documentation of the manufacturer (manufacturer);

b) the lack of evidence of the security of the medical product.

24. The registering authority within 5 working days from the date of receipt from the expert institution of the conclusion of the possibility (inexpensability) of the clinical testing of the medical product is carried out by the following activities:

a) An assessment of the conclusion to determine the compliance of the task to conduct an examination of the quality, efficiency and safety of the medical product. In the event of a non-compliance of the conclusion of an expert institution, this conclusion is returned to the expert establishment for refinement, the period of which is no more than 2 working days from the date of receipt by the expert institution of the returned conclusion;

b) making a decision on issuing permission to conduct clinical tests of a medical product or refusal to state registration of a medical product, which is issued by the order of the registering authority, and notify the applicant about the decision taken;

c) issuance (by registered mail with a notification of the presentation or in the form of an electronic document signed by an electronic signature) to the applicant for the conduct of clinical tests of the medical product, the form of which is approved by the registering authority, and making appropriate information into the register of issued permits for clinical tests of medical Products, the procedure for which is approved by the registering authority, or notification of refusal to the state registration of a medical product, indicating the reasons for refusal.

25. The basis for making a decision on refusal to state registration is to receive the registering authority from an expert institution of concluding about the impossibility of conducting clinical tests of the medical product.

Clinical tests of the medical product, with the exception of medical products 1 of the potential risk of application and medical devices for diagnostics in vitro, are carried out on the basis of permission to carry out clinical trials issued by the registering authority, as well as the conclusion on the ethical substantiation of clinical trials issued by the Council on the Ethics of the Ministry Health of the Russian Federation, in cases established by the specified rules.

37. To changes that contribute to the documents contained in the registration dossier, which do not require the examination of the quality, efficiency and safety of the medical product include:

a) change the applicant information, including information:

about change of name legal entity (full and (in case there is) abbreviated, including branded name), addresses of its location;

on changing the last name, name and (in case there is) patronymic, addresses of residence individual entrepreneur and details of a document certifying his personality;

b) Changing the information about the face, in the name of which a registration certificate may be issued, including information:

on the reorganization of a legal entity;

on changing the name of the legal entity (complete and (if there is) abbreviated, including branded name), addresses of his location or surname, name, and (in case there is) patronymic, the place of residence of an individual entrepreneur;

c) change the address of the production site (manufacturing) of the medical product;

d) change the name of the medical unit if the properties and characteristics have not changed, affecting the quality, efficacy and safety of the medical product, or their properties and characteristics are improved with the immutability and (or) principle of operation, providing:

adding (exclusion) of the accessories of a medical product or a change in their name;

note, change and exception trademark and other means of individualization of the medical product;

changing the number of units of the medical product or its component partscomponents specified in the application to the registration certificate;

specifying or eliminating the options (models) of the medical product;

changing marking and (or) packaging of the medical product;

e) a change in the manufacturer (manufacturer) of the medical device for the validity of the documents contained in the registration dossier;

(e) Changing information about the authorized representative of the manufacturer (manufacturer) of the medical product.

Change information:

Paragraph 38 Changed from June 13, 2018 - Resolution

38. For submission to the documents contained in the registration file, the changes specified in paragraph 37 of this Regulation, the applicant no later than 30 working days from the date of the change of the relevant data represents (sends) to the registering authority:

a) an application for amending the documents contained in the registration dossier (hereinafter referred to as amending the amendments), issued in accordance with paragraph 9 of these Rules;

b) a copy of the document confirming the authority of the authorized representative of the manufacturer (manufacturer);

c) documents and information on relevant changes, including documents confirming the changes specified in subparagraphs "A" - "in" clause 37 of these Rules, as well as in the event of a change in the name of the medical product:

information about the regulatory documentation for the medical product;

technical documentation of the manufacturer (manufacturer) on the medical product, summarized with the new name of the medical product;

the operational documentation of the manufacturer (manufacturer) for a medical product (including instructions for use or manual for the operation of the medical product), summarized with the new name of the medical product;

photographic images general view medical products together with accessories necessary for the use of a medical product for the purpose (the size of at least 18 centimeters in length and 24 centimeters in width);

d) documents of the manufacturer and (or) organizations carrying out technical testing, toxicological research, clinical trials (results of appropriate tests) confirming that the introduction of the stated changes does not entail changes in properties and characteristics affecting the quality, efficacy and safety of the medical product, or Improves properties and characteristics with the immutability and (or) principle of the medical product;

e) the original registration certificate (duplicate);

e) Inventory documents.

Change information:

Item 39 Changed from June 13, 2018 - Resolution of the Government of Russia of May 31, 2018 N 633

39. Amendments to the documents specified in subparagraphs "in" and "g" of paragraph 10 of these Rules (except for the cases specified in subparagraph "G" of paragraph 37 of these Rules), is carried out according to the results of the quality examination, efficiency and safety of the medical product, conducted in a manner, similar to the procedure for conducting quality examination, efficiency and safety of a medical product for its state registration in accordance with paragraph 21 of these Rules, if the registering authority on the results of the inspection of the completeness and reliability of the information contained in the documents submitted is established that the introduction The stated changes entails the change in properties and characteristics affecting the quality, efficacy and safety of the medical product, or improves its properties and characteristics with the immutability and (or) principle of the medical product.

Change information:

Item 40 changed from June 13, 2018 - Resolution of the Government of Russia of May 31, 2018 N 633

40. In the event that the documents stipulated by paragraph 38 of these Rules are compiled in a foreign language, they are submitted to the translation certified in the prescribed manner.

Change information:

Paragraph 41 changed from June 13, 2018 - Resolution of the Government of Russia of May 31, 2018 N 633

Change information:

Item 42 Changed from June 13, 2018 - Resolution of the Government of Russia of May 31, 2018 N 633

42. The registering authority is not entitled to require the applicant to submit documents not provided for in paragraph 38 of these Rules.

Change information:

Paragraph 43 changed from June 13, 2018 - Decree of the Government of Russia of May 31, 2018 N 633

Change information:

Paragraph 44 Changed from June 13, 2018 - Decree of the Government of Russia of May 31, 2018 N 633

44. In the event that the application for amending the amendments are not included in accordance with subparagraphs "B" - "E" of clause 38 of these Rules and (or) in a statement about making changes, there are false information or documents provided for by paragraph 38 of this Regulation are presented Not in full, the registering authority presents the applicant notification of the need to eliminate in a 30-day term of identified violations and (or) submission of documents that are missing, or directs such a notification in the form of an electronic document signed by an electronic signature, or in electronic telecommunication channels Communication, or by registered mail with a notice of delivery.

Change information:

Paragraph 45 Changed from June 13, 2018 - Resolution of the Government of Russia of May 31, 2018 N 633

45. Within 3 working days from the date of submission of a properly decorated application for amending and in full documents provided for in paragraph 38 of this Regulation, the registering authority decides on the consideration of the specified statements and documents or (if they are discrepted to the provisions of paragraph 38 of this Regulation ) On their return with a motivated substantiation of the reasons for the return.

Change information:

Item 46 Changed from June 13, 2018 - Resolution of the Government of Russia of May 31, 2018 N 633

Change information:

Item 47 Changed from June 13, 2018 - Resolution of the Government of Russia of May 31, 2018 N 633

47. Making changes to the documents contained in the registration dossier that do not require the examination of the quality, efficacy and safety of the medical product is carried out by the registering authority within a period not exceeding 15 working days from the date of the decision to consider the application for amending and the documents provided for by paragraph 38 of these Rules.

Amendments to the documents contained in the registration dossier requiring the examination of the quality, efficacy and safety of the medical product, is carried out by the registering authority within a period not exceeding 35 working days from the date of the decision to consider the application for amending and the documents provided for in paragraph 38 of this Regulation .

49. When making changes to the documents contained in the registration dossier, the registering authority performs the following activities:

a) making a decision on amending the documents contained in the registration dossier, which is issued by the order of the registering authority;

b) issuance of an expert assistance to the quality examination, the effectiveness and safety of the medical product and the assessment of the conclusion of an expert institution to determine the conformity of its task to conduct an examination of the quality, efficiency and safety of the medical product (in the case of paragraph 39 of these Rules). In the event of a non-compliance of the conclusion of an expert institution, this conclusion is returned to the expert establishment for refinement, the period of which is no more than 2 working days from the date of receipt by the expert institution of the returned conclusion;

c) notification in the applicant's written form about the decision by registered mail with the notification of the presentation or in the form of an electronic document signed by electronic signature, or in electronic form on telecommunication channels of communication with the application of a reissued registration certificate (in case of changes to it) and earlier Announced registration certificate with a mark of its invalidity (indicating the date).

Change information:

Rules are supplemented by clause 49.1 from June 13, 2018 - RESOLUTION OF GOVERNMENT OF RUSSIA of 31 May 2018 N 633

49.1. The grounds for making an expert establishment of the impossibility of making changes to the documents provided for by subparagraphs "in" and "g" of paragraph 10 of these Rules are:

a) the unreliability of the presented information substantiating changes, including those identified by the registering authority state control for the appeal of medical devices;

b) the absence in the applicant's documents submitted by the applicant confirming that the changes made to the documents contained in the registration dossier are not entitled to the change in the properties and characteristics affecting the quality, efficacy and safety of the medical product, or improve the properties and characteristics when determined and functional purposes and (or) the principle of the medical product.

Change information:

The rules are complemented by clause 49.2 from June 13, 2018 - RESOLUTION OF THE GOVERNMENT OF RUSSIA of 31 May 2018 N 633

49.2. The registering authority within 2 working days from the date of obtaining the conclusion of the expert institution decides on the possibility (inexpensability) of making changes to the documents contained in the registration file, and notifies the applicant's adopted decision by registered mail with the notice of a presentation or in the form of an electronic document signed electronic signature, or in electronic form in telecommunication channels.

The basis for making a decision on refusal to make changes to the documents contained in the registration file is obtaining a registering authority from an expert institution of concluding about the impossibility of making changes to the documents contained in the registration dossier of the medical product.

Clause 52 of paragraph 38 of these Rules, as well as a statement on the provision of duplicate;

b) a copy of the task to carry out the examination of the quality, efficacy and safety of a medical device, designed by the registering authority;

c) a copy of the registering authority of permission to carry out clinical tests of the medical product;

d) the conclusions issued by an expert institution during the examination of the quality, efficiency and safety of the medical product;

e) copies of orders issued by the registering authority;

e) a copy of the registration certificate or notifications issued by the registering authority;

g) a copy of the duplicate of the registration certificate decorated by the registering authority.

Change information:

Subparagraph "B" changed from June 13, 2018 - Resolution of the Government of Russia of May 31, 2018 N 633

c) in relation to the person, in the name of which the registration certificate was issued, - full and (if there is) abbreviated name, including brand Name, legal form of a legal entity and address of its location or surname, name and (in case there is) patronymic, address of the place of residence of an individual entrepreneur;

Change information:

Subparagraph "G" was changed from June 13, 2018 - Decision of medical devices approved by the Ministry of Health of the Russian Federation;

57. The registering authority decides on the abolition of state registration of the medical product in the following cases:

a) submitting an applicant for the abolition of state registration of a medical product;

b) the court of decision on violation of the rights of copyright holder to the results intellectual activity and equalized means of individualization when contacting medical devices;

c) representation by the authorized government of the Russian Federation federal organ executive authority according to the results of the state control over the appeal of medical devices, information confirming the facts and circumstances, creating a threat to the life and health of citizens and medical workers in the use and operation of medical devices;

Change information:

Paragraph 57 is supplemented by subparagraph "G" from June 13, 2018 - Resolution of the Government of Russia of May 31, 2018 N 633

d) identifying the registering authority based on the results of state control over the appeal of medical devices of information in the documents contained in the registration dossier submitted by the applicant and influenced the results of the examination of the quality, efficiency and safety of the medical product;

Change information:

Paragraph 57 is supplemented by subparagraph "D" from June 13, 2018 - Resolution of the Government of Russia of May 31, 2018 N 633

e) receiving the registering authority of the expert institution that contained in state registry Tool, apparatus, device, equipment, material and other products according to its functional purpose and (or) The principle of operation cannot be applied for medical purposes and are not medical products. Such a conclusion is presented (sent) by an expert institution to the registering authority within 10 working days from the date of receipt to the expert institution of the corresponding task of the registering authority with the application of the registration dossier documents.

Registration certificates (RU) for medical products and techniques that are not valid, but decorated prior to the introduction of a new law should be replaced by documents on the form approved by the Federal Health Supervision Service (Roszdravnadzor).

To obtain a new document, state registration is not necessary. The document is issued after submitting an application to Roszdravnadzor. It must necessarily indicate all the information provided for by the legislation that entered into force. The application is seen within 30 days from the date of its submission.

If the statement is issued correctly, the applicant receives new documentFully repeating the previous one. It saves the same number, date, name of the legal entity and other information. The exact period of document design is not officially established.

Roszdravnadzor is also entitled to refuse the applicant to replace the registration certificate for one of the following reasons:

the data prescribed in the application does not comply with the information set out in the replacement document;
there are no compulsory information (on the appointment of goods in accordance with the nomenclature of the classification of medical products, about the place of its manufacture, etc.);
arrangement from the manufacturer, which allows to replace the registration certificate, is missing or framed in improperly.

Roszdravnadzor's refusal is made in the form of a letter that is sent to the applicant's address.

When you need a duplicate ru

To implement medical products, any manufacturer or distributor must have a registration certificate. If it was ruled or lost, it should contact Roszdravnadzor and request a copy of the document. It is not required to undergo a re-registration procedure.

To get the official duplicate, the applicant must be provided:

written statement;
a document confirming the successful conduct of testing of the medical product;
manual for the operation of goods;
technical conditions and other documentation similar to this;
original (if available and subject to reading).

A duplicate stamp is put on a new registration certificate, and the old ceases to have legal force By staging on it the corresponding mark.

If you need more detailed information about re-registration and receiving a registration certificate duplicate, then you can contact our experts who will hold detailed advice. We also help with duplicate.

Government of the Russian Federation

Decision

On approval of the rules of state registration of medical devices

Document with changes made by:
(Official Internet portal legal information www.pravo.gov.ru, 10/21/2013);
(Official Internet portal of legal information www.pravo.gov.ru, 07.21.2014);
(Official Internet portal of legal information www.pravo.gov.ru, 02/14/2017, N 0001201702140017);
(Official Internet portal of legal information www.pravo.gov.ru, 06/05/2018, N 0001201806050008).
____________________________________________________________________

In accordance with Article 38 of the Federal Law "On the Fundamentals of the Health of Citizens in the Russian Federation" Government of the Russian Federation

decides:

1. To approve the accompanying rules for state registration of medical devices.

2. Install that:

a) registration certificates for medical products and medical equipment with a fixed period of action issued until the day of entry into force of this Regulation are valid until the expiration of the validity period of the validity period;

b) Registration certificates for medical products and medical techniques of indefinite action, issued until the day of entry into force of this resolution, are valid and subject to replacement until January 1, 2021 for registration certificates in the form approved by the Federal Health Supervision Service.
Resolution of the Government of the Russian Federation of October 17, 2013 N 930; In the editorial office, conducted from February 22, 2017 by the Decree of the Government of the Russian Federation of February 10, 2017 N 160.

Replacing the registration certificate is carried out without passing the procedure of state registration of medical devices on the basis of the application submitted by the applicant in Federal Service on oversight in health care, indicating information provided for by the rulesapproved by this resolution.

3. State registration of medical devices submitted to state registration until the day of entry into force of this resolution is carried out on the basis of the documents submitted until the day of entry into force of this Regulation, as well as the statements about the state registration of the medical device submitted by the applicant in accordance with the rules approved This Resolution, to the Federal Health Supervision Service.

4. The implementation of the powers stipulated by this resolution is carried out within the limits established by the Government of the Russian Federation of the marginal number of employees of the Central Office of the Federal Health Supervision Service, as well as the budget allocations provided for by the service in federal budget For guidance and management in the field of established functions.

Chairman of the government
Russian Federation
D.Medvedev

Rules for state registration of medical devices

Approved
decree of Government
Russian Federation
dated December 27, 2012 N 1416

1. These Rules establish the procedure for state registration of medical devices to be applied to the territory of the Russian Federation.

2. Any tools, devices, apparatus, equipment, materials and other products used for medical purposes are subject to state registration separately or in combination with each other, as well as with other accessories necessary to apply these intended products, including special software, and intended by the manufacturer (manufacturer) for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body, medical research, restoration, replacement, changes in the anatomical structure or physiological functions of the body, preventing or interrupting pregnancy, the functional purpose of which is not implemented by Pharmacological, immunological, genetic or metabolic impact on the human body (hereinafter - medical products).
Resolution of the Government of the Russian Federation of July 17, 2014 N 670.

Medical products made according to individual orders of patients to which special requirements for the appointment of medical workers are presented and which are intended solely for personal use of a specific patient, state registration is not subject to.

3. State registration of medical devices is carried out by the Federal Health Supervision Service (hereinafter referred to as the registering authority).

4. These rules use the following basic concepts:

"Safety of the Medical Product" - the absence of an invalid risk of causing harm to life, human health and environment when using a medical product for purpose under the conditions provided by the manufacturer (manufacturer);
(Paragraph in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

"Quality of Medical Product" - a set of properties and characteristics of a medical product that affects its ability to act as appropriate, subject to compliance with the requirements of the regulatory documentation, technical and operational documentation of the manufacturer (manufacturer);
(Paragraphs in the editorial office entered into force from October 29, 2013 by the Decree of the Government of the Russian Federation of October 17, 2013 N 930 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

"Clinical trials" - a developed and planned systematic study taken by the participation of a person as a subject to assess the safety and effectiveness of the medical product;

"Regulatory documentation" - documents regulating safety requirements, quality, as well as the estimated effectiveness of the provided application and methods for monitoring the compliance of the medical product with these requirements;

"Registration Dossier" - a set of documents submitted for state registration, make changes to such documents, as well as copies of decisions adopted by the registering authority in relation to a particular medical product;
Decree of the Government of the Russian Federation of May 31, 2018 N 633.

"Manufacturer's technical documentation (manufacturer)" - Documents regulating the design of the medical device, establishing technical requirements and containing data for its development, production, application, operation, maintenance, repair, disposal or destruction;
(Paragraph in the editorial office entered into force from October 29, 2013 by the Decree of the Government of the Russian Federation of October 17, 2013 N 930; in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

"Technical Tests" - Tests in order to determine the conformity of the characteristics of the medical product, the requirements of the regulatory documentation, technical and operational documentation of the manufacturer (manufacturer) and making a subsequent decision on the possibility of clinical trials;
(Paragraph in the editorial office entered into force from October 29, 2013 by the Decree of the Government of the Russian Federation of October 17, 2013 N 930; in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

"Toxicological research" - Studies in order to assess the biological safety of the medical product and making a subsequent decision on the possibility of conducting clinical trials;

"authorised representative manufacturer (manufacturer) "- a legal entity or an individual entrepreneur registered in the territory of the Russian Federation authorized by the manufacturer (manufacturer) of a medical product to represent his interests on the appeal of a medical product in the Russian Federation, including on conformity assessment procedures and state registration, in the name of which a registration certificate may be issued;
(Paragraphs in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670 by Decree of the Government of the Russian Federation of May 31, 2018 N 633.

"Manufacturer's operational documentation (manufacturer)" - documents intended to familiarize consumer with the design of a medical product, regulating the conditions and rules of operation (use for intended, maintenance, maintenance, storage and transportation), guaranteed by the manufacturer (manufacturer) of the basic parameters, characteristics of the medical product, warranty obligations, as well as information about its disposal or destruction;
(Paragraph in the editorial office entered into force from October 29, 2013 by the Decree of the Government of the Russian Federation of October 17, 2013 N 930; in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

"The effectiveness of the medical product" is a set of properties and characteristics of a medical product that ensure the achievement of the purpose of the purpose established by the manufacturer (manufacturer) and confirmed by the practice of clinical use.
(Paragraph in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

5. State registration of medical devices is carried out on the basis of technical test results, toxicological studies, clinical trials, which are forms to assess the compliance of medical devices, taking into account the classification, depending on the potential risk of their application, and the examination of the quality, efficiency and safety of medical products, taking into account the classification in Depending on the potential risk of their application, as well as tests in order to approve the type of measuring instruments (in relation to medical devices related to the measurement tools in the field of state regulation of ensuring the unity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation).
(Paragraph in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

Ensuring the organization of work on the formation and maintenance of the nomenclature classification of medical products by types is carried out by the registering authority.
(Paragraph is additionally included since July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670)

With a change in the type of medical product, within the framework of work on the formation and maintenance of the nomenclature classification of medical devices by type approved by the Ministry of Health of the Russian Federation, the registering authority contributes to the register of the State Register of Medicines and Organizations (individual entrepreneurs), carrying out the production and manufacture of medical devices (hereinafter - State registry), a corresponding change and notifies a legal entity or an individual entrepreneur about this, in the name of which a registration certificate was issued for a medical product, which is changed, within 20 working days from the date of making a change in the registry registry.
Decree of the Government of the Russian Federation of May 31, 2018 N 633)

6. A document confirming the fact of state registration of a medical product is a medical certificate (hereinafter referred to as a registration certificate). The form of the registration certificate is approved by the registering authority.

Registration certificate is issued indefinitely.

7. The state duty is paid in accordance with the legislation of the Russian Federation on taxes and fees.

Information on the payment of state duty is requested by the registering authority in the order of inter-ministerial information cooperation in accordance with the Federal Law "On the organization of the provision of state and municipal services".

8. For state registration of the medical device, the developer, the manufacturer (manufacturer) of the medical product or the authorized representative of the manufacturer (manufacturer) (hereinafter - the applicant) submits or sends a statement of state registration of the medical product to the registering authority, as well as the documents specified in paragraph 10 of this Regulation .
Resolution of the Government of the Russian Federation of July 17, 2014 N 670.

9. In a statement of state registration of a medical device (hereinafter referred to as a statement of registration), the following information is indicated:

a) the name of the medical product (with an indication of the accessories necessary for the use of a medical product for its intended purpose), while the applicant indicates a trademark and other means of individualization of the medical product if they are applied to the packaging of the medical product;
Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Subparagraph "A" of paragraph 9 of this Regulation (as amended.
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b) in relation to the developer - full and (in case there is) abbreviated name, including branded name, organizational and legal form of a legal entity, address of its location or surname, name and (in case there is) patronymic, details a document certifying the identity, address of the residence of an individual entrepreneur, as well as telephone numbers and (if there is) an email address of a legal entity or an individual entrepreneur;
(Subparagraph in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Subparagraph "b" of paragraph 9 of these Rules (as amended by the Decree of the Government of the Russian Federation dated May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018 - paragraph 2 of the Government Decisions of the Russian Federation May 31, 2018 N 633.
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c) with respect to the manufacturer (manufacturer) of the medical product - complete and (if there is) abbreviated name, including branded name, organizational and legal form of a legal entity, address of the location or surname, name and (in case there is ) Patronymic, details of a document certifying the personality, address of the place of residence of an individual entrepreneur, as well as phone numbers and (in case there is) an email address of a legal entity or an individual entrepreneur;
Resolution of the Government of the Russian Federation of July 17, 2014 N 670.

d) in relation to the authorized representative of the manufacturer (manufacturer) - complete and (in case there is) abbreviated name, including branded name, organizational and legal form of a legal entity, address of its location or surname, name and (in case There is) patronymic, details of a document certifying the identity, address of the residence of an individual entrepreneur, as well as phone numbers and (if there is) an email address of a legal entity or an individual entrepreneur;
(Subparagraph in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Subparagraph "G" of paragraph 9 of these Rules (as amended by the Decree of the Government of the Russian Federation dated May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018 - paragraph 2 of the Government Decisions of the Russian Federation May 31, 2018 N 633.
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e) in relation to the person, in the name of which the registration certificate may be issued, - full and (if there is) a reduced name, including the proprietary name, organizational and legal form of a legal entity, address of his location or surname, name and (in case there is) patronymic, details of a document certifying the identity, address of the place of residence of an individual entrepreneur, as well as phone numbers and (in case there is) an email address of a legal entity or an individual entrepreneur;
(Subparagraph in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Subparagraph "D" of paragraph 9 of these Rules (as amended by the Decree of the Government of the Russian Federation dated May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices, which arose until June 13, 2018, paragraph 2 of the Government Decisions of the Russian Federation May 31, 2018 N 633.
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e) the place of production of the medical product;

g) appointment of a medical device installed by the manufacturer (manufacturer);
(Subparagraph in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

h) type of medical product in accordance with the nomenclature classification of medical devices;

and) the class of potential risk of using a medical product in accordance with the nomenclature classification of medical devices;

k) code;
Decree of the Government of the Russian Federation of February 10, 2017 N 160.

l) information about the method of obtaining a registration certificate, as well as information related to the procedure for state registration of a medical product.

10. The following documents are submitted for state registration of a medical device:

a) a copy of the document confirming the authority of the authorized representative of the manufacturer (manufacturer);
(Subparagraph in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

b) information about the regulatory documentation for the medical product;

c) Manufacturer's technical documentation (manufacturer) for a medical device;
Resolution of the Government of the Russian Federation of October 17, 2013 N 930; As amended, entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

d) the manufacturer's operational documentation (manufacturer) on the medical product, including instructions for use or the manual for the operation of the medical product;
(Subparagraph, as amended by the Decree of the Government of the Russian Federation of October 17, 2013, by Decree of the Government of the Russian Federation from July 29, 2014, the Decree of the Government of the Russian Federation of July 17, 2014 No. 670 from July 29, 2014.

e) photographic images of a general type of medical product together with accessories necessary for the use of a medical product for purpose (at least 18 x 24 centimeters size);
(Subparagraph in the editorial office entered into force from October 29, 2013 by the Decree of the Government of the Russian Federation of October 17, 2013 N 930.

(e) Documents confirming the results of technical testing of the medical product;

g) documents confirming the results of toxicological studies of the medical product, the use of which involves the presence of contact with the human body;

h) documents confirming the test results of a medical product testing to approve the type of measuring instruments (with respect to medical devices related to the means of measurement in the field of state regulation of ensuring the unity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);

and) inventory documents;

k) for medical devices 1 class of potential risk of application and medical devices for diagnostics in vitro - information confirming the clinical efficacy and safety of medical devices;
(Subparagraph in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Subparagraph "To" of paragraph 10 of these Rules (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018 - paragraph 2 of the Government Decisions of the Russian Federation May 31, 2018 N 633.
____________________________________________________________________

l) a draft plan of clinical testing of a medical product with substantive materials (in case there is);
(Subparagraph additionally included from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670)

m) information on the recording authorities issued by the registering authority for the importation of medical devices for the purpose of their state registration (for medical products of foreign production);
Decree of the Government of the Russian Federation of May 31, 2018 N 633)

____________________________________________________________________

Subparagraph "M" of clause 10 of these Rules (as amended by the Decree of the Government of the Russian Federation dated May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018 - paragraph 2 of the Government Decisions of the Russian Federation May 31, 2018 N 633.
____________________________________________________________________

n) copies of documents confirming the quality of the drug, pharmaceutical substance, biological material and other substances using the medical product or which are included in its composition and which are intended for use only taking into account the purpose of the medical product defined by the manufacturer, and issued in accordance with the legislation of the country of origin of the drug, pharmaceutical substance, biological material and other substances .
(Subparagraph additionally included from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633)

____________________________________________________________________

Subparagraph "H" of paragraph 10 of these Rules (as amended by the Decree of the Government of the Russian Federation dated May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018 - paragraph 2 of the Government Decisions of the Russian Federation May 31, 2018 N 633.
____________________________________________________________________

11. If the documents specified in paragraph 10 of these Rules are compiled in a foreign language, they are submitted to the translation certified in the prescribed manner.
(The point in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

12. Terms and sequence of administrative procedures and administrative action The registering authorities are established developed in accordance with the Decree of the Government of the Russian Federation of May 16, 2011 N 373 administrative regulations provision state services According to state registration of medical devices.

13. Application for registration and documents provided for in paragraph 10 of these Rules are submitted by the applicant to the registering authority on paper directly or are sent by custom mail with a notification of the presentation and the description of the investment either in electronic form signed by an electronic signature.

The registering authority accepts an application for registration and documents stipulated by clause 10 of these Rules, according to an inventory, a copy of which, with a mark on the date of reception of these applications and documents on the reception day, is awarded to the applicant or sent to him by registered mail with a notice of awarding or electronically by telecommunication Communication channels.
(Paragraph in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

16. If the registration application is issued in violation of the provisions of paragraph 9 of these Rules and (or) in the application, there are no documents provided for in paragraph 10 of these Rules, presented not in full, the registering authority presents the applicant notification of the need to eliminate 30 - Formerly deadlines for violations and (or) submission of documents that are missing, or directs such a notification by registered mail with a notification of the presentation or in the form of an electronic document signed by an electronic signature or in electronic form in telecommunication channels.

The notification in the case of its direction by registered mail is considered received after 10 working days from the date of the notification direction.
(Paragraph is additionally included since June 13, 2018 by Decree of the Government of the Russian Federation of May 31, 2018 N 633)
(The point in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

18. In the event that within 30 days, the identified violations and (or) are not presented documents that are missing, the registering authority decides on the return of registration and documents provided for in paragraph 10 of these Rules, with a motivated substantiation of the reasons for the return.

The deadline for clinical testing of the medical product in a 50-day term is not included.

20. Within 3 working days from the date of deciding on the start of state registration of medical devices, the registering authority issues and issues a task to conduct an examination of the quality, efficiency and safety of the medical device by the Federal State Budgetary Institution, which is carried out in the registering authority (hereinafter referred to as an expert institution).

a) at the stage of the registration statement of registration and documents specified in paragraph 10 of these Rules, to determine the possibility (inexpensability) of the clinical testing of the medical product (with the exception of medical products 1 of the potential risk of use and medical devices for diagnostics in vitro);
(Subparagraph in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

b) at stage II, an examination of the completeness and results of technical testing conducted, toxicological research, clinical trials, as well as tests in order to approve the type of measuring instruments (with respect to medical devices relating to measurement tools in the field of state regulation of ensuring the unity of measurements, the list of which is approved Ministry of Health of the Russian Federation) (hereinafter - the expertise of completeness and test results and research).

21_1. During the examination of the quality, efficiency and safety of the medical product (at any stage), the applicant's expert institution is not allowed to be applied by the applicant or other persons necessary for the examination.

In case of insufficiency, to make an expert in the conclusion of materials and information contained in the applicant submitted by the applicant on registration and documents provided for in paragraph 10 of these Rules, the expert puts the question of submitting the necessary materials and information to it before the head of the expertiary, which is drawn to the relevant request to the registering authority who issued a task for examination. The registering authority within 2 working days from the date of receipt of the request of the head of the expert institution sends a request to the applicant about the submission of the necessary information indicating the nature of the comments and the method of eliminating them. This request is sent once at each stage of the quality examination, efficiency and safety of the medical product and can be transferred to the authorized representative of the applicant personally for receipt, sent by registered mail with a notice of a presentation or transferred in electronic form to telecommunication channels or in the form of an electronic document signed electronic signature.
(Paragraph in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

The applicant is obliged to submit an answer to the request of the registering authority within a period not exceeding 50 working days from the date of receipt of this request. Within 2 working days from the date of receipt from the applicant, the response to the request the registering authority sends such an answer to the expert institution. In case of failure after 50 working days, the applicant's response to the request of the registering authority within 2 business days aims to the expert institution a notice of failure to submit an answer to the request of the registering authority to prepare the conclusion of an expert institution on the basis of documents available at its disposal.

From the date of the direction of the request of the registering authority, until the day of receiving an answer to a request or notification of failure to submit a response to a request, it is not taken into account when calculating the quality of the quality examination, efficiency and safety of the medical product.

In the event that the response to the request, as well as the documents attached to it, are compiled in a foreign language, they are submitted to the translation certified in the prescribed manner into Russian.
(Paragraph is additionally included since June 13, 2018 by Decree of the Government of the Russian Federation of May 31, 2018 N 633)

When identifying the registering authority in the applicant submitted in response to the request of documents of unreliable and (or) lack of data or documents, compiled or containing text in a foreign language without translation in the prescribed manner into Russian, the registering authority provides for 2 working days (sends to registered mail Departing with a notification of the presentation or in the form of an electronic document signed by an electronic signature or in electronic telecommunication channels) to the applicant's decision on the return of these documents with a motivated substantiation of the reasons for the return and the report on the possibility of re-submitted by the applicant before the expiration of 50 working days from the date of receipt Request for finalized documents. In case of failure to submit the applicant to the specified period of the requested materials and information of the quality examination, the effectiveness and safety of the medical product continues at the expert institution that has previously submitted to the applicant and information contained in the registration file.
(Paragraph is additionally included since June 13, 2018 by Decree of the Government of the Russian Federation of May 31, 2018 N 633)
Resolution of the Government of the Russian Federation of July 17, 2014 N 670)

23. The basis for an expert institution of concluding about the impossibility of clinical testing of the medical product or the impossibility of state registration of a medical product is:
(Paragraph in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

a) non-compliance of the medical product with the requirements of regulatory documentation, technical and (or) operational documentation of the manufacturer (manufacturer);
(Subparagraph, as amended by the Decree of the Government of the Russian Federation of October 17, 2013, by Decree of the Government of the Russian Federation from July 29, 2014, the Decree of the Government of the Russian Federation of July 17, 2014 No. 670 from July 29, 2014.

b) the lack of evidence of the security of the medical product.
(Subparagraph in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

(Subparagraph in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

26. Clinical tests of the medical product, with the exception of medical products 1 of the potential risk of application and medical devices for diagnostics in vitro, are carried out as part of an assessment of compliance, the order of which is approved by the Ministry of Health of the Russian Federation.
(Paragraph in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

The composition of the specified Council on Ethics and the Regulation on Him is approved by the Ministry of Health of the Russian Federation.

Clinical tests of the medical product are conducted in medical organizations that meet the requirements approved by the Ministry of Health of the Russian Federation. Conformity establishment medical organizations These requirements are carried out by the registering authority in the manner prescribed by the said ministry.

27. The list of medical organizations with the right to conduct clinical tests of medical devices, and the register of issued permits for clinical testing of medical devices is published and posted by the registering authority in the procedure established by it on their official website in the Internet information and telecommunication network.

28. When making a decision on issuing a permit for clinical testing of a medical device, the registering authority decides to suspend state registration of a medical device until the day of the decision of the registering authority on the resumption of state registration of the medical product, in accordance with paragraph 30 of these Rules.

29. On clinical trials of the medical product, the applicant notifies the registering authority within 5 working days from the beginning of their conduct.

30. At the end of the clinical testing of the medical device, the applicant submits a statement of the state registration of the medical product and the results of clinical testing of the medical product, as well as the documents specified in subparagraphs "B" - "s", "to" and "l" 10 of these Rules, in case there are changes in the results of clinical tests of the medical product.
(The point in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

31. The registering authority within 2 working days from the date of receipt of the documents specified in paragraph 30 of this Regulation decides on the resumption of state registration of the medical product.

The decision on the resumption of state registration of a medical product is made by the registering authority on the results of verification of the completeness and reliability of the information contained in the statement submitted to the registering authority on the resumption of state registration of medical products and other documents specified in paragraph 30 of this Regulation.

If these documents are not fully submitted or unreliable data is revealed, as well as in the case of submission of documents compiled in a foreign language, without the procedure for transferring a translation into Russian, the registering authority provides for the registering authority with the notification of Awarding or in the form of an electronic document signed by an electronic signature or in electronic telecommunication channels) to the applicant's decision on the return of the application for the resumption of state registration of a medical product with annex to it of these documents and the presentation of the reasons that served for such a return. At the same time, the registering authority informs the applicant about the possibility of re-submitting an application for the resumption of state registration of a medical product with an attachment to it revised documents.
Decree of the Government of the Russian Federation of May 31, 2018 N 633.

32. At the stage of the quality examination, the quality efficiency and safety of the medical device, the registering authority within 2 working days from the date of the decision to resume the state registration of the medical product on the basis of a task to conduct an examination of the quality, efficiency and safety of a medical product issued in accordance with paragraph 20 This Regulation sends to the expert institution submitted by the applicant the results of clinical tests of the medical product.

33. The expert institution within a period not exceeding 10 working days from the date of receipt of the documents specified in paragraph 32 of these Rules, conducts an examination of the completeness and results of the tests and research, and also issues and sends a conclusion to the registering authority according to the results of quality examination, efficiency and The security of the medical product, the form of which is approved by the Ministry of Health of the Russian Federation.

34. In a period not exceeding 10 working days from the date of receipt of the conclusion specified in paragraph 33 of this Regulation, the registering authority performs the following activities:

b) making a decision on state registration of a medical product or a refusal to state registration of a medical product, which is issued by the order of the registering authority, and notify the applicant about the decision taken;

c) registration and issuance (by registered mail with a notification of the presentation or in the form of an electronic document signed by electronic signature, or transfer to electronic telecommunication channels) to the applicant of the registration certificate or notification of refusal to state registration of a medical device indicating the reasons for refusal .
(Subparagraph in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

35. The grounds for the adoption by the registering authority of the decision to refuse the state registration of the medical product are:

a) obtaining from an expert institution of imprisonment according to the results of examination of the quality, efficacy and safety of a medical device, indicating that the quality, and (or) efficiency, and (or) the safety of the registered medical device is not confirmed by the data and (or) about that the risk of harm to the health of citizens and medical workers due to the use of a medical product exceeds the effectiveness of its use;

b) identifying the registering authority based on the results of state control over the appeal of medical devices for the inconsistencies of data on efficiency and the safety of medical product information contained in the registration application and documents specified in paragraph 10 of these Rules.
(The point in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

36. Within 1 working day, after making a decision on state registration of a medical device, the registering authority makes data on a registered medical product in the state register in the manner prescribed by the Government of the Russian Federation of June 19, 2012 N 615.
(The point in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670; as amended, entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

37. To changes that contribute to the documents contained in the registration dossier, which do not require the examination of the quality, efficiency and safety of the medical product include:

a) change the applicant information, including information:

on changing the name of the legal entity (full and (in case there is) abbreviated, including branded name), addresses of its location;

about changing the surname, name and (if there is) patronymic, addresses of the place of residence of the individual entrepreneur and details of the document certifying his identity;

b) Changing the information about the face, in the name of which a registration certificate may be issued, including information:

on the reorganization of a legal entity;

c) change the address of the production site (manufacturing) of the medical product;

adding (exclusion) of the accessories of a medical product or a change in their name;

indication, change and exclusion of trademark and other means of individualization of the medical product;

a change in the number of units of the medical product or its component parts, components specified in the application to the registration certificate;

specifying or eliminating the options (models) of the medical product;

changing marking and (or) packaging of the medical product;

e) a change in the manufacturer (manufacturer) of the medical device for the validity of the documents contained in the registration dossier;

(e) Changing information about the authorized representative of the manufacturer (manufacturer) of the medical product.
(The point in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Paragraph 37 of this Regulation (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018, paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

a) an application for amending the documents contained in the registration dossier (hereinafter referred to as amending the amendments), issued in accordance with paragraph 9 of these Rules;

b) a copy of the document confirming the authority of the authorized representative of the manufacturer (manufacturer);

information about the regulatory documentation for the medical product;

technical documentation of the manufacturer (manufacturer) on the medical product, summarized with the new name of the medical product;

photographic images of the general form of a medical device together with accessories necessary for the use of a medical product for purpose (at least 18 centimeters size in length and 24 centimeters in width);

e) the original registration certificate (duplicate);

e) Inventory documents.
(The point in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Paragraph 38 of this Regulation (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) is not applied to legal relations related to the implementation of state registration of medical devices, which arose until June 13, 2018 - paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

____________________________________________________________________

Paragraph 39 of this Regulation (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018 - paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

40. In the event that the documents stipulated by paragraph 38 of these Rules are compiled in a foreign language, they are submitted to the translation certified in the prescribed manner.
(The point in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670; as amended, entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Item 40 of this Regulation (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018, paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

41. An application for amending and documents stipulated by paragraph 38 of these Rules is made by the registering authority for inventory, a copy of which, with a mark on the date of reception of these applications and documents on the reception day, is awarded to the applicant or sent to him by registered mail with a notice of a presentation or in the form Electronic document signed by electronic signature or in electronic form in telecommunication channels.
(The point in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670; as amended, entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Paragraph 41 of this Regulation (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018, paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

42. The registering authority is not entitled to require the applicant to submit documents not provided for in paragraph 38 of these Rules.
(The point in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Paragraph 42 of this Regulation (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical products that have arisen until June 13, 2018 - paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

43. Within 5 working days from the date of receipt of the application for amending and documents stipulated by paragraph 38 of this Regulation, the registering authority checks the completeness and reliability of the information contained in them, including by comparing such information provided in accordance with the procedure for interdepartmental information interaction.
(The point in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670; as amended, entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Paragraph 43 of this Regulation (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018, paragraph 2 of the Government of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

____________________________________________________________________

Paragraph 44 of these Rules (as amended by the Decree of the Government of the Russian Federation dated May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018 - paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

____________________________________________________________________

Paragraph 45 of this Regulation (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices, which arose until June 13, 2018, paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

46. \u200b\u200bIf within 30 days, the identified violations and (or) are not presented documents that are missing, the registering authority decides on the return of the application for amending and the documents stipulated by paragraph 38 of these Rules, with a motivated substantiation of the reasons for the return.
(The point in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Item 46 of this Regulation (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices, which have arisen until June 13, 2018, paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

____________________________________________________________________

Paragraph 47 of these Rules (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018, paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

48. The term of adoption by the registering authority of the decision on amending the documents contained in the registration file is calculated from the date of receipt of the registering authority with a properly executed application for amending and in full documents provided for in paragraph 38 of these Rules.
(The point in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Paragraph 48 of these Rules (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018 - paragraph 2 of the Government of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

49. When making changes to the documents contained in the registration dossier, the registering authority performs the following activities:

a) making a decision on amending the documents contained in the registration dossier, which is issued by the order of the registering authority;

____________________________________________________________________

Clause 49 of these Rules (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices, which have arisen until June 13, 2018, paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

49_1. The grounds for making an expert establishment of the impossibility of making changes to the documents provided for by subparagraphs "in" and "g" of paragraph 10 of these Rules are:

a) the unreliability of the presented information substantiating changes, including those identified by the registering authority on the results of state control over the appeal of medical devices;

____________________________________________________________________

Paragraph 49_1 of this Regulation (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018 - paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

49_2. The registering authority within 2 working days from the date of obtaining the conclusion of the expert institution decides on the possibility (inexpensability) of making changes to the documents contained in the registration file, and notifies the applicant's adopted decision by registered mail with the notice of a presentation or in the form of an electronic document signed electronic signature, or in electronic form in telecommunication channels.

____________________________________________________________________

Paragraph 49_2 of these Rules (as amended by the Decree of the Government of the Russian Federation of May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018 - paragraph 2 of the Government Decisions of the Russian Federation of May 31, 2018 year N 633.
____________________________________________________________________

50. The item has lost strength from June 13, 2018 - ..

51. Within 1 working day, after making a decision on amending the documents contained in the registration file, the relevant information is entered into the state register in the manner prescribed by the Government of the Russian Federation of June 19, 2012 N 615.
(The point in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670; as amended, entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

52. In the event of the loss of the registration certificate or its damage, the applicant has the right to contact the registering authority with a statement on the provision of a duplicate of the registration certificate (hereinafter referred to as a statement about the provision of duplicate).

In the event of a registration certificate of the application for the provision of duplicate, a spoiled registration certificate is attached.

53. Within 7 working days from the date of receipt of the documents specified in paragraph 52 of these Rules, the registering authority draws up a duplicate registration certificate on the registration certificate lettering with the "Duplicate" and the original registration certificate is recognized as invalid "and presents such a duplicate to the applicant or sends it By registered mail with a receipt notice.
(The point in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670.

54. The registering authority generates a registration file from the following documents:

a) application for registration and documents stipulated by clause 10 of these Rules, an application for the resumption of state registration of medical products, requests and documents provided for in paragraphs 21_1 and 30 of these Rules, an application for amending and documents provided for in paragraph 38 of this Regulation, as well as a statement on the provision of duplicate;
(Subparagraph in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation dated July 17, 2014 N 670; in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

b) a copy of the task to carry out the examination of the quality, efficacy and safety of a medical device, designed by the registering authority;

c) a copy of the registering authority of permission to carry out clinical tests of the medical product;

d) the conclusions issued by an expert institution during the examination of the quality, efficiency and safety of the medical product;

e) copies of orders issued by the registering authority;

e) a copy of the registration certificate or notifications issued by the registering authority;

g) a copy of the duplicate of the registration certificate decorated by the registering authority.

55. The item has failed from June 13, 2018 - the Decree of the Government of the Russian Federation of May 31, 2018 N 633 ..

55_1. The grounds for making an expert establishment of the impossibility of making changes to the documents provided for by subparagraphs "in" and "g" of paragraph 10 of these Rules are:

a) the unreliability of the presented information substantiating changes;

b) the lack of information confirming the invariability of the functional purpose and (or) the principle of the medical product, due to the introduction of changes in the documentation.
(Item is additionally included since July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670)

55_2. The paragraph has lost its strength from June 13, 2018 - Resolution of the Government of the Russian Federation of May 31, 2018 N 633 ..

The paragraph has lost its strength from June 13, 2018 - Resolution of the Government of the Russian Federation of May 31, 2018 N 633 ..

The register of the registration file is carried out by the registering authority in the manner prescribed by the legislation of the Russian Federation on archival business.
(Item is additionally included since July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670)

56. The following information is indicated in the registration certificate:

a) the name of the medical product (indicating the accessories necessary for the use of a medical product for the purpose);

b) the date of state registration of the medical device and its registration number;

c) in relation to the person, in the name of which the registration certificate was issued, - full and (if there is) a reduced name, including the proprietary name, organizational and legal form of a legal entity and the address of its location or surname, name and (in case, if any) patronymic, address of the place of residence of an individual entrepreneur;
(Subparagraph in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Subparagraph "in" of paragraph 56 of these Rules (as amended by the Decree of the Government of the Russian Federation dated May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018, paragraph 2 of the Government Decisions of the Russian Federation May 31, 2018 N 633.
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d) against the manufacturer (manufacturer) - full and (if there is) abbreviated name, including branded name, organizational and legal form and address of the location or surname, name and (in case there is) patronymic, address place of residence of an individual entrepreneur;
(Subparagraph in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation dated July 17, 2014 N 670; in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

____________________________________________________________________

Subparagraph "G" of paragraph 56 of this Regulation (as amended by the Decree of the Government of the Russian Federation dated May 31, 2018, N 633) does not apply to legal relations related to the implementation of state registration of medical devices that have arisen until June 13, 2018, paragraph 2 of the Government Decisions of the Russian Federation May 31, 2018 N 633.
____________________________________________________________________

e) the place of production of the medical product;

e) registration dossier number;

g) subparagraph has lost strength from June 13, 2018 - Resolution of the Government of the Russian Federation of May 31, 2018 N 633;

h) the class of potential risk of using a medical product in accordance with the nomenclature classification of medical products approved by the Ministry of Health of the Russian Federation;

and) the code of the all-Russian classifier of products by type of economic activity.
(Subparagraph in the editorial office conducted from February 22, 2017 by the Decree of the Government of the Russian Federation of February 10, 2017 N 160.

57. The registering authority decides on the abolition of state registration of the medical product in the following cases:

a) submitting an applicant for the abolition of state registration of a medical product;

b) the court decision on the violation of the rights of the copyright holder to the results of intellectual activity and the means of individualization in the appeal of medical devices;

c) submission by the authorized government of the Russian Federation by the federal executive body based on the results of the state control over the appeal of medical devices, information confirming the facts and circumstances, creating a threat to the life and health of citizens and medical workers in the use and operation of medical devices;

e) obtaining the registering authority of the expert institution's conclusions that the tool, apparatus, apparatus, equipment, material and other products in its functional purpose contained in the state register in their functional purpose and (or) the principle of operation cannot be applied for medical purposes and are not medical products. Such a conclusion is presented (sent) by an expert institution to the registering authority within 10 working days from the date of receipt to the expert institution of the corresponding task of the registering authority with the application of the registration dossier documents.
(Subparagraph additionally included from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633)

58. The registering authority places information related to the implementation of state registration of a medical device, amending the documents contained in the registration file, and issuing a duplicate registration certificate, on its official website in the information telecommunications network "Internet".
(The point in the editorial office entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

58_1. The expert institution provides consulting on procedures related to state registration of medical devices, in the manner prescribed by the registering authority.
(Item is additionally included since February 22, 2017 by the Decree of the Government of the Russian Federation of February 10, 2017 N 160)

59. Decisions and actions (inaction) of the registering authority, which caused a violation of the rights of a legal entity, an individual entrepreneur, as well as the conclusion of an expert institution on the results of the examinations conducted by him in accordance with these Rules may be appealed to the applicant in the manner prescribed by the legislation of the Russian Federation.
(The point in the editorial office entered into force from July 29, 2014 by the Decree of the Government of the Russian Federation of July 17, 2014 N 670; as amended, entered into force from June 13, 2018 by the Decree of the Government of the Russian Federation of May 31, 2018 N 633.

Editorial Document Taking into account
changes and additions prepared
JSC "Codex"

The deadline for replacing registration certificates (RU) on medical products and medical technique Extended until January 1, 2017.

The form of an application for replacing the registration certificate appeared on your site. Explain what documents need to be applied to the application for replacing the registration certificate?

Replacing the registration certificate is carried out only on the basis of a statement submitted by the applicant to the Federal Health Supervision Service, indicating the information provided for by the rules of state registration of medical devices, approved by the Decree of the Government of the Russian Federation of 27.12.2012 N 1416. No additional documents Not required.

Form of statement on state registration of a medical product / on amending the registration certificate / on the replacement of a registration certificate for a medical device (16,2Kb)

Where to view information on the course of consideration of documents for registration of medical devices?

Find out the course of the review of documents on the registration of products, you can the Federal Service for Supervision of Health

On the extension of the replacement of registration certificates before January 1, 2021

Decree of the Government of the Russian Federation dated February 10, 2017 No. 160 "On Amendments to the Resolution of the Government of the Russian Federation of December 27, 2012 No. 1416" was made amendments to the Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 "On approving state rules registration of medical devices "

Changes touched, including extension of the replacement of registration certificates before January 1, 2021

The changes made are not global, but it is worth paying attention to the fact that it is now necessary to specify the product code in the OKPD2 classification!

RESOLUTION of PP1416_100217.pdf (42Kb)

The lists of the information to be specified in the technical and operational documentation of the manufacturer (manufacturer) of the medical product are identified

Order of the Ministry of Health of Russia dated January 19, 2017 N 11n "On approval of the requirements for the maintenance of the manufacturer's technical and operational documentation (manufacturer) of the medical product"

The list of information that should contain the technical documentation of the manufacturer (manufacturer) to the medical product, represented in the registration dossier on the medical product, includes, in particular, information on potential consumers of the medical product; information on verification and validation of the medical product, which were used to proof the compliance of the medical device established; Information on tests conducted, test protocols, analysis of data and other information. Additional requirements Installed for technical documentation Medical product for diagnostics in vitro.

The information included in the manufacturer's operational documentation (manufacturer) to the medical product is specifications products; the frequency of maintenance, including the assessment and disinfection of the medical product; Procedure for processing a medical product for its reuse, including cleaning, disinfection, packaging and, if necessary, the re-sterilization method, as well as the criteria for the unsuitability of the medical product for use. For operational documentation of the medical product for diagnostics in Vitro also establishes an extended list of requirements.

Approved requirements apply to the technical and operational documentation of manufacturers (manufacturers) of medical devices, statements on state registration of which are presented in Rossnadzor after its entry into force.

How much is the replacement of the registration certificate?

Currently, the replacement of the registration certificate is made free. Tax Code Russian Federation national tax For the replacement of the registration certificate is not provided.

How time from the date of application is replaced by a registration certificate?

Decree of the Government of the Russian Federation of the Government of the Russian Federation of 27.12.2012 No. 1416 did not establish time for replacing registration certificates. Replacement statements are discussed within the deadlines established for consideration of appeals - 30 days from the date of receipt of the application to Roszdravnadzor.

In a registration certificate issued by our company, its validity period "until July 15, 2013" is specified. Can we put a replacement application before this deadline and get a new registration certificate?

No you can not. IN this case According to "urgent" registration certificates (i.e. issued with the indication of the term) replacing the "old" registration on "new" in accordance with the Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 not produced. The registration certificate issued to you is valid until the expiration of the term specified in it. After that, you can contact Roszdravnadzor with a statement about registration of a medical product and go through the registration procedure in general.

If the period of the registration certificate has already expired, can we apply for re-registration and get a new registration certificate?

Decree of the Government of the Russian Federation dated December 27, 2012 No. 1416 does not provide for the "re-registration" procedure. In the event that the term of the registration certificate has expired, the applicant appeals to Roszdravnadzor with a statement on the registration of a medical product and passes the entire registration procedure in general.

Get acquainted with the technical regulations of the Customs Union 032/2013 on the safety of excess pressure equipment (448 Kb)

Will there be preserved numbers and dates of issued registration certificates?

Yes, when replacing registration certificates, the number and the date specified in the previously issued certificate is preserved.

What registration certificates are subject to replacement?

In accordance with paragraph 2 of the Decree of the Government of the Russian Federation No. 1416 dated December 27, 2012. "On approval of the rules of state registration of medical devices", registration certificates issued before January 1, 2013 are subject to a new sample certificate, which are not specified (so-called "indefinite" certificates).

How does the registration certificate be replaced?

The applicant issues the statement of the established sample. The form of the application is posted on the official website of Roszdravnadzor (it is necessary to open the sections "Medical products", "Registration of medical devices", "Forms of documents", "The form of an application for the replacement of a registration certificate for a medical device"). The application is submitted to Roszdravnadzor or by sending by mail, or gives up directly to the document management department and archive (Slavic Square, D.4, p. 1).
If the application is filled correctly (namely, all the necessary sections are filled, there are no changes), an employee of Roszdravnadzor transfers from the "old" registration certificate to the relevant sections of the "new" unchanged the following information:

number and date of the previously issued registration certificate;
the name of the legal entity, in the name of which is issued a registration certificate and its address;
name of the medical product;
the name of the manufacturer and its address;
potential risk class;
number and date of registration documentation set (in new form This information is entered into the section "The corresponding registration file No. ____, from _________");
the number and date of the order of Roszdravnadzor, in accordance with which the "old registration certificate" was issued).

And also additionally fills another new section:

the place of production of the medical product.

After signing the order for replacing the registration certificate, its number and date is also entered into a registration certificate.
The signed registration certificate is issued to the applicant. If in a statement in the section "Information about the method of obtaining a registration certificate" it is indicated "to issue a disregard by proxy", the authorized representative of the applicant by proxy receives the document in the department of document management and the archive of Roszdravnadzor at the address: Slavic Square, d.4, p. 1. If you want to "send by mail", the document goes to the applicant's address by registered letter with a notice of delivery.

How to replace a spoiled registration certificate?

If the registration certificate is ruled, you are entitled to contact Roszdravnadzor with a statement about issuing a registration certificate duplicate. The application must be attached to a spoiled registration certificate. On a new registration certificate will be the "Duplicate" mark, and the old one is repaid by stamping on it the corresponding stamp.

If the registration certificate is lost, how can it be restored?

In case of loss of the registration certificate, you are entitled to contact Roszdravnadzor with a statement about issuing a registration certificate duplicate.

Exchange of registration certificates in Roszdravnadzor

The exchange of the registration certificate is carried out without passing the procedure for state registration of medical devices on the basis of an application submitted by the applicant to the Federal Health Supervision Service, with the indication of the information provided for by the rules approved by this Resolution.

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On approval of the rules of state registration of medical devices. Procedure for re-registration of medical devices Replacement of a form of a registration certificate for a medical

The Ministry of Health went to meet manufacturers who declared the impossibility of getting new ru on time.

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When you need a duplicate ru

Rules for state registration of medical devices

The form of an application for replacing the registration certificate appeared on your site. Explain what documents need to be applied to the application for replacing the registration certificate?

Where to view information on the course of consideration of documents for registration of medical devices?

On the extension of the replacement of registration certificates before January 1, 2021

How much is the replacement of the registration certificate?

How time from the date of application is replaced by a registration certificate?

In a registration certificate issued by our company, its validity period "until July 15, 2013" is specified. Can we put a replacement application before this deadline and get a new registration certificate?

If the period of the registration certificate has already expired, can we apply for re-registration and get a new registration certificate?

Will there be preserved numbers and dates of issued registration certificates?

What registration certificates are subject to replacement?

How does the registration certificate be replaced?

How to replace a spoiled registration certificate?

If the registration certificate is lost, how can it be restored?

Exchange of registration certificates in Roszdravnadzor