Requirements for the production of medical devices. Creating medical devices - problems of regulatory regulation

The article is given a characteristic of a number of questions in the field of medical circulation: insufficient legislative regulation, the lack of systemic work on training, insufficient support of the patient's rights and, as a result, serious problems at the medical organization level.

In this article, we will consider such a most important segment of quality and safety. medical activitieslike the sphere of the appeal of medical devices. On the one hand, the specified area is an independent and very complex component of the provision system. medical care. At the same time, when considering related issues, it will never be forgotten that everything that affects the quality, safety and effectiveness of the use of medical devices, the same affects the quality and safety of medical activities.

Despite the sufficiently large number of regulatory acts regulating the sphere of the appeal of medical devices in Russian Federation, you can confidently state that this area In health care, many positions are the most "muddy." In this regard, in order to somehow increase its transparency, we will consider several obvious problems related to this sphere, and, of course, offer a number of their possible solutions.

Initially, we recall quite the volumetric definitions of two very important concepts, without which it is simply impossible to move, namely: "What is in domestic health care" medical products "and" treatment of medical devices "?".

The definitions of the above concepts are given in Article 38 Federal Law Of the Russian Federation of November 21, 2011 N 323-FZ "On the basis of the health of citizens' health in the Russian Federation" (hereinafter - the foundations):

"1. Medical products are any tools, devices, apparatus, equipment, materials and other products used in medical purposes Separately or in combination with each other, as well as with other accessories necessary to apply the specified intended products, including special software, and intended by the manufacturer for prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body, conducting 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.

3. The appeal of medical devices includes technical tests, toxicological research, clinical trials, the examination of the quality, efficiency and safety of medical devices, their state registration, production, production, import into the territory of the Russian Federation, export from the territory of the Russian Federation, confirmation of conformity, state Control, storage, transportation, implementation, installation, commissioning, application, operation, including maintenance provided for by the regulatory, technical and / or operational documentation of the manufacturer, as well as repair, disposal or destruction. "

From the above definitions you can make one very important conclusion.

Medical products and their appeal are the most complicated multicomponent sphere in both the number of subjects that it covers and the diversity and content of the processes that are continuously implemented in this area.

The validity of this conclusion also confirms the multi-term and diversity of publications, which directly or indirectly addresses issues, anyway associated with the appeal of medical devices. These are the questions of optimal equipment and procurement of medical devices; and questions of rational, safe and efficient use; and issues of quality assurance and patient rights when providing medical care; and questions regulatory regulation In the field of medical appeal.

It is obvious that this is more than enough to make the disposal of medical devices to occupy its place in the domestic health care system in terms of maximum full attention. A certain movement in this direction is scheduled, but while this movement is still very and very modest. Now, then we turn to the problems.

First problem

Legislative regulation of the sphere of treatment of medical devices, which includes a huge number of manufacturers and suppliers, almost all medical organizations And individual entrepreneurs in health care, as well as millions of our fellow citizens as medical users, today absolutely insufficient.

In fact, such a single special regulator is although volumetric, but only one article in the basics, namely, article 38 "Medical Products". Two other articles of the mentioned law, which also refers to medical products, and this is Article 95 "State Control of Medicine Control" and Article 96 "Monitoring Medical Development Monitoring", although they relate to the most important areas for supervision and monitoring in the field of medical circulation Products, but at the same time, it is hardly effective in the absence of clearly prescribed in the legislation of the powers, the functions of medical organizations in the treatment of medical devices. In the current situation, these provisions of the legislation at the level of medical organizations themselves more create or provoke and confuse, and corruption risks in difficult issues related to medical products.

Second problem

In the Russian Federation today there is no systematic work on the preparation of medical personnel to the implementation of activities in the field of treatment of medical devices.

And this is not at all about the fact that we do not teach, for example, the x-ray on which button to click to turn on the X-ray, and how to read X-rays. In-volatile training of specialists is definitely conducted. True, in the same way as it was 30, and 40, and 50 years ago, with amendment for a new technique and electronic technologies Testing students. And, nevertheless, once again we emphasize that systematic work on training for the implementation of activities in the tremendous and most complex area of \u200b\u200bcirculation of medical devices, unfortunately, is not formed.

To make it more clear what we mean under system work is worth looking at the state personnel work in the field of circulation medicines. The Department of Pharmacology, and the Department of Pharmacy, and the Department of Clinical Pharmacology, and the Department of Profile Training of Specialists, including the Department of Public Health and Health, participate in the preparation of specialists. We are not talking about pharmaceutical faculties. The preparation of the same specialists in the field of treatment of medical devices looks like, to put it mildly, is unsuitably modest. But justify this by the fact that this sphere is less important, complex and / or less voluminous than the sphere of drug treatment is a great misconception.

The problem is the third, logically flowing out of the two previous

Heads of medical organizations today are not formed a clear and understandable algorithm for their actions in the field of medical products in a medical organization. Today, only certain components of this work are more or less understandable for executives. Most often three such components:

Acquisition of medical devices;

Preparation and placement of personnel for the use of medical devices;

Maintenance of medical products.

If you relate these fragments of work in the field of medical products with the concepts presented above the definitions of the concepts of "medical products" and "treatment of medical devices", as well as with the fact that it is subject to supervision and monitoring in this area, then the obvious explicit deficiency of such activities becomes obvious.

The problem is the fourth, also logically arising from the previous

With confidence it can be stated that the sphere of the appeal of medical devices in terms of compliance with the rights of citizens, that is, patients are characterized by the most frequent non-compliance with these rights in the public health system in the Russian Federation. This is not a conspiracy on the system, and we are not at all trying to talk about it in our circle on the pages of professional publication, to submit physicians using medical products, such aggressors in relation to patients, and the heads of medical organizations by their accomplices.

Obviously, if there is no adequate regulatory regulation of the sphere of medical devices, there is no systematic work on training for work in this area, there is no clear and clear algorithm for the head of the medical organization, which is miraculous to the patient's right in the field of medical circulation Products?!

And what should be understood under compliance with the patient's rights in the field of medical device's appeal?

It would seem that the answer is extremely simple and understandable: "Compliance with the patient's rights in the field of treatment of medical devices is nothing more than the observance of the patient's rights in the field of the health of citizens prescribed in the basics!". And, nevertheless, we undertake to say that this answer cannot be fully considered today. First of all, because the sphere of circulation of medical devices, of course, has its own specifics, and this is the most specificity of the basics is practically not taken into account.

Yes, and the degree of ignorance by the patient of their rights in relation to medical devices much more than, for example, to drugs, as well as the degree of ignorance medical Personnel His duties in relation to the observance of the patient's rights when using medical products. In other words, the staff should clearly submit what he is to inform the patient in connection with the use of medical devices, and at the same time information on the side effects of medical devices in this case should be far from the only one. The question arises: "And what still needs to speak to the patient about the prescribed medical product, and what documents he is obliged to give in a medical organization if this is a medical device, for example, not only used when providing medical care, but also in the future For a while will be and applied in the patient. "

An orthopedic dentistry is an striking example of legal implications of patient rights in the sphere of treatment of medical products. As is known, hundreds of thousands of thousands, if not millions, our fellow citizens turn to orthopedic dentists about the denthethesis. And here there is a lot of interesting things.

First, today in the Russian Federation, it turns out, there is no single definition that such dentures are. We do not speak about their species, characteristics, design features. It is all, but a single definition, that is, the definitions of non-copyright, but enshrined in law or in regulatory legal act Commissioner on this body, no.

Secondly, there is no definition, respectively, accordingly, no one in the country knows whether the dentures are a medical product or not. It is likely that, most likely, are, but it is only a version or opinion that can be a lot and at the same time.

Third, it is assumed that the dentures are a medical device (and in the interests of the patient, it is better to suggest that), then after the denthesising, the orthopedist dentist is obliged to give the patient to the deployed instruction with the maximum full information about the denture and its further use.

And here again, questions arise: "What does the expanded instruction mean? What does full information mean?". And this means that this information, including its volume and content, must comply with the requirements of the legislation. And the requirements of such a lot. And these requirements are indicated in relation to dentures not only and not even so much in the basics as in the Law of the Russian Federation of 07.02.1992 N 2300-1 "On Protection of Consumer Rights".

How does the situation look like with informing the patient about the denture and their further use after unnotesing today?

The options are as follows.

1. The patient after the denthesting from documents in the hands is given only a cash receipt and nothing else. Everything else may be communicated to the patient verbally.

2. The patient after detonation from documents in the hands is issued a cash receipt and a guarantee document. Everything else may be communicated to the patient verbally.

3. The patient after the progressiveness from documents in the hands is issued a cash receipt, a guarantee document, short description On the use of dentures. The same thing is reported to the patient verbally.

4. A cash receipt is issued to the patient after unnothesting from documents from documents, as well as documents that fully appropriate the requirements of the foundations and law of the Russian Federation of 07.02.1992 N 2300-1 "On the Protection of Consumer Rights".

The last option is definitely ideal, but in practice almost not found in our health care. And this happens again not because in the medical community everything is configured or for the minimum ensuring the rights of the patient, or to non-compliance with them at all. This happens, most likely, because, as evidenced above the above example with detonation, the legislative regulation of the sphere of circulation of medical devices today is not only minimal, but also blurred according to various laws excluding medical specificity. This is especially true of such an important segment of circulation of medical devices, as their appeal directly in a medical organization, that is, where medical products (and more than their most complex them) are most often used.

What to do?

Proposal first

The fact that a separate law is required, regulating the appeal of medical devices, has long been no doubt. Moreover, it is obvious that the absence of such a law, in fact, "substitutes" and the doctor, and the patient in such a complex area as the appeal of medical devices. It is surprising, and already alarming what is completely incomprehensible why such a law in any form (even if it was to improve) has not yet appeared. After all, only over the past 10-15 years, there is no one version of the relevant bills, but not one of them has become a law. An ideal law is impossible to accept, but the presence of the law is better than anything. In general, we offer to the Profile Committee State Duma Force this question that has long been overripe.

Proposition second

I would also like to draw the attention of the legislator to the fact that either in a separate law on medical products, or, may be, before its adoption, it is necessary to reflect the issues of regulating the sphere of medical products directly at the level of medical organization. In this case, the federal law of April 12, 2010 N 61-FZ "On the treatment of drugs" can be a negative example of April 12, 2010, where the regulation of drug treatment at the medical organization level is almost minimized, and most of the heads of medical organizations in addition to what they knew Previously, it was before the adoption of this law, nothing clarifying in the part of its functions and competencies cannot be obtained from it.

The same thing now concerns the sphere of treatment of medical devices. For example, in the basics, in part 3 of Article 95, "state control over the appeal of medical devices", it is said that state control over the appeal of medical devices, among other things, includes monitoring their safety, efficiency and application. In this regard, to comply with the requirements of supervisory authorities, any head of the medical organization needs to be clearly understood that it is obliged to do to ensure the safety, efficiency and proper use of medical devices. Today is out current edition The foundations, as well as from the existing subband acts of such clarity, does not follow. And this means that all we have at least there or may be quite reasonable doubts that these requirements Performed in medical organizations according to a single algorithm, since no legal entitled to the appearance of such a single algorithm is not. And instead there are numerous different opinions of heads of medical organizations and representatives of supervisory authorities on how to ensure safety, efficiency and proper use of medical devices in a medical organization.

Proposition in third

Basics or Separate Medical Products Act must contain detailed provisions on ensuring the rights of citizens in the field of treatment of medical devices, taking into account its specifics:

Provisions on which particular rights of citizens are available in this area;

Regulations on how and what information, including documents, is obliged to provide a citizen medical organization about a medical product used to provide medical care.

Nadezhda for the fact that in this regard is quite enough law of the Russian Federation of 07.02.1992 N 2300-1 "On the protection of consumer rights", is erroneous.

Firstly, with all due respect to this law, its provisions are not adapted to health care issues in the context of medical products, and therefore their interpretation can be quite wide, and not only two or troyakim, which makes any law.

Secondly, this law simply does not apply to medical organizations that do not participate in the OMS system that are not particular and not involved in the relevant paid services. And this includes a large number of phthisitric, psychiatric and other medical organizations that take active activities in the field of medical products.

Fourth offer

It is necessary to start systematic work on training personnel for the sphere of medical products. The first step in solving this problem could be the commissioning of the sectoral ministry to include at the level of the additional vocational education In the training programs, advanced training of health organizers, issues related to the sphere of medical products, primarily at the level of the medical organization themselves. What these may be questions, it becomes clear if you look at the list suggested below internal documentsIt should be developed and approved in each medical organization for regulating the internal order of work, that is, the algorithm itself, in the field of treatment of medical devices.

Proposition fifth

This proposal concerns directly managers of medical organizations. For the formation of a clear, consistent and understandable algorithm for the action of the management of a medical organization in the field of medical circulation, we consider it necessary to propose the following list of internal documents (local regulations), which should be developed and approved directly in a medical organization.

1. The provision on the organization of work in the field of medical device's appeal in a medical organization.

2. Regulations on the responsible person for organizing work in the field of medical product treatment in a medical organization.

3. Rules for the appeal of medical devices in a medical organization.

4. The procedure for organizing work on the implementation of metrological requirements, norms and rules in a medical organization.

5. The procedure for ensuring the safe conversion of medical devices in a medical organization.

6. Regulations on ensuring the rights of citizens in the sphere of medical product treatment in a medical organization.

7. Order internal control Quality, safety and efficiency in the field of medical appeal in a medical organization.

8. Supplements B. job description Head of the Structural Unit of the Medical Organization on the Organization of Work in the Sphere of Medical Products.

9. Supplements to the work instruction of a doctor on work in the field of medical appeal.

The proposed list only calls the possible directions of work of the management of a medical organization in the field of medical circulation. In the next part of this publication, we will try to reveal them.

We are convinced that only if the work in the field of treatment of medical devices in a medical organization will be in the most detailed and clearly regulated by local regulatory actsAlternatively, it will be possible to achieve real security, safety and effectiveness in the field of medical product treatment and only then will be actually effective internal, departmental and state control in this field.

EAT. Astapenko, k.t., head of the Office of the Organization of State Control and Registration of Medical Development of Roszdravnadzor

The article is devoted to the activities of Roszdravnadzor in the field of treatment of medical devices. Describes the main changes in regulatory legal regulation. The requirements for medical devices under their appeal on the territory of the Russian Federation are given.

As one of the main powers Federal Service For supervision in the field of healthcare (service, Roszdravnadzor) from the date of its formation so far is the implementation of state control in the field of medical circulation. For a 10-year history of the service, its powers were significantly expanded in this area - from the supervision of compliance with state standards, technical conditions for medical products, controlling production, turnover and procedure for the use of medical products, registration of medical products prior to the implementation of state control in the field of treatment of medical devices through conducting inspections of compliance with the subjects of the treatment of medical devices in the field of treatment of medical devices, issuing medical devices to the territory of medical devices in order to their state registration, State registration of medical devices and maintaining a state register of medical devices and organizations (individual entrepreneurs), carrying out the production and manufacture of medical devices.

Currently, Roszdravnadzor carries out state control at all stages of the treatment of medical products: control over technical testing, toxicological studies, clinical trials, efficiency, safety, production, manufacturing, implementation, storage, transportation, import into the territory of the Russian Federation, export from the territory of the Russian Federation, By their installation, commissioning, application, operation, including maintenance, repair, use, disposal or destruction.

To implement the above objectives in the structure of Roszdravnadzor, the management of the organization of state control and registration of medical devices (management) has been created, which today includes 4 structural divisions:

Department of registration of medical devices;
- Department of Changes in registration documents;
- department of the organization and conduct of state control over the appeal of medical devices;
- Department of registries and analytical work.

Thus, management activities can be divided into two directions: registration of medical devices and control over the appeal of medical devices.

Important service is the possibility of implementing powers within the framework of current legislation. In this regard, throughout the time of the formation and existence of the service, the process of improving regulatory legal regulation in the field of treatment of medical devices, which continues to present. As one of the examples of improving legislation, it is possible to transition from the concepts of "medical products" and "medical equipment" to the concept of "medical product", introduced by Art. 38 of the Federal Law of 21.11.2011 No. 323-FZ "On the basis of the health of citizens' health in the Russian Federation" (hereinafter - the law). Under medical products are understood "Any tools, devices, apparatus, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as with other accessories necessary to apply the specified intended products, including special software, and intended by the manufacturer for prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body, conducting 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 influence on the human body. "

According to the law, in the territory of the Russian Federation, the appeal of medical devices registered in the manner prescribed by the Government of the Russian Federation authorized by him federal organ executive power. A document confirming the fact of state registration of a medical product is a medical certificate.

Before submitting applications and documents for state registration of medical devices, it is necessary to conduct technical and toxicological (if necessary) testing of the product, and for medical products of foreign production (from August 14, 2012) - to obtain permission to import them for state registration, the procedure for issuing which is carried out in accordance with the order of the Ministry of Health of the Russian Federation of June 15, 2012 No. 7n "On approval of the procedure for entering into the territory of the Russian Federation of medical devices in order to state registration." The issued permission to import a medical product is really within six months from the date of its issuance.

In the process of improving the regulatory regulation, changes and the procedure of state registration of medical devices were made: today it is carried out in accordance with the rules of state registration of medical devices, approved by the Decree of the Government of the Russian Federation dated December 27, 2012 No. 1416, and is a two-stage procedure based on the results technical tests, toxicological studies and clinical trials. In the event of a decision on state registration of the medical device, Roszdravnadzor draws up and issues a registration certificate for a medical product.

At the moment, more than 37 thousand medical devices were registered on the territory of the Russian Federation. Information about registered in installed manner Medical products are posted on the official website of Roszdravnadzor www.roszdravnadzor.ru in section. "Medical products (medical products)" - "The State Register of Medical Products and Organizations (Individual Entrepreneurs), carrying out the production and manufacture of medical products" (hereinafter referred to as the State Register).

As part of measures for state control over the appeal of medical devices Roszdravnadzor and its territorial bodies Supervisory measures are carried out on compliance with the organizations of compulsory requirements in the production, circulation and use of medical devices, in the process of which, including, the quality, efficiency and safety of medical devices is carried out by sampling. Examination of the quality of the effectiveness and safety of medical devices is carried out by subordinate expert organizations (FGBU "VNIIIMT" Roszdravnadzor and FGBU "TsMIKEE" Roszdravnadzor), on the basis of the results of which in the event of a threat to causing harm and health of citizens Roszdravnadzor may be decided to abolish the state registration of the medical product .

Among the most common disorders during control and supervisory measures, the following can be distinguished:

Non-compliance of the name of the medical device, declared in the registration certificate, the name indicated on the labeling of the medical product;
- lack of information in Russian;
- lack of information about the place of location (address), brand name (name) of the manufacturer (seller), location (address) of the organization (organizations) authorized by the manufacturer (seller) to accept complaints from buyers;
- lack of information about the state registration of the medical product;
- unreliable information in technical conditions on the medical products produced;
- unreliable information in registration certificates for medical products and licenses for production and maintenance (except for the case, if the indicated activity is carried out to ensure own needs legal entity or individual entrepreneur) medical equipment indicating an invalid location (old address).

Therefore, it should be paid to the fact that the medical product must be accompanied by:

1) information on the registration certificate, the address of the production site indicated on the medical product and in the accompanying documentation and the relevant information contained in the State Register; At the same time, the implementation of medical devices on the territory of the Russian Federation with an expired registration certificate;
2) with reliable information in Russian on the packaging of a medical product containing information about the product name, the manufacturer (its name and place of production), the date of production, the expiration date (service life), the registration certificate number;
3) instructions for a medical product containing information on indications and contraindications to use, methods of its use.

According to the results of control and supervisory measures and the expertise of medical devices, Roszdravnadzor on the official website of www.roszdravnadzor.ru in Section. "Medical products (medical products)" - "State control over the appeal of medical devices" - "Search for decisions of Roszdravnadzor about medical devices (information letters)" are posted with relevant information letters about unregistered medical products, as well as medical devices that do not correspond to the established established Requirements.

According to the analysis of statistical data on the identification of unregistered medical devices (Fig. 1) in the territory of the Russian Federation, over the period from 2006 to 2013, their significant increase is observed (more than 8 times), which is associated with the annual increase in the supervisory measures of Roszdravnadzor, as well as improving regulatory regulation, in particular entry into force Administrative regulations Federal Health Supervision Service state function According to the control of the appeal of medical devices, approved by the Order of the Ministry of Health of Russia dated April 04, 2013 No. 196n. At the same time, it should be noted that in the first half of 2014, 282 names of unregistered medical devices were revealed.

The greatest number of unregistered medical devices is detected among:

Points of corrective and rolling glasses corrective;
- reagents for in vitro-diagnostics;
- products for children under 3 years and nursing mothers with medical purposes;
- orthopedic goods (belts, insoles, knee pads);
- Massager and physiotherapy medical devices;
- diagnostic equipment (planxtographs, heights, bronchoscopes, etc.);
- Medical Function Function (Vata, Bandages, Plockers, Masks, Medical Clothing, Napkins, Disinfectants).

An important innovation in the field of medical appeal was the opportunity from January 1, 2014 to attract administrative responsibility For non-compliance with the rules for the treatment of medical devices, provided for by Art. 6.28. Code of the Russian Federation "On administrative offenses" In accordance with this article, the following size is set. administrative fine:

 The citizens - from 2 to 4 thousand rubles;
 by officials - from 5 to 10 thousand rubles;
 on legal entities - from 30 to 50 thousand rubles.

Currently developed by the Ministry of Health of Russia together with Roszdravnadzor regulatory legal acts In the field of treatment of medical devices aimed at harmonization russian legislation With international, which is primarily due to the introduction of the Russian Federation to the Steering Committee of the International Forum of Medical Product Regulators (IMDRF), which also includes representatives of Canada's regulators, USA, EU, Australia, Brazil, China, Japan.

Taking into account international experience, the federal law "On the appeal of medical products" is being developed, the entry into force of which will allow to resolve a number of controversial issues and overcome the "gaps" of regulatory regulation in the field of treatment of medical devices related mainly to the presence of a significant number of regulatory acts in this Region, which will undoubtedly, will allow generally to improve the conduct of control and supervisory measures and improve the quality, efficacy and safety of medical products contacting the territory of the Russian Federation.

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 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.

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. 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 - day deadlines for violations and (or) submission of documents that are missing or sends such a notification by registered mail with a notice of delivery 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:

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);

b) at stage II, an examination of the completeness and results of technical testing conducted, toxicological studies, clinical trials, as well as tests in order to approve the type of measuring instruments (in relation to medical devices belonging to the measurement tools in the field state regulation 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.

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.

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.

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 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.

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.

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:

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;

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;

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.

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

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.

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

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.

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

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.

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 on the results of state control over 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) 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;

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 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 authority 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 with 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.

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.

I argue:

Chief Physician OGAUZ "Bratsk

Ageeva TR

General provisions

1, these Rules are designed to ensure quality, efficiency and security of medical activities.

2. The appeal of medical devices includes arrival at the warehouse, installation, setting, commissioning, use, operation, including maintenance provided for by the regulatory, technical and (or) manufacturer's operational documentation, as well as repair, disposal or destruction. Medical products combine instruments, tools, equipment used in medical practice.

The rules have been developed in accordance with the Federal Law "On the Protection of Citizens in the Russian Federation", the order of the Ministry of Health and Social Development of Russia No. 1198n dated December 27, 2011 "On approval of the rules in the field of treatment of medical devices" by the Regulation on state control For the appeal of medical devices, approved by the Decree of the Government of the Russian Federation of September 25, 2012 No. 970 and the Regulations on State Quality Control and Safety of Medical Activities, approved by Decree of the Government of the Russian Federation of November 12, 2012 No. 1152.

3. effects of these rules extend to all structural units Institutions providing medical care.

4. Requirements of these Rules are mandatory for all medical workers' brotherly dental polyclinic №3 "

Appeal of medical devices in OGAZ "Brotherly Dental Polyclinic No. 3"

The institution allows the appeal of medical devices registered in the manner prescribed by the Government of the Russian Federation authorized by the federal authority of the executive.

1. A document confirming the fact of state registration of a medical product is a medical certificate (hereinafter referred to as a registration certificate).
2. Transportation and storage of medical devices is carried out in accordance with the requirements established in the technical and (or) operational documentation of the manufacturer at the medical consideration in Russian.

Mounting and adjustment rules of medical devices.

1. Installation and commissioning of medical devices is carried out in accordance with the technical and (or) operational documentation for the medical product, which is provided with a medical product, as well as in accordance with the documents for the supply of medical devices and (or) installation of medical staff.
2. When making installation and commissioning of medical devices, the requirements of the legislation of the Russian Federation in the field of occupational safety and safety should be respected.

At the end of the installation and commissioning work:

1. test technical tests in order to verify the health of the medical product and comparing the results obtained with the requirements established in the technical and (or) manufacturer's operational documentation on the medical consideration;
2. training of medical workers and technical specialists rules of application, operation and maintenance medical product (in the amount provided by technical documentation Manufacturer) with an appropriate entry in the act of acceptance.

According to the results of the relevant work, the protocol of the test results is made, the act of passing the work and the introduction of a medical force into operation, the form of which is approved by an authorized federal executive body.

Rules for the use and operation of medical devices.

1. The use (operation) of medical devices is carried out by a medical worker in accordance with the manufacturer's operational documentation on medical consideration.
2. With the use and operation of medical devices, medical workers are obliged to report all cases of side effects not specified in the instructions.
3. Operation and application of medical devices not provided by maintenance or removed from maintenance is unacceptable because it is a danger to a patient and a medical worker.

Terms of maintenance and repair of medical devices.

1. Maintenance of medical devices in the warranty and post-warranty period is mandatory condition effective application and safe operation their uses for their intended purpose. Maintenance of medical products provided for by the regulatory, technical and / or operational documentation of the manufacturer is carried out under a contract with legal entitiesWith a license for the implementation of technical maintenance activities of medical devices.
2. Measures on maintenance and repair of medical devices should be carried out in accordance with the provisions of the corresponding regulatory, technical and operational documents.
3. It is prohibited to use (operation) of medical devices who have not passed

maintenance in the prescribed form, in case such service is provided for technical and (or) manufacturer's operational documentation, or filmed from technical service.

1. Medical workers carrying out the use (operation) of medical

Products, must be trained by the rules for the application and operation of medical

products.

1. Responsible for the appeal of medical devices is obliged to ensure the passage of medical workers using (operating) medical products, briefing on the rules for its application (operation) or to familiarize such workers with operational documentation for a medical device with a signature of an employee about factories.
2. The heads of departments engaged in the use (operation) of medical devices are required to conduct accounting and reporting documentation for the maintenance of medical staff:

Maintenance logs of medical staff;

Protocols (acts) of monitoring the technical condition of medical studies;

Technical maintenance schedules.

1. Application (operation) of the medical product outside established period The medical device service is allowed if the extension of the service life of the medical product is provided for technical and (or) manufacturer's operational documentation on medical consideration.
2. The extension of operation and application of the medical product is considered if such an extension is not prohibited or not established in the technical and (or) manufacturer's operational documentation for the medical product, and on the basis of the order of the Chief Doctor.

Rules for disposal or destruction of medical devices.

When using medical devices relating to measuring instruments in the field of state regulation of ensuring unity of measurements, the requirements for such products established by the legislation of the Russian Federation on ensuring uniqueness disposal and destruction of medical devices

Medical products are subject to recycling and (or) destroying luster:

1. expirations of the service life of the medical product (rated birth);
2. confirmation of facts and circumstances that create a threat to the life and health of citizens when using or operating registered medical studies;
3. confirmation of information that medical products are falsified and (or) low-quality and (or) unsafe.

Disposal or destruction of medical devices should be carried out in accordance with the regulatory, technical and operational documents of the manufacturer

Falsified, poor-quality and unsafe medical products are subject to withdrawal from circulation and subsequent destruction. The destruction of falsified, low-quality medical devices is made by the supplier of these products.

Ensuring the rights of citizens in the field of medical circulation

1. A citizen in the sphere of medical products in a medical organization has the right to: - to receive full and reliable information about medical products that can be used to provide him with medical care, regardless of their presence or absence in this medical organization; - refuse to use this or that medical product to provide him with medical care;
2. Compensation of harm caused by the health of citizens due to the use and operation of medical devices or the commission illegal action The subjects of the appeal of medical devices are carried out in accordance with the legislation of the Russian Federation.

Responsibility for violation of the rules for the treatment of medical devices

All responsible persons and medical workers carry civil, legal, administrative, criminal and disciplinary responsibility In accordance with the current legislation, for violation of the rules in the exercise of professional activities.

Prepared: Deputy Movcha

Medical part Andreeva M.F.

I argue:

Chief Physician OGAUZ "Bratsk

dental polyclinic number 3 "

Ageeva TR

Provision on the responsible person for organizing work in the field of treatment of medical devices in OGAUZ No. 3 - Dental Polyclinic

1. General Provisions

1.1 Indeed provision applies to the responsible for the organization of work in the field of treatment of medical devices in OGAZ "Brotherly Dental Polyclinic No. 3"

1.2 Responsibility responsible for organizing work in the field of treatment of medical devices are assigned to the deputy chief physician for the medical unit.

1.3 Responsible for the organization of work in the field of treatment of medical devices obeys the chief doctor of OGAZ "Brotherly Dental Polyclinic No. 3"

2. Basic objectives responsible for organizing work in the field of medical appeal

2.1 Organization of work to ensure quality, safety and efficiency in the field of medical products in the institution.

3. Responsibilities and rights responsible for organizing work in the field of medical deviations in OGAZ "Brotherly Dental Polyclinic No. 3"

3.1 Share responsible is to verify the equipment of a medical organization for compliance with the standards established by the procedures for providing medical care.

3.2 Responsible conducts timely inspection registration certificates on existing medical products.

3.3 Organizes the maintenance of medical equipment.

3.4 carries out control of the presence of verification results from medical devices relating to measurement tools.

3.5 monitors the observance of the responsibility of medical workers to identify and inform about side effects and unwanted reactions when using medical products.

3.6 Take measures to eliminate violations in the field of treatment of medical devices.

Prepared: Deputy Head

According to the medical part of Andreeva, M.F.

I argue:

Chief Physician OGAUZ "Bratsk

dental polyclinic number 3 "

Ageeva TR

Order

Internal quality control, safety and efficiency in the field of medical device

This procedure is developed in accordance with the Regulations on state control over the appeal of medical devices, approved by the Decree of the Government of the Russian Federation of September 25, 2012, No. 970 and the Regulations on State Control of Quality and Security, approved by the Decree of the Government of the Russian Federation of 12.11.2012 №1152.

1. Internal quality control, safety and efficiency control in the field of medical circulation:

1.1 Ensuring the availability of medical registration products, a certificate of compliance, the necessary regulatory, technical and operational documentation of the manufacturer necessary for the use and operation of the medical product.

1.2 Ensuring compliance with the requirements of regulatory, technical and operational documentation for the storage, application and disposal of medical devices.

1.3 Ensuring compliance with installation requirements, commissioning, operation of medical devices, including maintenance and repair.

1.4 Ensuring the periodic calibration of measuring instruments.

1.5 Ensuring monitoring the security of medical devices.

12.6 Prevention of disorders in the field of medical treatment of medical purposes.

2 .Vids internal quality control of medical products

Types of internal control	Responsible persons	Periodicity control
Determining the need for medical products	Deputy. GL Medical doctor. Parts Andreeva M.F. Head Departments Zhikhareva OS, Dyachenko M.N.	1 time per month
Studying availability, the degree of need for honey. Technique, Measurement Means	Deputy Gl Doctor of Medical School Andreeva M.F.	2 times per year
Purchase of medical products	Procurement Commission	With each purchase
Storage, Accounting, Issuing Medical Products		Constantly
Tracking on the Roszdravnadzor website information about unregistered medical products	the main nurse Polyclinics	Weekly
Monitoring the absence of unregistered medical products	Deputy Movcha on honey. Parts	Monthly
Organization of work on the collection, analysis and direction of information in case of detection of side effects with medical workers in the use and operation of medical devices	Deputy Head of Medical Part	Within 20 days in case of detection
Providing information to the deputy head physician on honey. Parts of the case of detection of a side reaction of the PR of the use and operation of medical devices	Medical personnel	Wage 3 working days
Ensuring compliance with installation requirements, adjustment of medical equipment	Acceptance Commission	When commissioning
Ensuring compliance with the requirements for the operation of medical devices and medical equipment	Medical workers, departments, departments, deputy.	Constantly
Ensuring timely verification of measuring instruments	Main Medical Sister Polyclinic, Deputy Movcha on honey	On schedule
Maintenance and repair of medical equipment	The organization that carries out and repair honey. Equipment. Strong honey. Sister Polyclinic.	In accordance with the requirements of technical documentation
Compliance with the requirements of the disposal of medical products	Main medical sister Polyclinic.	Under the recycling

"Pharmacy: Accounting and Taxation", 2012, N 12

On the website of the Ministry of Health, the draft order was published "On approval of the Rules in the Sphere of Medical Products" (hereinafter referred to as the project), which establishes new rules concerning production, import, control, transportation, implementation, and the use of medical devices. We have prepared a small review of the future regulatory documentwhich will be interesting for managers of pharmacy institutions.

The draft document in the field of treatment of medical devices is designed in accordance with Art. 95 of the Federal Law of 21.11.2011 N 323-FZ "On the Fundamentals of the Health of Citizens in the Russian Federation" (hereinafter referred to as the basis for the protection of citizens' health in the Russian Federation). With the entry into force of its norms, the order of the Ministry of Health of Russia dated 13.11.1996 N 377 will cease to operate "on approval of the instructions for organizing storage in pharmacy institutions of various groups of medicines and medical products" (hereinafter referred to as the order No. 377).

For reference. To date, the order N 377 operates in part of the storage of medical devices. In connection with the adoption of the order of the Ministry of Health and Social Development of Russia of August 23, 2010 No. 706n, who approved the rules for storing medicines, its norms in terms of storage of medicines have lost force.

The project contains the following sections:

1. Requirements for the production and manufacture of medical devices.
2. Import into the territory of the Russian Federation and export from the territory of the Russian Federation medical devices.
3. Rules for the storage and transportation of medical devices.
4. Implementation of medical devices.
5. Requirements for installation and commissioning of medical devices.
6. Application and operation of medical devices.
7. Maintenance and repair of medical devices.
8. Rules for disposal or destruction of medical devices.

Before moving to the position of the project, we note that two concepts appear in medical activities - "Medical appliances" and "medical products". However, in accordance with Art. 38 The foundations of the health of citizens in the Russian Federation, they are combined into the concept of "medical products". Given the terminology given in this article, the medical products are any tools, devices, apparatus, equipment, materials and other products used for medical purposes separately or in combination between themselves, as well as with other accessories necessary to apply the specified products for appointment, including special software, and designed by the manufacturer for prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body, conduct medical research, restoration, replacement, changes in the anatomical structure or physiological functions of the body, preventing or interrupting pregnancy, whose functional purpose It is not realized by pharmacological, immunological, genetic or metabolic impact on the human body.

Medical products can be confusing interchangeable if they are comparable to functional purposes, high-quality and specifications and are able to replace each other (art. 38 of the foundations of the health of citizens in the Russian Federation). In accordance with the order of the Ministry of Health of Russia of 06.06.2012 N 4N, medical products are classified by types and classes depending on the potential risk of their application.

The nomenclature classification of medical products by type contains a numerical designation (number) of the type of medical product, the name of the type of medical product, as well as nine-digit digital codes (AAA BB GG) used to determine the types of medical devices.

IN Nomenclature classification Medical products by classes depending on the potential risk of application All products are divided into four classes. Classes have designations 1, 2a, 2b and 3.

When classifying medical devices (except medical devices for diagnostics in vitro), each product can only be assigned to one class:

• class 1 - a low risk name;
• class 2a - IMN with an average risk;
• class 2B - IMN with an increased degree of risk;
• class 3 - Non with a high risk.

On the territory of the Russian Federation, the appeal of medical devices registered in the manner prescribed by the Government of the Russian Federation authorized by him by the federal executive body (Article 38 of the foundations of the health of citizens in the Russian Federation).

Consider the requirements of each project section in more detail.

Requirements for the production and manufacture of medical devices

Requirements for the production and manufacture of medical devices will regulate the obligations of the manufacturer who are as follows. In accordance with the provisions of this section, the manufacturer of medical devices will be obliged to develop regulatory, technical and (or) operational documentation for the medical product, in accordance with which its production, manufacturing, storage, transportation, installation, commissioning, application, operation will be carried out, including Maintenance, as well as repair, disposal or destruction. The exceptions will be medical products that will be manufactured by individual patient orders and to which special requirements for the appointment of medical workers will be presented exclusively for personal use of a specific patient.

In the manufacture of medical devices for individual orders, patients must be respected by special requirements for the purpose of medical professionals specified in the prescription blanks issued in accordance with the Procedure established by the Ministry of Health.

In case of identifying side effects not specified in the instructions for the application or manual for the operation of medical products, unwanted reactions when applying, the features of the interaction of medical devices among themselves, facts and circumstances, creating a threat to the life and health of citizens and medical workers in the use and operation of medical Products, the manufacturer of a medical product is obliged to make appropriate changes to the regulatory, technical and (or) operational documentation and notify Roszdravnadzor.

Import into the territory of the Russian Federation and exporting medical products from it

Requirements in part of the importation in the territory of the Russian Federation and the export of medical products indicate compliance with the provisions of the regulatory documentation established in this area.

Unregistered medical products can be imported into the territory of the Russian Federation and exported from it without permission to import medical devices if they are intended for:

• personal use individualswho arrived in the territory of the Russian Federation;
• use by employees of the diplomatic corps or representatives international organizationsaccredited in the Russian Federation;
• treatment of passengers and crew members vehicle, train brigades and drivers of vehicles arriving in the territory of the Russian Federation;
• the treatment of participants in international cultural, sports events and participants of international expeditions, as well as for exhibitions;
• registration of a medical product in accordance with the order of the Ministry of Health of the Russian Federation of June 15, 2012 No. 7N "On approval of the procedure for importation into the territory of the Russian Federation of medical devices for state registration."

In the case of registration of side effects, undesirable reactions, facts and circumstances, creating a threat to causing harm and health of people in assessing the compliance of the medical product (technical testing, toxicological research, clinical trials, as well as tests in order to approve the type of measuring instruments) imported to The territory of the Russian Federation, its manufacturer or an authorized legal entity ensures export from the territory of the Russian Federation or the destruction (disposal) on its territory of this medical product.

Rules for storing and transporting medical devices

In the section "Rules for storing and transporting medical products" the project states that the storage of medical devices is carried out by a medical product manufacturer or an authorized legal entity or an individual entrepreneur registered in the territory of the Russian Federation in the prescribed manner, organization wholesale trade medical devices, pharmacy organizations, individual entrepreneurs, medical organizations and other organizations that carry out the appeal of medical devices.

• medical products;
• plastic products;
• products of medical equipment.

Requirements for storage and transportation of medical devices are set by a manufacturer of medical devices in the regulatory, technical and (or) operational documentation.

Implementation of medical devices

The implementation of medical devices can be carried out:

• manufacturer;
• wholesale and retail organizations;
• individual entrepreneurs and other organizations carrying out the appeal of medical devices.

Persons carrying out the implementation of medical devices, it is prohibited to sell poor-quality, falsified, counterfeit medical products, not relevant mandatory requirements To products, as well as implement medical products that are manufactured by individual orders of patients.

Persons implementing medical devices are required:

• comply with the requirements established by the manufacturer of the medical product;
• exercise pre-sale preparation;
• ensure installation and commissioning of medical devices in accordance with the requirements established by the manufacturer in operational documentation;
• provide the manufacturer's operational documentation necessary for the use, operation and maintenance of the medical product, maintaining it in a good and efficient state;
• provide special training for medical professionals using and operating medical products, as well as specialists carrying out maintenance and repair;
• ensure the patient in the event of a medical product implementation for its personal use by the necessary operational documentation supplied with it.

Installation, commissioning, operation, maintenance

In the section "Requirements for installation and commissioning of medical devices" the project states that the installation and commissioning of medical devices are carried out in accordance with the regulatory, technical and / or operational documents of the manufacturer of the medical product, which are provided with the product, as well as in accordance with the Treaty ( contract) for the supply of medical devices.

The use and operation of medical devices will have to be carried out by the subjects of the appeal of medical devices in accordance with the instructions for application or manual for the operation of the medical product.

With the use and operation of medical devices, subjects of their appeal are obliged to report all cases of identifying side effects not specified in the instructions for the application or manual, unwanted reactions when applying, the features of the interaction of medical devices among themselves, facts and circumstances that create a threat to life and Health in accordance with the procedure approved by an authorized federal executive body.

Maintenance and repairs will be carried out by legal entities or individual entrepreneurs in order to maintain and restore the health and performance of medical products when they are used for their intended purpose.

Note! Medical products, maintenance and repair of which are provided in the regulatory, technical and (or) manufacturer's operational documentation are subject to maintenance and repair.

The obligation to carry out the maintenance and repair of the medical product during the warranty period will lie on the manufacturer of a medical product or an authorized representative of the manufacturer, and in the post-warranty period - on the subjects of the treatment of the medical product carrying out its application and operation.

Rules for disposal or destruction of medical devices

In the section "Rules of Recycling or Destruction of Medical Development" of the Project says that medical products are subject to disposal or destruction in the case of:

• confirmation of facts and circumstances that create a threat to the life and health of citizens and medical workers in the application and operation of registered medical devices;
• expiration date or exploitation;
• confirmation of information that medical products are falsified, poor-quality and unsafe.

Disposal or destruction of medical devices are carried out in accordance with the classification, rules for collecting, use, disposal, accommodation, storage, transportation, accounting and disposal of medical waste established by the authorized federal executive authority.

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In conclusion, we will note that the project will most likely be finalized and supplemented with articles related to storing medical products.

M.R.Zipova

Expert journal

"Pharmacy: Accounting

and taxation "