Assistance in registration of medical devices of domestic and foreign production. From free initial consultation to receiving and transferring the registration certificate to the customer.

What is included in the concept of "medical devices" and why registration is needed

According to Article 38 Federal law from 21.11.2011 N 323-FZ (as amended on 03.07.2016) "On the basics of protecting the health of citizens in Russian Federation»Medical products include materials, apparatuses, equipment, tools, devices, together with accessories for their use for specialized purposes and other products, including specialized software, for use in medical purposes, namely:

• conducting diagnostic examinations;
• implementation of preventive, therapeutic, rehabilitation measures;
• termination / prevention of pregnancy;
• monitoring the functional state of the human body, as well as changes, restoration, replacement of its physiological functions or anatomical structure;
• medical research.

At the same time, the functional purpose of the products subject to registration should not provide for the impact on the human body by metabolic, pharmacological, genetic, immunological methods.

Depending on the level of the perceived potential risk of using medical devices, they are divided into four classes (1 - low, 2a - medium, 2b - increased, 3 - high). Classification by types of medical devices is carried out in accordance with the nomenclature approved by the Order of the Ministry of Health of Russia No. 4n dated 06.06.2012.

DRAW YOUR ATTENTION TO! In the Russian Federation, the sphere of circulation of medical devices, along with other types of activities in the field of health care, is subject to strict control by the state. Responsibility for the production of medical devices without a Roszdravnadzor license is determined by Article 235.1 of the Criminal Code of the Russian Federation, which provides for a fine of 500 thousand to 3 million rubles and imprisonment of the perpetrators for a period of 3 to 8 years, depending on the severity of the offense. A prerequisite for obtaining the desired permitting document- availability of a registration certificate for a medical device.

Administrative Regulations and Rules state registration medical devices were approved by Order of the Ministry of Health No. 737n of October 14, 2013 and Resolution of the Government of the Russian Federation No. 1416 of December 27, 2012 (as amended by Resolution of the Government of the Russian Federation No. 670 of July 17, 2014), respectively.

When state registration of medical devices is not required

The legislation allows the production of medical devices without going through the registration procedure in the case when they are manufactured according to the received from a specific patient individual order and will be used exclusively by the customer.

Self-registration of medical devices: difficulties and problems

The procedure for issuing a certificate for medical devices involves several stages. You will need:

• prepare a registration dossier;
• obtain permission from Roszdravnadzor to import samples (if it is necessary to register a foreign-made medical device);
• to confirm the quality and safety of products - for this purpose, an examination of quality compliance with regulatory requirements, toxicological studies, clinical and technical tests are carried out, taking into account the classification of products submitted for registration;
• take over the interaction with the registering authority at the stage of transferring the generated package of documents and passing the check.

At the same time, in order to achieve a positive result, it is necessary to constantly monitor the situation, relying on knowledge of legislative and regulatory requirements, in which many "pitfalls" are hidden, and to have experience in obtaining permits.

As part of the medical device registration service, you will be provided with:

• consulting and legal support on all issues of the registration procedure;
• assistance in obtaining a permit for the import of samples of a foreign manufacturing company;
• assistance in the formation of a dossier for filing an application for registration (we will determine the type of medical device in accordance with the classification nomenclature, we will develop technical specifications and assess the compliance of the existing technical documentation);
• assistance in organizing testing and research;
• services to support the registration process with Roszdravnadzor.

A complete list of documents for concluding a test contract is provided after receiving information about which product needs to be registered.

The cost of registration of medical devices

The price of the service is determined taking into account the number of tests that need to be carried out (depends on the risk class of the registered medical device).

Payment options

• Prolongation (payment by installments).
• Payment in installments - first payment of 50%.

In case of default on obligations - a refund on the next business day. There has never been a refusal to issue permits in our practice, therefore LLC "CPBO" Expert " can afford to prescribe this condition.

For the formation of an individual commercial offer, please send an e-mail [email protected] website:

• A brief description of the product with an indication of the composition of the materials from which the product is made and its purpose.
• Information about the manufacturer (name, country, already received certificates and other permits documents).

Registration certificate for medical devices - who issues, validity and receipt

LLC "CPBO" Expert " does not use dubious intermediaries. The electronic search service on the official website of Roszdravnadzor ( State Register medical devices and organizations / individual entrepreneurs engaged in the production and manufacture of medical devices). In accordance with the Administrative Regulations, information in the database on registered medical devices is entered into the database within one day after the authorized body made a decision on state registration.

Why is it beneficial for you to register a medical device with support LLC "CPBO" Expert "

• We interact with the registration authority and organizations that have the right to conduct research on samples of medical devices directly - the customer does not bear additional costs for intermediary services.
• For those who are just starting out, LLC "CPBO" Expert " provides a quick start - we will register a company / individual entrepreneur, we will select premises in accordance with the direction of work, we will assist in resolving the issue of equipment rental.
• If it becomes necessary to replace the registration certificate in connection with the introduction of changes, you have the opportunity to receive a discount on the service provided.
• You comprehensively solve the set task of business development in this field of activity - we will help,

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

Information about changes:

The registering authority accepts the application for registration and the documents provided for in paragraph 10 of these Rules, according to the inventory, a copy of which, with a note on the date of receipt of the specified application and documents on the day of acceptance, is handed to the applicant or sent to him by registered mail with acknowledgment of receipt or in electronic form through telecommunication communication channels.

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

15. Within 5 working days from the date of receipt of the application for registration and the documents provided for in paragraph 10 of these Rules, the registering authority checks the completeness and reliability of the information contained therein, including by comparing such information with information provided in the order of interdepartmental information interaction ...

16. If the application for registration is executed in violation of the provisions of clause 9 of these Rules and (or) the application contains inaccurate information or the documents provided for in clause 10 of these Rules are not submitted in full, the registering authority gives the applicant a notice of the need to eliminate in 30 -day period of revealed violations and (or) the submission of documents that are absent, or sends such a notification by registered mail with a receipt acknowledgment or in the form of an electronic document signed with an electronic signature

Notification, if sent by registered mail, is considered received after 10 working days from the date of sending the notification.

17. Within 3 working days from the date of submission of a duly executed application for registration and in full the documents provided for in paragraph 10 of these Rules, as well as in the case of elimination within 30 days of identified violations and (or) submission of documents provided for in paragraph 10 of these Rules, the registering body decides on the beginning of state registration of medical devices.

18. If the identified violations are not eliminated within 30 days and (or) documents that are missing are not submitted, the registering authority decides to return the application for registration and the documents provided for in paragraph 10

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

The period for conducting clinical trials of a medical device is not included in the 50-day period.

20. Within 3 working days from the date of the decision to start state registration of medical devices, the registering authority draws up and issues a task to conduct an examination of the quality, effectiveness and safety of a medical device to the federal state budgetary institution under the jurisdiction of the registering body (hereinafter - the expert institution).

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

a) at stage I, an examination of the application for registration and the documents specified in paragraph 10 of these Rules is carried out to determine the possibility (impossibility) of conducting clinical trials of a medical device (except for medical devices of the 1st class of potential risk of use and medical devices for in vitro diagnostics);

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

21.1. When conducting an examination of the quality, effectiveness and safety of a medical device (at any stage), it is not allowed for the expert institution to demand from the applicant or other persons the materials necessary for the examination.

If the materials and information contained in the application for registration and documents provided by the applicant for registration and documents provided for by paragraph 10 of these Rules are insufficient for the expert to make an opinion, the expert raises the question of providing him with the necessary materials and information to the head of the expert institution, who makes a corresponding request to the registration authority , who issued the task for the examination. The registering body, within 2 working days from the date of receipt of the request from the head of the expert institution, sends the applicant a request to provide the necessary information, indicating the nature of the comments and the way to eliminate them. The specified request is sent once at each stage of the examination of the quality, effectiveness and safety of the medical device and can be handed over to the authorized representative of the applicant personally against receipt, sent by registered mail with acknowledgment of receipt, or transmitted electronically via telecommunication channels or in the form of an electronic document signed electronic signature.

The applicant is obliged to submit a response 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 of a response to the request, the registering authority sends such a response to the expert institution. If the applicant fails to provide a response to the request after 50 working days, the registering authority shall, within 2 working days, send a notification to the expert institution that the applicant has not provided a response to the request of the registering body to prepare an opinion of the expert institution based on the documents at its disposal.

The time from the date of sending the request to the registering authority until the day of receiving a response to the request or notification of failure to provide a response to the request is not taken into account when calculating the period for the examination of the quality, efficacy and safety of a medical device.

If the answer to the request, as well as the documents attached to it, are drawn up in a foreign language, they are submitted with a duly certified translation into Russian.

If the registering authority reveals in the documents submitted by the applicant in response to a request for inaccurate and (or) insufficient data or documents drawn up or containing text in a foreign language without translation into Russian in accordance with the established procedure, the registering authority shall, within 2 working days, deliver (send by registered mail by sending with a return receipt or in the form of an electronic document signed with an electronic signature, or in electronic form via telecommunication channels) to the applicant a decision to return these documents with a reasoned justification of the reasons for the return and a message about the possibility of re-submission by the applicant before the expiration of 50 working days from the date of receipt requesting revised documents. If the applicant fails to submit the requested materials and information within the specified time period, the examination of the quality, effectiveness and safety of the medical device continues according to the documents and information contained in the registration dossier previously submitted by the applicant, at the disposal of the expert institution.

22. At the first stage of the examination of the quality, effectiveness and safety of a medical device, the expert institution, within a period not exceeding 20 working days from the date of receipt of the assignment, carries out the following activities:

a) examination of the application for registration and the documents provided for in paragraph 10 of these Rules to determine the possibility (impossibility) of conducting clinical trials of a medical device;

b) drawing up and sending to the registering authority an opinion on the possibility (impossibility) of conducting clinical trials of a medical device (indicating the reasons and justification for the impossibility of their conduct), the form of which is approved by the Ministry of Health of the Russian Federation.

23. The basis for an expert institution to issue a conclusion on the impossibility of conducting clinical trials of a medical device or the impossibility of state registration of a medical device is:

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

b) lack of evidence of the safety of the medical device.

24. The registering body, within 5 working days from the date of receipt from the expert institution of the opinion on the possibility (impossibility) of conducting clinical trials of a medical device, shall carry out the following measures:

a) assessment of the conclusion to determine compliance with the task for the examination of the quality, effectiveness and safety of a medical device. If it is established that the conclusion of the expert institution does not correspond to the specified task, such a conclusion is returned to the expert institution for revision, the period of which is no more than 2 working days from the date of receipt of the returned opinion by the expert institution;

b) making a decision to issue a permit to conduct clinical trials of a medical device or to refuse state registration of a medical device, which is formalized by an order of the registering authority, and notifying the applicant of the decision;

c) issuance (sending by registered mail with acknowledgment of receipt or in the form of an electronic document signed with an electronic signature) to the applicant of a permit to conduct clinical trials of a medical device, the form of which is approved by the registering authority, and entering the relevant information into the register of issued permits for conducting clinical trials of a medical products, the maintenance procedure of which is approved by the registering authority, or a notification of the refusal of state registration of a medical device with an indication of the reasons for the refusal.

25. The basis for making a decision to refuse state registration is the receipt by the registering authority from an expert institution of an opinion on the impossibility of conducting clinical trials of a medical device.

26. Clinical trials of a medical device, with the exception of medical devices of the 1st class of potential risk of use and medical devices for in vitro diagnostics, are carried out within the framework of conformity assessment, the procedure for which is approved by the Ministry of Health of the Russian Federation.

Clinical trials of a medical device, with the exception of medical devices of the 1st class of potential risk of use and medical devices for in vitro diagnostics, are carried out on the basis of a permit for conducting clinical trials issued by the registering authority, as well as an opinion on the ethical justification of clinical trials issued by the Ethics Council of the Ministry health care of the Russian Federation, in the cases established by the specified Rules.

37. Changes made to the documents contained in the registration dossier that do not require an examination of the quality, effectiveness and safety of a medical device include:

a) change in information about the applicant, including information:

about name change legal entity(full and (if any) abbreviated, including the company name), the address of its location;

about changing the last name, first name and (if any) patronymic, address of the place of residence individual entrepreneur and details of the document proving his identity;

b) change in information about the person in whose name a registration certificate for a medical device can be issued, including information:

on the reorganization of a legal entity;

on changing the name of a legal entity (full and (if any) abbreviated, including the company name), address of its location or last name, first name and (if any) patronymic, place of residence of an individual entrepreneur;

c) change of the address of the place of manufacture (manufacture) of a medical device;

d) changing the name of the medical device if the properties and characteristics that affect the quality, effectiveness and safety of the medical device have not changed, or its properties and characteristics are improved while the functional purpose and (or) the principle of operation remains unchanged, providing:

adding (excluding) medical device accessories or changing their name;

indication, change and exclusion of a trademark and other means of individualization of a medical device;

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

indication or exclusion of versions (models) of a medical device;

changing the labeling and (or) packaging of a medical device;

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

f) change of information about the authorized representative of the manufacturer (manufacturer) of the medical device.

Information about changes:

Clause 38 amended from 13 June 2018 - Ordinance

38. To make the changes specified in paragraph 37 of these Rules to the documents contained in the registration dossier, the applicant, no later than 30 working days from the date of the change in the relevant data, shall submit (send) to the registering authority:

a) an application for amending the documents contained in the registration dossier (hereinafter referred to as an application for amending), drawn up 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 the relevant changes, including documents confirming the changes specified in subparagraphs "a" - "c" of paragraph 37 of these Rules, as well as in the event of a change in the name of the medical device:

information about the regulatory documentation for a medical device;

the manufacturer's (manufacturer's) technical documentation for the medical device, brought in line with the new name of the medical device;

manufacturer's (manufacturer's) operational documentation for a medical device (including instructions for use or operating instructions for a medical device), brought in line with the new name of the medical device;

photographic images of a general view of the medical device together with the accessories necessary for the intended use of the medical device (at least 18 centimeters long and 24 centimeters wide);

d) documents of the manufacturer and (or) organizations carrying out technical tests, toxicological studies, clinical trials (results of relevant tests), confirming that the introduction of the declared changes does not entail changes in the properties and characteristics that affect the quality, effectiveness and safety of the medical device, or improves the properties and characteristics, while the functional purpose and (or) the principle of operation of the medical device remains unchanged;

e) original registration certificate (duplicate);

f) list of documents.

Information about changes:

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

39. Amendments to the documents specified in subparagraphs "c" and "d" of paragraph 10 of these Rules (except for the cases specified in subparagraph "d" of paragraph 37 of these Rules) is carried out based on the results of an examination of the quality, effectiveness and safety of a medical device, carried out in a manner similar to the procedure for conducting an examination of the quality, effectiveness and safety of a medical device for the purpose of its state registration in accordance with paragraph 21 of these Rules, if the registering authority, based on the results of checking the completeness and reliability of the information contained in the submitted documents, established that the introduction of the declared changes entails a change in the properties and characteristics that affect the quality, efficiency and safety of a medical device, or improves its properties and characteristics, while the functional purpose and (or) the principle of operation of the medical device remains unchanged.

Information about changes:

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

40. If the documents provided for in clause 38 of these Rules are drawn up in a foreign language, they are submitted with a duly certified translation into Russian.

Information about changes:

Clause 41 amended from June 13, 2018 - Decree of the Government of Russia of May 31, 2018 N 633

41. The application for amendments and the documents provided for in paragraph 38 of these Rules are accepted by the registering authority according to the inventory, a copy of which, with a note on the date of receipt of the specified application and documents on the day of acceptance, is handed to the applicant or sent to him by registered mail with an acknowledgment of receipt or in the form an electronic document signed with an electronic signature, or in electronic form via telecommunication channels.

Information about changes:

Clause 42 amended from June 13, 2018 - Decree of the Government of Russia of May 31, 2018 N 633

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

Information about changes:

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

43. Within 5 working days from the date of receipt of the application for amendments and documents provided for in paragraph 38 of these Rules, the registering authority checks the completeness and reliability of the information contained therein, including by comparing such information with information submitted in the interdepartmental information interaction.

Information about changes:

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

44. If documents are not attached to the application for amendments in accordance with subparagraphs "b" - "f" of paragraph 38 of these Rules and (or) inaccurate information is indicated in the application for amendments, or the documents provided for in paragraph 38 of these Rules are presented not in full, the registering authority provides the applicant with a notification about the need to eliminate within 30 days the identified violations and (or) the submission of documents that are absent, or sends such a notification in the form of an electronic document signed with an electronic signature, or in electronic form via telecommunication channels communication, or by registered mail with acknowledgment of receipt.

Information about changes:

Clause 45 amended from June 13, 2018 - Decree of the Government of Russia of May 31, 2018 N 633

45. Within 3 working days from the date of submission of a duly executed application for amending and in full the documents provided for in paragraph 38 of these Rules, the registering authority decides on the consideration of these applications and documents or (in case of their inconsistency with the provisions of paragraph 38 of these Rules ) on their return with a reasoned justification of the reasons for the return.

Information about changes:

Clause 46 amended from June 13, 2018 - Decree of the Government of Russia of May 31, 2018 N 633

46. ​​If within 30 days the identified violations are not eliminated and (or) documents that are missing are not submitted, the registering authority decides to return the application for amendments and documents provided for in paragraph 38 of these Rules, with a reasoned justification for the reasons for the return.

Information about changes:

Clause 47 amended from June 13, 2018 - Decree of the Government of Russia of May 31, 2018 N 633

47. Amendments to the documents contained in the registration dossier that do not require an examination of the quality, efficacy and safety of a medical device are 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 amendments and documents provided for in paragraph 38 of these Rules.

Amendments to the documents contained in the registration dossier requiring an examination of the quality, efficacy and safety of a medical device are 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 amendments and documents provided for in paragraph 38 of these Rules ...

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

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

b) issuing an assignment to an expert institution to conduct an examination of the quality, efficiency and safety of a medical device and assessing the conclusion of an expert institution to determine its compliance with the task to conduct an examination of the quality, effectiveness and safety of a medical device (in the case established by paragraph 39 of these Rules). If it is established that the conclusion of the expert institution does not correspond to the specified task, such a conclusion is returned to the expert institution for revision, the period of which is no more than 2 working days from the date of receipt of the returned opinion by the expert institution;

c) notification in writing of the applicant of the decision taken by registered mail with a receipt acknowledgment or in the form of an electronic document signed with an electronic signature, or in electronic form via telecommunication channels with the attachment of a reissued registration certificate (if changes are made to it) and earlier of the issued registration certificate with a mark on its invalidity (with the date indicated).

Information about changes:

The rules were supplemented with clause 49.1 from June 13, 2018 - Decree of the Government of Russia of May 31, 2018 N 633

49.1. The grounds for the expert institution to issue a conclusion on the impossibility of making changes to the documents provided for in subparagraphs "c" and "d" of paragraph 10 of these Rules are:

a) inaccuracy of the information provided, justifying the introduction of changes, including those identified by the registering authority based on the results state control for the circulation of medical devices;

b) the absence in the documents submitted by the applicant of information confirming that the changes made to the documents contained in the registration dossier do not entail a change in the properties and characteristics that affect the quality, efficacy and safety of the medical device, or improve the properties and characteristics while maintaining the functional purpose and (or) how the medical device works.

Information about changes:

The rules were supplemented with clause 49.2 from June 13, 2018 - Decree of the Government of Russia of May 31, 2018 N 633

49.2. The registering body, within 2 working days from the date of receipt of the conclusion of the expert institution, makes a decision on the possibility (impossibility) of making changes to the documents contained in the registration dossier, and notifies the applicant of the decision taken by registered mail with a receipt acknowledgment or in the form of an electronic document signed by electronic signature, or in electronic form via telecommunication channels.

The basis for making a decision to refuse to amend the documents contained in the registration dossier is the receipt by the registering authority from the expert institution of an opinion on the impossibility of making changes to the documents contained in the registration dossier of a medical device.

Clause 52 clause 38 of these Rules, as well as an application for a duplicate;

b) a copy of the assignment for the examination of the quality, effectiveness and safety of a medical device, drawn up by the registering authority;

c) a copy of the permit issued by the registering authority to conduct clinical trials of a medical device;

d) conclusions drawn up by an expert institution during the examination of the quality, effectiveness and safety of a medical device;

e) copies of orders issued by the registering authority;

f) a copy of the registration certificate or notifications drawn up by the registering authority;

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

Information about changes:

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

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

Information about changes:

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

57. The registering body decides to cancel the state registration of a medical device in the following cases:

a) the applicant's submission of an application for the cancellation of the state registration of a medical device;

b) a court ruling on the violation of the rights of the copyright holder to the results of intellectual activity and the means of individualization equated to them in the circulation of medical devices;

c) submission by the authorized Government of the Russian Federation federal body executive power based on the results of the state control over the circulation of medical devices, information confirming the facts and circumstances that pose a threat to the life and health of citizens and medical workers during the use and operation of medical devices;

Information about changes:

Clause 57 is supplemented with subparagraph "d" from June 13, 2018 - Resolution of the Government of Russia of May 31, 2018 N 633

d) revealing by the registering authority, based on the results of state control over the circulation of medical devices, the inaccuracy of information in the documents contained in the registration dossier, submitted by the applicant and influencing the results of the examination of the quality, effectiveness and safety of the medical device;

Information about changes:

Clause 57 is supplemented with sub-clause "e" from June 13, 2018 - Resolution of the Government of Russia of May 31, 2018 N 633

e) receipt by the registering authority of the conclusions of an expert institution that the instrument, apparatus, device, equipment, material and other products contained in the state register cannot be used for medical purposes and are not medical products according to their functional purpose and (or) principle of operation. Such a conclusion is submitted (sent) by the expert institution to the registering authority within 10 working days from the date of receipt by the expert institution of the corresponding task of the registering body with the documents of the registration dossier attached.

59. Decisions and actions (inaction) of the registering authority that entailed a violation of the rights of a legal entity, an individual entrepreneur, as well as the conclusions of an expert institution based on the results of examinations carried out by it in accordance with these Rules of expertise may be appealed by the applicant in the manner prescribed by the legislation of the Russian Federation.

Registration certificate of Roszdravnadzor(earlier, the Ministry of Health of Russia issued a registration certificate) is a document that confirms the fact of registration of any name of medical purpose on the territory of the Russian Federation, as well as its further entry into the database in which registered medical products are recorded.

Registration certificate of Roszdravnadzor
from 300,000 rubles

The cost of the company's services is determined individually.

As enshrined in the Administrative Regulations of the Federal Service, which is engaged in supervision in the field of social development and health care, concerning the implementation and execution of the state function of registering existing medical products, all received medical products that are planned to be used in the medical industry on the territory of the Russian Federation are registered.

This document was approved by the Order of the Ministry of Social Development and Health of Russia dated October 30, 2006, number 735. This also includes apparatus, instruments and other equipment.

The registration certificate of Roszdravnadzor confirms the fact that this product is permitted for import (or production), use and sale on the territory of the Russian Federation. In other words, for example, a breathalyzer or breathalyzer cannot be used for medical purposes if they do not have such a registration document. In the event of the sale of such a device, the party that sold this product (the seller) is obliged to transfer to the other party (the buyer) a copy of the registration certificate (certificate). The copy is certified.

Speaking specifically about breathalyzers, the registration certificate of Roszdravnadzor indicates that this product (breathalyser) has passed medical tests for effectiveness, quality and safety. In the course of the tests carried out, he actually measured and found an indicator of the alcohol content in the air, which was exhaled by the surveyed persons who did not drink alcohol, and also did not detect alcohol in the surveyed people who did not drink alcoholic beverages. Also, the breathalyzer, as a result of its use, correlated perfectly with those results that were obtained using registered medical equipment and approved methods.

Each individual marketing authorization is assigned its own number. Naturally, in order to determine the validity period of a certain marketing authorization, it is necessary to take into account the time when it was issued.

The process of obtaining a registration certificate from Roszdravnadzor is rather laborious and time-consuming. Therefore, the specialists of our company "RegisterPro" can help in facilitating the receipt of this important document.

Our certifications

Registration certificates for medical equipment- a document that confirms that certain medical devices are registered in the territory of the Russian Federation. Honey. equipment that is used in medical practice must undergo state registration. This document confirms that the equipment complies with all standards established by law. Information on the procedure for passing medical registration is updated every day, changes are constantly being made. Before being used in medicine on the territory of the Russian Federation, absolutely all medical equipment must undergo a mandatory state registration procedure.

Processing time - from 6 months

Licensing authority - Roszdravnadzor

State fee - from 8,000 rubles

Price - from 280,000 rubles

Without this document, medical equipment cannot be used on the territory of the Russian Federation. The document was specially created to prevent harm to the health of Russian citizens and the spread of defective and low-quality medical equipment. Registration medical equipment does not harm human health.

Medical equipment can be used independently, or in combination with other devices, including software for such purposes:

• disease prevention
• therapy
• monitoring the performance of the body and other purposes.

First, they check the entire package of documents submitted by the applicant and the results of examinations of samples of medical equipment. Only after a positive result is obtained, a RU is issued. Registration certificates are not issued for counterfeit equipment of poor quality.

Stages of interaction

Today it is quite difficult to get a reg. certificate. It should be noted that such the procedure consists of various stages that require the provision of a large amount of documents, effort, time and money. The license is obtained only in accordance with the procedure established by law.

First, you need to collect and form a package of primary documentation. Then the necessary papers are submitted to Roszdravnadzor. An examination of registration documents and a clinical trial are in progress. At the end, they issue a RU. Document validity period from five years to an unlimited period, depending on the type of medical equipment.

Standard steps in the document execution process:

• filing an application and a package of documents for registration
• examination of the application and the provided package of documents
• medical equipment examinations
• drawing up acts of completed research
• expert examination of appraisal works
• Making a decision on granting a permit or refusing to issue it (the process lasts about 3-4 months)
• registration of medical equipment
• issuance of a certificate
• entering medical equipment into the State Register of Medical Devices

The process of obtaining RU, the period of registration certificate and payment of fees

The process itself takes six to eleven months. It all depends on the equipment configuration.

Payment state duty for state registration is 8,000 rubles. To make changes to the registration certificate, you need to pay 1200 rubles. For the issuance of a duplicate, 1,200 rubles are paid.

Payment of the state duty for quality and safety checks is:

Class 1 - 45,000 rubles

Class 2a - 65,000 rubles

Class 2b - 85,000 rubles

Class 3 - 115,000 rubles

Difficulties in obtaining a registration certificate

It should be noted that registration of the Registration Certificate is a long and difficult process. It covers many different organizations and resources. All the results of the examinations carried out by the commission for the new honey should be available. technique. In some cases, there are delays at the national and regional levels at the stage of setting costs and deciding on preferential provision. The delay occurs because medical technology developers want to demonstrate good quality and safety to regulators without providing all of the data for tooling analysis. We have to conduct additional research after obtaining a license.

When it is necessary to solve a very difficult certification issue, difficulties may arise when analyzing the documentation, while the time for making a decision on the registration of medical equipment increases.

Register of registration certificates of Roszdravnadzor

Reg. the certificate makes it possible to successfully apply honey. equipment in the Russian Federation. Specialized services will issue such a document that will guarantee the safe operation of the registered medical equipment. The document makes it possible to legally carry out their activities, partially or not to pay taxes at all. It is very important for manufacturers, their partners and consumers that the equipment complies with the regulations.

Registration provides for the following tests:

• toxicological
• technical
• biomedical
• for electromagnetic compatibility
• Clinical

Depending on the degree of possible risk, honey. the technique is divided into four classes: 1, 2a, 2b and 3. The first class includes honey. products of short-term use. Class 2a - medical equipment for temporary use. Class 2b - long-term medical equipment. Medical technology, the constituent parts of which include a substance that has an effect on the body in addition to the effect of medical equipment, belongs to class 3.

Medical equipment is classified according to the degree of possible risk:

Risk class "1" - equipment that has a minimum degree of risk (for example, microscopes, scales).

Risk class "2a" - equipment of medium risk (for example, laboratory equipment).

Risk class "2b" - equipment with an increased level of risk (for example, defibrillators).

Risk class "3" - equipment with the highest risk level (for example, endoprostheses and similar equipment).

Places of application for the document

Registration of medical equipment is handled by the Federal Service for Surveillance in Healthcare, where the license is obtained. The document is issued for the purpose of legalizing medical equipment within the territory. The Roszdravnadzor certificate can be issued for both Russian organizations(firms) and legally registered foreign firms. Reg. certificate for honey. the equipment is obtained, either independently, or with the help of firms that perform their services in a highly professional manner. Each constituent entity of the Russian Federation has territorial body Roszdravnadzor.

Licensing 24 company will help you quickly get required document... Our managers will qualitatively explain and conduct a personal consultation in case of questions . The price of the service is determined individually for each type of honey. equipment taking into account the technical characteristics and scope.

Our mediation in obtaining reg. identity includes the following steps:

• Assistance in the prompt preparation of the submission of documents;
• Solving problematic issues;
• Tracking receipt of RU;
• Discussion with the authorities of important nuances;
• Prompt interaction in terms of finalizing the dock package;

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If you want to get a registration certificate, then first submit an application. The following documents are attached to it:

• a copy of the document proving the competence of the relevant representative of the manufacturer;
• technical and operational documents;
• photography honey. equipment;
• ISO certificate, which confirms the compliance of the equipment with all applicable requirements;
• protocols on the tests carried out honey. Equipment-devices;
• the rest of the papers for a complete assessment of the equipment.

It is necessary to provide an unexpired extract based on the results of the examination from the decision of the Commission on New Medical Equipment. The term of validity of such an extract is no more than two years. Together with the extract, they provide instructions for the operation of the equipment.

Only a professional with extensive experience can determine the required document. For example, complex honey. products, consisting of equipment of foreign manufacturers, sometimes require registration of reg. certificates for honey. equipment for each manufacturer.

The originals of the received forms must be in Russian only (Russian language). A complete package of documents for the state. registration of medical equipment is always certified by a seal and signature. Duplicates or copied documents must be legible, i.e. clear. Copies are bound in a special binder folder.
Ready-made registration notices are issued to the authorized representative with a power of attorney.

Accompanying services:

1. Get Sanitary and Epidemiological Conclusion, it is also on the mandatory list of documents for applying for a medical license. Obtaining a SEZ is required to confirm the compliance of the conditions for performing certain activities regulated by the rules and regulations. The nuances of its design are presented in the corresponding section.
2. ... The high cost of modern diagnostic and therapeutic equipment hinders the expansion of the network medical institutions... An alternative and more affordable way is to rent medical equipment for long or short periods.
3. Is a special right that makes it possible to provide pre-medical, outpatient, pre-medical, inpatient, polyclinic, ambulance, sanatorium, high-tech or resort care. In addition to the fact that it is required by various institutions providing medical care, it may be needed by various beauty salons that provide services in the field of massage, permanent tattooing.

By resorting to our help, you will save your time and for a low price you will receive registration certificate, which confirms the compliance of your medical equipment with all necessary safety standards. We guarantee that you will receive a registration certificate for medical equipment with our company quickly. You will make the right decision if you contact us for help. Additional information can be obtained by phone or e-mail.