Medical Devices Market in Russia

Domestic production

Main article: Import substitution of medical devices

As of April 2018, in total, about 400 enterprises are engaged in the production of medical devices in Russia.

The country produces $33 worth of medical devices per capita per year. For comparison, in Kazakhstan this figure is $80, in Spain - $145, in Germany - $290, in the USA - $550.

The most significant regions of Russia for 2019 in the field of production for healthcare in Russia are mainly southern: Altai Territory, Primorsky Territory, Khabarovsk Territory, Amur Region, Irkutsk Region. Also, production centers are Moscow, St. Petersburg, Kazan.

Medical equipment

Main article: Medical equipment (Russian market)

Medical mattresses

Main article: Medical mattresses (Russian market)

Registration of Medical Devices

Main article: Registration of medical devices in Russia

Price regulation

Main article: Price regulation of medical devices in Russia

Export

Main article: Export of medical devices from Russia

Main article: Export of medical devices from Moscow

Chronicle

2024: How state support for the production of medical products for tens of billions of rubles is arranged in Russia

On October 8, 2024, it became known about a set of state support measures aimed at developing the production of drugs and medical devices in Russia. The financing system for projects in the pharmaceutical industry and the production of medical devices includes several key tools implemented with the participation of ВЭБ.РФ.

According to Kommersant, the first deputy chairman of the ВЭБ.РФ, Alexander Braverman, revealed the details of the four main mechanisms for supporting the industry. The first instrument is the cluster investment platform (IC) of the Ministry of Industry and Trade, which provides a preferential rate of 8.7% per annum. Four projects are already being implemented within the instrumentation framework, two of which are in a high stage of readiness with a total investment of ₽65 billion.

State support for the production of medical devices in Russia is tens of billions of rubles

Among the projects that received support through instrumentation, the initiative of Pharm-Sintez Group of Companies to organize the production of a full cycle of drugs against cancer stands out. Also significant is the project of FSUE Endopharm, aimed at producing strategically important low-margin products.

The second tool is the Project Financing Factory, focused on large projects worth from ₽3 billion. Within the framework of this mechanism, the possibility of financing the creation of a federal network of medical centers is being considered. The project was initiated by JSC, "Medskan" 50% of which belongs to a private investor, and the other 50% to the state corporation Rosatom"."

The third tool is aimed at supporting enterprises of the military-industrial complex producing civilian products at a rate of 5% per annum. ВЭБ.РФ, together with the Ministry of Industry and Trade, is working on a project to expand the production of prosthetic and orthopedic products with NPO Metalist, which is part of the Rostec Group of Companies.

The fourth instrument provides for the provision of guarantees for loans from the Industrial Development Fund. If there is a guarantee ВЭБ.РФ the initiators of the projects can receive a loan from the FRP for the purchase of equipment at 3% per annum.

Alexander Braverman emphasized the possibility of combining various support tools. For example, it is possible to combine instrumentation with the guarantee of a commercial bank credit ВЭБ.РФ, which allows you to optimize the financial structure of projects.

Particular attention is paid to projects aimed at ensuring the drug independence of Russia. In particular, projects for the production of pharmaceutical substances of JSC NIOPIK and the production of crystalline microcellulose of Christacel Technologies LLC are being prepared for consideration. The latest project is an example of an integrated approach to supporting the high-tech industry: grant support is provided by the Skolkovo Foundation, credit financing is provided by the ВЭБ.РФ, and guarantee support is provided by the SME Corporation.

Russian Minister of Industry and Trade Anton Alikhanov noted the important role of the ВЭБ.РФ in supporting the Moscow Endocrine Plant, which is implementing a large-scale program for the production of pharmaceutical substances. This program will provide not only the plant itself, but also other pharmaceutical enterprises with active pharmaceutical substances of domestic production.^[1]

2023

The production of consumable medical materials in Russia for the year decreased by 5.5% to 13.08 billion units

In 2023, the production of consumable medical materials in Russia amounted to 13.08 billion units. This is 5.5% less compared to 2022, when the volume of output was estimated at 13.84 billion units. Such data are given in the BusinesStat study, the results of which were published in mid-September 2024.

The review looks at medical masks, gloves and hats, patches, bandages, gauze wipes, cotton wool and dressings, test tubes and biomaterial collection containers, syringes, needles, catheters, cannulas and similar instruments. Among the significant players in the industry are named Vector-Best JSC, Elatomsky Instrument Plant JSC, NPF Sintol LLC, MPK Yelets LLC and Medpol LLC.

In 2019, according to estimates, the production of consumable medical materials in the Russian Federation was at the level of 6.28 billion units. In 2020, a sharp increase was recorded: the volume of production increased by 76.8%, reaching 11.1 billion units. Against the background of the COVID-19 pandemic, the demand for individual protective equipment has risen - masks, gloves, etc. In addition, the growth of production was facilitated by the implementation of the state program "Development of the pharmaceutical and medical industry" for 2013-2020, under which more than 160 projects on medical devices were financed. Realizing the dependence of the market on imports, the Government of the Russian Federation applied a number of protectionist tools that stimulated domestic manufacturers to increase production.

In 2022, the volume of production rose by 6.5%, but in 2023 there was a decline. Some of the lost positions in the Russian market have regained imports due to the establishment of supply chains and a mechanism for parallel imports, an increase in supplies from Asian countries. In addition, the production of personal protective equipment continued to decline as the epidemiological situation improved.^[2]

Growth in the volume of public procurement of medical products and medicines by 7% to 1.15 million transactions

The volume of state purchases of medical devices and medicines in Russia in 2023 increased by 7%, reaching 1.15 million transactions. Such data at the end of spring 2024 leads the service "Kontur. Bargaining." In monetary terms, the total volume of purchases amounted to 2.12 trillion rubles, of which 950 billion rubles. falls on medical equipment and related tools.

According to Kontur. Torgi, the number of transactions for the purchase of medical equipment increased by 14%, reaching 399 thousand procedures. The total amount of these purchases increased by 5%, amounting to 596 billion rubles. According to Rosstat, the volume of the Russian market for medical devices in the first half of 2023 reached 381 billion rubles, of which 320 billion rubles. fell on public procurement. Retail sales of medical and orthopedic products also increased by 6.8%, exceeding 300 billion rubles.

The Ministry of Industry and Trade reports that the share of domestic production of medical equipment in 2023 reached 29%, continuing the growth trend. However, domestic production is still significantly inferior to the volume of medical device imports.

Vladimir Kozhevnikov, chief designer of the Russian Orbital Station (ROS), noted that the design of the station will allow receiving spacecraft from different countries if their docking units meet international ROS standards and parameters. The station will use the latest materials and technology, including additive technology and 3D printers for plastic printing.

Deputy Prime Minister Denis Manturov said in October 2022 that the preliminary cost of creating ROS is already known, and the launch of the first scientific and energy module is scheduled for the end of 2027. The remaining modules, including the hub, gateway and base modules, will be launched until 2030, and the second phase of the deployment involves the docking of two target modules between 2031 and 2033.^[3]

Growth of public procurement of medical products and medicines by 7% to 1.15 million procedures

State purchases of medical products and drugs in Russia in 2023 increased by 7% compared to 2022 - to 1.15 million procedures. In the money, the supply of medicines, reagents, medical instruments and devices to state organizations increased by 1.8% and reached 2.12 trillion rubles. This is evidenced by the data of the service "Kontur. Bargaining," published at the end of March 2024.

According to RIA Novosti, citing Vasily Danilchik, an expert on the Kontur. Torgi service, the lion's share of medical public procurement still falls on drugs: in 2023, their sales reached 1.17 trillion rubles, which is 3% less than a year earlier. The number of closed procedures in terms of purchases of medical equipment and tools in 2023 increased by 14%, to 399 thousand purchases, and the amount of purchases - by 5%, to 596 billion rubles.

State purchases of medical products and drugs in Russia in 2023 increased by 7%

Vasily Danilchik also cited data according to which in 2023 the number of failed purchases for the supply of medical devices and drugs under both laws of 44-FZ and 223-FZ, in which there were no participants or all participants were not allowed, decreased by 4%, to 153 thousand procedures. This suggests that suppliers have become more active in applying for participation in procurement, the expert emphasized.

According to the estimates of the research company DSM Group, in 2023 the volume of the Russian pharmaceutical market decreased by 0.3% in rubles compared to 2022. In the state segment, only hospital purchases decreased in monetary terms - by 31%. Preferential drug provision (federal benefit) increased by 12%, regional benefit - by 10%. In physical terms, all segments of public procurement were reduced: hospital purchases decreased by 17%, federal benefits - by 9%, regional benefits - by 12%.^[4]

In the Sverdlovsk region launched the production of components for blood collection systems for 130 million rubles

The Medical Technology Plant has established a serial production of bilateral needles for taking venous blood with an imaging camera in Kamensk-Uralsky, Sverdlovsk Region. It is expected that this will allow the company to begin production of venous blood collection systems under the ZMT brand. This information was shared with Zdrav.Expert on October 25, 2023 by representatives of the Industrial Development Fund. Read more here.

Roszdravnadzor published a list of registered medical devices with artificial intelligence

In April 2023, the Federal Service for Supervision in Healthcare (Roszdravnadzor) published a list of registered medical devices (MI) based on artificial intelligence (AI) technologies. It is available on the portal of operational interaction of Uniform State Health Information System participants and will be constantly replenished with new MIs. Read more here.

License for TOMI according to the new rules: who needs to reissue and how to do it

According to the government decree, licenses for TOMI - maintenance of medical devices, issued before March 1, 2022, must be reissued according to the new rules until January 1, 2024. But from September 1, 2023 [1] , the new Decree will begin to operate# npa = 130755. Who it applies to, how to get it and what tools need to be used to meet the requirements - read the article at the link.

2022

Decline in sales of medical expenses by 1.4% to 20.8 billion units

The volume of the Russian market for consumable medical materials at the end of 2022 was estimated by BusinesStat analysts at 20.8 billion units, which is 1.4% less than a year ago. Sales of these products decreased due to the weakening demand for personal protective equipment, which has been celebrated since 2021, when the COVID-19 coronavirus pandemic began to recede. This is stated in a study published in December 2023.

According to analysts, before the pandemic, sales of medical consumables grew amid the rise of the commercial medicine market. Private clinics have gained particular popularity in the context of a decrease in the availability of medical care after a program to optimize public sector institutions. Commercial sector organizations actively purchased significant volumes of consumables for receiving patients and conducting medical procedures.

The largest sales of medical consumables were recorded in 2020, when the demand from the laboratory diagnostics sector, which tested the population for coronavirus, sharply increased. The volume of sales of consumables for the collection and study of biomaterial, as well as dressings used after blood sampling or injections, has significantly increased. In addition, the growth of the market was facilitated by the establishment of a mask regime - this led to an increase in demand for medical expenses in the retail sector.

According to the results of 2022, analysts named the following companies as the largest manufacturers of medical consumables in Russia (shares are not indicated):

• JSC "Vector-Best";
• Sintol Research and Production Company LLC;
• LLC "Medical Production Company" Yelets ";
• MedPol LLC;
• LLC "Enterprise" Fast^[5].

Growth in the production of dressings by 20.6% to 20.65 billion rubles

The volume of production of dressings in Russia in 2022 reached 20.65 billion rubles, which is 20.6% more than a year earlier. The market has been growing steadily for several years. This is evidenced by the data of analysts of the GuideMarket agency, which were published in mid-November 2023.

According to experts, from 2018 to 2022. the volume of the Russian market for dressings has approximately doubled largely due to an increase in the production of domestic funds from 558.3 million packages in 2018 to 1 billion units in 2022. If we exclude the impact of inflation on market dynamics, then in 2022 the market grew by 7%. The largest market growth rate, excluding inflation, was recorded in 2020 and amounted to 33.3%, experts say.

The leading federal district of the Russian Federation for the production of adhesive dressings is the Central Federal District (87.3% of production for the period from 2017 to 2022), in second place is the Siberian Federal District (12.7% of production).

The main raw materials for the production of hydrogels for wound care are chitosan, collagen, as well as individual raw materials for new types of plaster products, such as colloidal silver (used as an interlayer in plaster-type bandages), povidone iodine (used to impregnate a pad of adhesive pads) can be provided by Russian manufacturers (Moscow region, Leningrad region): "Naturing," "Green Dubrava," "Iodine Technologies and Marketing," "Luga Plant" Belkozin ', etc.

Base materials and "pillows" for strip patches and patch-type bandages, such as non-woven fabric, sorption pillows today can be partially provided by Russian manufacturers (Tula, Saratov, Chelyabinsk region): Shchekino-Azot, BalEnergomash, Sea-Ireland^[6]

The Ministry of Health of the Russian Federation named medical devices that are not produced in Russia and friendly countries

At the end of March 2022, the Ministry of Health of the Russian Federation named medical devices that are not produced in Russia and friendly countries. We are talking about more than 4.5 thousand items, which corresponds to almost half of the 9.7 thousand codes of types of medical products included in the state register.

More than 5 thousand registration certificates out of 31.5 thousand were received by manufacturers from Western states. Of these, 254 positions are critically important, said Igor Korobko, director of the Department of Science and Innovative Health Development of the Ministry of Health, at an online meeting of the Presidium of the Russian Academy of Sciences.

In the list of imported products:

• endoprostheses and their components used in traumatology-orthopedics; catheters and consumables for cardiovascular surgery and neurosurgery;
• devices, tools, components and consumables for endosurgery, anesthesiology-resuscitation, transplantology and dialysis.

There is also dependence on the procurement of medical equipment, especially heavy, demanded within the framework of the national project "Healthcare," Korobko noted.

The Ministry of Health has formed 20 working groups in various fields of medicine, which include the main freelance specialists, representatives of Roszdravnadzor, the Ministry of Industry and Trade and experts from the National Institute of Quality. Their task is to analyze the Russian industry market and give recommendations on the development of new areas of industry. Academic developments should "be quickly brought to practical application and take their place in meeting the critical needs of the country," Korobko emphasized in his address to scientists. For this, according to him, new MI registration regulations under conditions of sanctions pressure have been developed and are being approved, which create favorable conditions for domestic developers to bring their products to the market.^[7]

Mishustin lifted all restrictions on the purchase of various medical devices in one lot

In March 2022, Prime Minister Mikhail Mishustin signed a decree that lifted all restrictions on the purchase of various medical devices in one lot. This measure is temporary and is being introduced to support health care in the face of Western sanctions.

Suspend until September 1, 2022 the Decree of the Government of the Russian Federation of April 19, 2021 No. 620 "On the requirement for the formation of lots in the procurement of medical devices that are the object of purchase to meet state and municipal needs" (Collection of Legislation of the Russian Federation, 2021, No. 17, Art. 2986), - said in a document signed by Mishustin.

The ban on combining different names of medical devices into one lot or contract was introduced in July 2021. The exception was procurement under life cycle contracts (LCC), as well as the purchase of medical equipment with consumables provided by the manufacturer.

In addition, the restrictions did not apply to small purchases: up to 600 thousand, 1 million and 1.5 million rubles, depending on the volume of medical equipment purchased during the year, that is, in the amount of less than 50 million rubles, 50-100 million rubles, more than 100 million rubles, respectively. In case of exceeding the limit, the unification of medical products different in terms of nomenclature was prohibited.

In March 2022, the Ministry of Industry and Trade of the Russian Federation announced a revision of restrictions on the formation of lots. The agency intended to allow the combination of different types of medical equipment into one lot, subject to a comprehensive purchase for equipping clinics or departments under construction that have not yet received a license for medical activities, understaffing previously purchased sets of medical devices, as well as in the case of purchases of disposable gloves.

Decree of the Government of the Russian Federation of March 16, 2022 No. 374

Mishustin allowed hospitals to quickly purchase medical devices

In March 2022, Prime Minister Mikhail Mishustin signed a decree that expanded procurement opportunities for clinics and hospitals. According to the document, medical institutions operating under the compulsory health insurance system (Compulsory Medical Insurance Campus Management) will be able to procure drugs and medical devices at an accelerated pace due to a significant increase in advance payments for medical care.

As noted in the Cabinet, earlier the monthly advance payment of hospitals and clinics could not exceed 1/12 of the amount, now hospitals and clinics operating under the compulsory health insurance system will be able to receive an advance payment in the amount of no higher than all annual funding.

In addition, the Government of the Russian Federation has simplified the procurement procedure: until September 1, 2022, medical institutions will not have to divide such purchases into separate lots for each type of medical devices. As indicated in the Cabinet, these changes will speed up the purchase of medicines, the renewal of hospital equipment and, in general, improve the quality of medical care.

The Cabinet of Ministers summarized that thus, by mid-March 2022, work continues to improve the stability of the market for socially significant services, which was influenced by the consequences of sanctions. Earlier, Mikhail Mishustin said that medical products in Russia should remain available for hospitals and clinics even in the event of a rise in price due to outside restrictions.

Earlier in March 2021, the Russian government introduced a temporary ban on the export of foreign medical devices delivered from countries that have imposed sanctions. The cockpit believes that the measures taken will help prevent a shortage of such products in Russia. By March 18, 2022, many large foreign manufacturers of medical products announced their intention to continue their activities in Russia.^[8]

Mishustin, after a request from Medtronic, expanded the list of implants available for compulsory medical insurance

In mid-January 2022, Prime Minister Mikhail Mishustin signed a decree of the Government of the Russian Federation, which expanded the list of implantable medical devices within the framework of the Campus Management compulsory medical insurance program.

The updated list includes:

• cardiac aortic valve bioprosthesis/aortic prosthesis made of xenomaterial - it is used to provide specialized medical care to patients with cardiovascular diseases, in particular with congenital aortic valve stenosis;
• synthetic material for vascular embolization - used in the provision of high-tech care for patients with benign prostatic hyperplasia and postpartum bleeding;
• pulse generator of implanted urinary and stool incontinence control system by electrostimulation.

All products are manufactured by Medtronic. They are registered by Roszdravnadzor under the brands "Freestyle aortic valve bioprosthesis," "Onyx liquid embolizing system (LES)" and "InterStim II neurostimulator." In December 2021, the Commission of the Ministry of Health of the Russian Federation on the formation of lists of medical devices considered 14 applications for inclusion in the list of implantable devices, of which 11 were declared by Medtronic, another application was received from Elta Company LLC, Medtehservice LLC and NTI Helsnet LLC.

Some medical products were rejected for reasons of non-compliance with the class of implantable products and nomenclature classification codes, inability to meet the need due to insufficient production of the declared medical products and the need for additional budget expenditures.

In accordance with the document signed by Mikhail Mishustin, the list of implantable medical devices that are available to citizens free of charge under the compulsory medical insurance program has been increased to 375 items. The Cabinet noted that the innovation will increase the availability of expensive medical devices for patients who need special treatment.^[9]

2021

FAS revealed the largest cartel in the Russian Federation on the market of medical products

Federal Antimonopoly Service (FAS) revealed the largest Russia in the cartel in the medical device market. The regulator announced this on September 13, 2021.

The Office of the Federal Antimonopoly Service (OFAS) in Ingushetia has been investigating the conspiracy for almost two years, which affected about 7,000 purchases in the medical device market, said the head of the department Batyr Tochiev. The violators were Medspb, Optomed, Prime, as well as several individual entrepreneurs.

According to the FAS, as a result of the conspiracy, thousands of state contracts were concluded for the purchase of injection needles, disposable syringes and systems for blood transfusion at maximum prices, if possible to optimize them. The actions of the bidders could lead to an unreasonable increase in prices for medical products, as well as to a decrease in the volume of purchased products.

It is noted that the checks were carried out with the support of law enforcement agencies, since the organizations obstructed the employees of the department.

The antimonopoly authority found that the actions of the bidders were coordinated by the manufacturer of medical devices LLC MPK Yelets. At the same time, the conspiracy was implemented using state preferences to organizations - manufacturers of domestic products.

Participants in the conspiracy used the "third extra" rule. It is used in cases where two of the participants are manufacturers of Russian goods, and the rest are suppliers of foreign products. Imitating competition, they submitted two mutually agreed proposals. Thanks to this, the applications of the remaining participants were rejected, and the allies of the conspiracy divided the state contracts among themselves.

At the same time, the participants in the conspiracy appealed to the antimonopoly authorities, abusing the right to file complaints against competing organizations. In the complaints, the participants in the conspiracy indicated that the customers did not use the "third extra" rule. At the same time, in the absence of collusion, they could not know about the content of the applications of other bidders.^[10]

10 typical errors in obtaining permits to import medical products

In June 2021, the Federal Service for Supervision of Healthcare (Roszdravnadzor) published a list of 10 typical errors that arise when obtaining permits for the import of medical devices:

• errors during filling of MI configuration. As an example, the service cites a situation where the equipment and accessories fit into the name of the medical device;
• discrepancies of information on the applicant with the given USRLE and the Unified State Register of Individual Entrepreneurs. The documents incorrectly indicate the TIN, OGRN, OGRNIP, the name of the organization, the name of the general director;
• no power of attorney for the person who signed the application or contract for conducting the tests;
• inconsistency of data in sent documents. We are talking about non-compliance of the names, quantity, batch numbers, etc. specified in the application with what is specified in the test contract;

• the absence of a Russian-language version of the name of medical devices or imported samples;
• expired contract/power of attorney or no date for drawing up the document;
• use of the wording "if necessary" instead of specifying a specific number of imported samples;
• filing an application in the presence of a previously issued permit for the import of medical products. The service clarifies that if it is necessary to import additional samples of MI, an explanatory letter should be included in the set of documents, in case of an error in submitting an application, an application to cancel the previous permit;
• errors when submitting a copy of the document confirming the authority of the authorized representative of the manufacturer. A problem arises when the applicant provides a document that is not duly certified or does not provide its certified translation into Russian;
• the absence of an indication in the document confirming the authority of the authorized representative of the manufacturer to represent the interests "on the circulation of medical devices in the territory of the Russian Federation."^[11]

The Ministry of Industry and Trade signed a contract for the promotion of Russian medical products in the media and social networks

In April 2021, the S-Group Corporate Communications Center won the tender of the Ministry of Industry and Trade for the promotion of Russian medical devices in the Russian Federation and abroad from 2021 to 2023. The initial contract price was 300 million rubles. The winning company was the only participant in the competition, it offered 291 million rubles. Read more here.

2020

The Russian market for medical devices sank by 5%

The volume of the Russian market for medical devices in 2020 decreased to 289.8 billion rubles from 304.9 billion rubles a year earlier (a decline of 5%). Sales of such products in the Russian Federation amounted to 1.3% of the world volume, according to the data of the Meditex medical industry competence center.

According to experts, despite the fall in volumes in most segments of the medical equipment market, the share of segments of medical devices for resuscitation, laboratory (in-vitro) diagnostics and general hospital equipment has significantly increased.

As for the export of medical devices, most of it in 2020 fell on masks, breathing equipment, thermometers, X-ray diagnostics equipment, defibrillators and blood transfusion equipment. The share of imports of medical products, compared to 2019, decreased by 6.5%.

The leaders in terms of export volumes were X-ray diagnostic equipment produced in Moscow, defibrillators, blood transfusion equipment, electronic thermostats, pressure gauges and dental devices. Key enterprises are Aktubrengten, Amiko, Biss and S.P. Gelpik, which produces radiological equipment and defibrillators. The largest customers of medical products in the region were India, Bulgaria, Armenia and the UAE.

As noted in the study, the experience of the COVID-19 coronavirus pandemic clearly demonstrated the need to increase costs not only for healthcare, but also for medical developments to increase the production of competitive medical equipment. According to experts, in 2021, the medical industry in Russia may not only recover, but also grow by 5-6% in relation to 2020.

According to the data, Rosstat the production of equipment and devices used for medical purposes for diagnostics, radiation, rehabilitation and therapy in 2020 reached 34.4 billion rubles, an increase of almost 35% compared to the previous year.^[12]

State purchases of imported medical masks in Russia banned until the end of 2021

At the end of December 2020, Prime Minister Mikhail Mishustin signed a government decree that prohibits state purchases of imported medical masks for one year.

To establish that the prohibitions established by paragraphs 1 and 2 of this resolution [ban on the admission of imported goods to public procurement and procurement for defense and security needs, respectively. note - Zdrav.expert], in relation to medical masks indicated in paragraphs 123 and 126 of the list, are valid until December 31, 2021, - said in a document published on the official Internet portal of legal information.

Thus, the Government of the Russian Federation amends the decree of April 30, 2020, which prohibited the admission of imported industrial goods to purchases for state and municipal needs, as well as to purchases for the needs of defense and state security.

The initiative to ban state purchases of foreign medical masks, except for those produced in the EAEU countries in early November 2020, was made by the Ministry of Industry and Trade. The agency has developed a corresponding draft government decree, which indicated that some enterprises were forced to stop producing protective and medical masks due to lack of demand. The document also says that the adoption of such restrictions will contribute to "maintaining the increased production capacity of domestic enterprises after the end of the fight against the spread of the new coronavirus COVID-19 infection."

During the big conference, which was held on December 17, 2020, President Vladimir Putin said that at that time about 150 thousand doctors and more than 500 thousand medical workers in general participated in the fight against COVID-19. The production of masks has grown 20 times, the head of state said then.^[13]"

The Ministry of Health approved the procedure for the import of medical devices for registration in Russia

At the end of September 2020, the Ministry of Health of the Russian Federation approved the procedure for importing medical devices for registration in Russia.

According to the new rules, permission Roszdravnadzor to state registration of medical products when importing them into the Russian Federation from January 1, 2020 can only be issued electronically - a special service has been launched on the agency's website, through which an application can already be submitted.

From January 1, 2021, permission from Roszdravnadzor will be required for all imported medical devices, except for software. It should be received, including those manufacturers who are registered in Russia, but produce goods abroad.

According to the regulations, within five working days from the moment of appeal, it will go to the applicant's personal account on the website of public services, signed by an enhanced electronic signature of Roszdravnadzor. The validity period of the document has been increased from 6 to 12 months, but they are still granted the right to only a single import of a medical product into the country for state registration.

Within two days after registration, information about it will also appear in the Register of issued permits in the automated information system of Roszdravnadzor, where only an open part of information that is not protected by the law on commercial secrets is subject to placement.

The reason for the refusal may be the failure to provide information in full or their erroneity, the restriction of the import of medical products by decision of the Government of the Russian Federation or an international treaty, as well as the presence of Roszdravnadzor information about undesirable and side effects not indicated in the documents for the medical device. There is no fee for issuing a permit to import medical devices.

On January 1, 2021, Order of the Ministry of Health of Russia No. 7n of 15.06.2012 "On Approval of the Procedure for the Import of Medical Devices into the Territory of the Russian Federation for State Registration" will lose force. ^[14]

Russian medical products will have advantages in state registration

On September 21, 2020, it became known that Russian medical devices will receive advantages during state registration. The corresponding amendments to Government Decree No. 1416 of December 27, 2012, regulating the procedure for state registration of medical products in the Russian Federation, were introduced by the Ministry of Health of the Russian Federation.

According to the agency's initiative, a one-stage procedure for registering domestic high-tech medical devices is being introduced, along with medical devices of the 1st risk class and used for in vitro diagnostics. The nomenclature list of specific MI names that will receive the benefit will be formed by the Ministry of Industry and Trade in agreement with Roszdravnadzor.

The duration of the registration procedure for such MIs is 32-112 working days, while for products not intended for in vitro diagnostics and having a potential risk class of use above 1, the period reaches 50-180 days. Making changes to the registration rules in favor of domestic manufacturers will help significantly reduce the period of state registration of their products, the report says.

According to the explanatory note to the document of the Ministry of Health, the amendments were developed on behalf of Deputy Prime Minister Tatyana Golikova dated July 27, 2020 and are designed to reduce the time for state registration of domestic medical devices.

Earlier in 2020, the Russian Government approved a list of medical devices of 36 items, in respect of which a special procedure for state registration in the country is established. Among them are insulating and surgical suits, insulating and operating gowns, surgical and viewing clothing sets, masks, shoe covers, respirators and gloves. The simplified permanent state registration of medical products was included in the National Plan for Economic Recovery of the Russian Federation in May 2020.^[15]

Manufacturers of medical devices to combat coronavirus in Russia will be given loans at 1%

In early April 2020, it became known that manufacturers of medical devices and drugs designed to combat the COVID-19 coronavirus in Russia will be given loans at 1% per annum. The corresponding program was launched by the Industrial Development Fund (FRP). The volume of loans will be from 50 million to 500 million rubles. 

The support measure will be aimed primarily at financing companies that produce equipment and products for the detection, prevention and treatment of epidemic diseases, as well as producing personal protective equipment, medicines and medical devices.

The program is implemented in the form of granting concessional loans for up to two years to replenish working capital for the purchase of raw materials, materials and components, the purchase of critical finished products abroad, as well as the purchase of equipment.

The new program of the Industrial Development Fund is extremely timely and aimed at supporting manufacturers of medical equipment, as well as medical devices and drugs involved in the fight against  the COVID-19 coronavirus infection pandemic, said Alexey Fursin, head of the Department of Entrepreneurship and Innovative Development.

It is noted that co-financing is not required under the program, and consideration of applicant projects is carried out in an accelerated mode (no more than four days, a simplified package of documents, the possibility of obtaining a loan only under the guarantee of beneficial owners and the head of the company).

Earlier, the Government of the Russian Federation allocated 10 billion rubles from the reserve fund for these purposes. The regions are also introducing their own measures to support manufacturers. In early April 2020, the Government of the Moscow Region promised to compensate manufacturers of medical masks and disinfectants for up to 80% of equipment costs.^[16]

Ban on the export of masks and other medical devices from Russia

In early March 2020, the Russian Government banned the export of masks and other medical devices from the country "in order to protect the interests of Russian citizens," according to the relevant decree.

Restrictions apply to masks, bandages, gauze, cotton wool, especially durable shoe covers, disinfectants and antivirals, gloves, chemical protection suits, anti-plague suits, respirators, goggles, medical gowns, etc.

At the same time, the innovation does not apply to cases when these medical devices are sent abroad as part of international humanitarian assistance, as well as in the case of the export of disposable items for personal use.

According to the head of the Ministry of Industry and Trade Denis Manturov, the government's temporary ban on the export of medical masks from Russia is aimed at combating speculators: some people buy medical products in Russian pharmacies and take them out for sale abroad.

At the end of February 2020, Rospotrebnadzor recommended that retail chains stock up on medical masks and other products in order to prevent the spread of coronavirus. According to the recommendations of the department, a stock of masks is needed in case of "further instructions on their use."

World Health Organization (WHO) Director General Tedros Gebreisus said during a briefing that tens of millions of medical masks are needed to protect against coronavirus every month.

According to the Ministry of Industry and Trade, by February 2020, Russian manufacturers produce 1.2 million medical masks per day, which fully covers the needs of the country. 20 manufacturers are engaged in their production, including the three largest enterprises, which produce about 900 thousand masks per day. Denis Manturov said that if necessary, the production of masks can be increased to 1.4-1.5 million pieces per day.^[17]

2019

The Russian market for medical products grew by 6% and amounted to 1.5% of the world

According to the estimates of the Meditex Scientific and Technical Center, the volume of the Russian market for medical devices in 2019 reached 304.9 billion rubles, an increase of 6% compared to 2018. The Russian Federation accounted for about 1.5% of sales of such products in the world.

As the study notes, medical device manufacturing is a critical and rapidly growing segment of the healthcare industry. By 2019, the industry's manufacturing companies have achieved serious technological achievements and have grown exponentially. Despite tight regulation and financial pressure on the industry, the market continues to grow both in Russia and around the world. In 2019, sales of medical devices on a global scale increased to $425 billion, and by 2025 the figure could rise to $612.7 billion.

An important result of 2019 on the Russian market of medical products in Meditex is called the start of sales of localized products at several enterprises. In addition, new strategic partnership agreements were signed between Russian and foreign companies.

The Russian government has actively taken measures and laws aimed at protecting, supporting and developing domestic production, which at the same time do not limit the possibility of technology transfer, stimulate the localization of foreign production and the development of projects involving foreign investments. This in turn makes it possible for experts to predict an increase in the growth rate of the medical devices market in Russia.

In 2019, a list of medical equipment was developed to re-equip clinics under the Healthcare national project.

The list for re-equipment of clinics under the oncological program of the national project includes 147 units of medical devices, including CT, MRI, PET, angiographs, brachytherapy devices, various X-ray equipment and several varieties of ultrasound scanners. The list also includes a line for clinical and laboratory diagnostics, which includes several types of analyzers.^[18]

State purchases of medical products in the Russian Federation increased by 16.6%

State purchases of medical devices in Russia at the end of 2019 reached 355.6 billion rubles, an increase of 16.6% compared to the previous year. On average, one distributor delivered in the amount of 11 million rubles. This is evidenced by data from the Vademecum analytical center.

According to experts, the total result of the 100 largest suppliers of medical products under state orders in 2019 practically did not change and amounted to a little more than 97 billion rubles. At the same time, in connection with the implementation of the national project "Healthcare" and local projects, the balance of power in the rating has changed dramatically.

As reported in the study, the "strong middle peasants" demonstrated the greatest activity in the tender market - a total of 698 companies showed revenue from 100 million rubles in 2019. At the same time, the threshold for entering the top 100 increased by 40 million rubles and reached 402 million rubles.

As in all previous years, the trends in the market were set by the Moscow Department of Health (DZM). However, it was in 2019 that key suppliers of DZM during the time of Leonid Pechatnikov, who first headed and then oversaw the work of the department as vice mayor for social development, were pushed away from the leading positions.

Aquista flew out of TOP-100 (7.8 billion rubles in 2018) outside the first thousand (60 million rubles in 2019). "Tagore" from second place (7.7 billion rubles) dropped to 1823 (42 million rubles), "Viking" - from the seventh line (2.2 billion rubles) to 134th (181.5 million rubles).

The first position in the rating was taken by Gemamed (the volume of contracts in 2019 is 9.41 billion rubles), specializing in the supply of stoma care products, accessories and skin and wound care products, including a line of calo and uropodians manufactured by the Danish Coloplast. Delrus in 2019 rose to second place with 7.65 billion rubles, and Irvin closed the leading three (3.3 billion rubles).TOP100 OF SUPPLIERS OF THE STATE ORDER MARKET FOR MEDICAL DEVICES IN 2019

2018

Market growth by 1.5 times - up to 280.9 billion rubles

The volume of the Russian market for medical devices in 2018 reached 280.9 billion rubles, which is one and a half times more than in 2014. This is evidenced by the results of the audit conducted by the Accounts Chamber of measures of state support for the healthcare industry.

According to the ministry, domestic manufacturers in 2018 accounted for 24.3% of public procurement of medical products against 20.9% four years earlier. Budget expenditures to support the medical industry in 2014-2018 exceeded 21 billion rubles, and the Industry Development Fund sent more than 2.8 billion rubles for the development of the industry.

Executive Director of the Medresurs Union Natalya Rozanchugova connects the growth of the medical products market in 2014-2018 with the devaluation of the ruble and explains that most of the products are produced by foreign manufacturers. If we do not take into account the currency factor, the market did not show significant growth largely because the number of names of goods is decreasing, she noted.

According to the Accounts Chamber, one of the factors that restrains the development of the market is the delay in the registration of new medical products developed within the framework of R&D when they enter the market. For example, by May 2019, registration certificates did not receive medical products developed under 75 contracts of 2017. However, as the auditors say, during the joint board, the Ministry of Health promised to prepare a bill that should speed up the procedure for registering high-tech medical equipment.

The auditors also noted that the Ministry of Industry and Trade did not comply with certain provisions of the rules for providing subsidies and the risks of non-fulfillment or delay in the implementation of the import substitution action plan in the medical industry for 31 products (technologies).

Auditor Sergei Agaptsov pointed out the risks of "the Ministry of Industry and Trade forming inaccurate official statistical information" due to the low discipline of manufacturers. Only a third of the 2.95 thousand companies provided the department with a report on the release and sale of their products by May 2019.

The volume of the market could not be clarified by the data received by the Ministry of Industry and Trade from companies, but the error is unlikely to be more than 10-15%, says Andrey Vilensky, head of Meditex.^[19]

Draft Strategy for the Development of the Russian Copper Industry until 2030

As it became known on August 15, 2018, in order to ensure further growth of the industry, the Ministry of Industry and Trade of the Russian Federation developed a draft Strategy for the Development of the Medical Industry of Russia until 2030 - the corresponding document was published on the portal gasu.gov.ru. The main goals of the strategy are to increase the production of Russian medical products by 3.5 times by 2030, a tenfold increase in export supplies and the registration of at least 100 new Russian-made medical devices annually starting in 2019.

The authors of the document proposed as measures to support the industry until 2030:

• Organization of clusters, industrial parks, technology parks to consolidate the efforts of medium and small businesses.

• Ensuring state support for the development and production of critical types of medical products, their promotion and commercialization.

• Speed up the registration and launch of medical products on the market in such a way as to achieve registration of at least 100 units of products per year by 2030.

• Cancellation of the zero VAT rate for medical products in order to equalize the price competitiveness of domestic medical products that are made from taxable imported components.

• Stimulating foreign players to localize not only industries, but also engineering centers with the help of tax incentives and preferences.

• Stimulating the consumption of domestic medical products by: increasing the responsibility of state customers, forming requirements for TORs at tenders "to ensure the equality of Russian and foreign players" and expanding the list of medical products subject to the "Third Extra" rule.

• Introduction of the status of a supplier of Russian goods for manufacturers, leasing and distribution companies. Create supplier associations to "structure demand." Thus, the authors of the document believe, it is possible to "grow" national integrators. As of August 2018, the 25 largest distributors occupy 15% of the government order market.

• Transition to centralized purchases of leasing services, involving the supply of equipment and its maintenance within up to 6 years.

Discussion of the submitted project will last until September 15, 2018.^[20]

The share of domestic medical products in Russia increased to 21%

In April 2018, the Minister of Industry and Trade of the Russian Federation Denis Manturov met with representatives of leading developers of medical devices and held a meeting on breakthrough technologies to meet the needs of domestic medicine.

" Within the framework of the sectoral state program (" Development of the pharmaceutical and medical industry " for 2013-2020 ") over the previous 5 years, the implementation of more than 160 projects on medical devices has been financed , - shared the head of the Ministry of Industry and Trade of Russia "There are specific results, product samples , and the most breakthrough ones  will be presented at our meeting."

The Minister noted that the support measures implemented by the Russian Government significantly increased the competitiveness of Russian manufacturers, which made it possible to increase the share of domestic products on the market ( in 2014 - 18.2%, in 2017 - 21.0%).

"I would like to note that  at present we are updating the current strategy for the development of the medical industry (until 2020 ) and summing up the preliminary results of its implementation. Of course , it is important for us to hear the opinion of doctors as direct consumers of the products being created , "concluded Denis Manturov

.

 During the meeting, a number of developments were presented to the head of the department. Including :

• Director General of the Federal State Budgetary Institution "National Medical Research Center for Cardiology of Radiology" of the Ministry of Health of Russia Andrei Kaprin spoke about the developed installation of clinical placement intended for high-precision radiation therapy of cancer patients with a low load on healthy tissues;

•    Ivan Ozhgikhin, Deputy General Director for Development of Sales, Marketing and Service Support Systems for Civilian Products of Shvabe JSC, on  developed mobile medical complexes for precision diagnostics of cancer and Rehabric rehabilitation system;

•  Igor Ledovoy, General Director  of Equality JSC, presented the developed gamma-therapeutic technique and components for its configuration;

•  Anatoly Dabagov, General Director of Medical Technologies Ltd JSC, developed high-tech medical equipment Mammo-5MT and Diarm-MT;

• General Director of CJSC "Research Production Company" Electron "Alexander Elinson presented the developed apparatus for three-dimensional research of the foot and imaging system" SVR "with a line of equipment, as well as complex IT solutions for phthisiology;

•   Sergey Evdokimov, General Director of NPP MedInzh CJSC , developed rigid and flexible valve prostheses hearts  with open central flow, combined with a miniinvasive implantation system and cardiovascular implants made of artificial and biological materials with transcatheter delivery systems;

•  Irina Zhukovskaya, General Director of Lintex LLC , is a project of a technological complex for the production of absorbable synthetic materials and medical devices based on them ;

•  Vladimir Kolin, General Director of DNA Technology LLC, made a presentation on the developed automated PCR complex and other diagnostic tools  , and Artem Kuznetsov, Chairman of the Board of Directors of RK-Stroy LLC, spoke about the developed TECont and controlling the main cardiovascular risks based on a smartphone with an application.

Holding such a meeting made it possible to assess the possibility of the earliest possible use of new, modern equipment in medical institutions in Russia^[21].

SmithHelskea will build a medical products plant in St. Petersburg

On April 3, 2018, SmithHelskea announced the start of design of an enterprise for the development and production of medical devices and medical equipment at the site of the Novoorlovskaya Special Economic Zone (St. Petersburg). The company plans to start directly to the construction of a factory of medical devices and equipment under its own brand at the beginning of 2019. It is planned to invest 915.4 million rubles in the project . Read more here.

2017

The volume of the medical products market reached 255 billion rubles

According to the Ministry of Industry and Trade of the Russian Federation for 2017, the market volume of medical devices in Russia amounted to 255 billion rubles, of which 23 billion rubles fell on medical devices for diagnostics and 10 billion on products for surgery. At the same time, the share of domestic products at the end of 2017 reached 21% - since 2011, this figure has increased by 4.2 percentage points. The volume of exports of Russian medical products, a third of which falls on neighboring countries, amounted to 3.9 billion rubles (or 7% of production).

According to representatives of the department, the increase in the share of domestic products was the result of the work of the program document - "Strategy 2020." Nevertheless, the actual indicators of the industry turned out to be lower than those announced by the program, follows from the document. In particular, the share of the medical industry in GDP amounted to 0.6% instead of the planned 0.11%, the share of Russian medical products in the domestic market amounted to 21% instead of the expected 28%, the planned share of exports from local production reached 7% instead of the estimated 10%, and the share of companies "implementing technological innovations" decreased to 25% instead of planned growth to 41%.^[22]

The "systemic problems and restrictions" still persisting in the industry - a shortage of financing and personnel, as well as a long registration of medical products and an uneven and unstable demand of the main customers - state customers, could prevent reaching the targets, according to the Ministry of Industry and Trade. Among the external negative factors in the ministry were called fluctuations in the course of the national currency and restrictions on the import of components.^[23]

Dispute "Viroban" with the Ministry of Industry and Trade on the composition of the register of suppliers of medical products made of PVC

As it became known at the end of October 2017, Viroban, a manufacturer of medical products made of polyvinyl chloride (PVC), intends to challenge the decision of the Ministry of Industry and Trade to include in the domestic register of suppliers of medical products made of PVC plastics only one company - Medpolymerprom Group of Companies. According to Viroban, the requirements for potential registry participants initially predetermined the results of the selection. Read more here.

Cartels of suppliers of medical products totaling 18.5 billion rubles have been identified.

at the FAS Russia end of October 2017, she opened a case of cartel conspiracy of medical device suppliers. ZetMed LLC, OMT LLC, Ornel LLC and an individual entrepreneur who took part in public procurement for the supply of endoprostheses, implants for osteosynthesis, consumables for traumatology and other medical devices are suspected of concluding and implementing an anticompetitive agreement in the amount of about 1 billion. rubles

According to the antimonopoly service, the auction, which took place in the period from 2015 to 2017. on the territory of 11 constituent entities of the Russian Federation, ended with a minimum decrease in the initial price of contracts. During the specified period, cartels were identified in 82 regions of the Russian Federation within the framework of 185 auctions. The total amount of initial (maximum) contract prices exceeded 18.5 billion rubles.

Anticompetitive agreements apply to almost all pharmaceutical groups of drugs, as well as to all types of medical products. Dozens of manufacturers, official distributors and customers became participants in anti-competitive agreements. During the inspections, signs of corruption of officials of medical institutions were found. A number of business entities have already admitted to participating in the cartel, the FAS said in a statement.

The materials were transferred to law enforcement agencies to resolve the issue of initiating criminal cases.

As the head of the Department for Combating Cartels of the FAS Russia Andrei Tenishev noted: "The identification and suppression of cartels for the supply of medical devices is one of the priority areas of our work, since these issues are of serious public importance, especially in areas such as the health of citizens."

VAT exemption for vital products

On May 3, 2017, the Government of the Russian Federation approved the draft amendments to the Tax Code in terms of exemption from VAT of essential and vital medical devices. The corresponding order of Prime Minister Dmitry Medvedev was published on the website of the Cabinet. The document was reviewed and approved at a government meeting on April 27, 2017.

In order to equalize the conditions of taxation, the bill proposes to exempt from VAT the operations for the sale of services for the transfer of essential and vital medical devices with an appropriate registration certificate under financial lease (leasing) agreements with the right to redeem , "the document says[24]

It is worth noting that the sale of the most important and vital medical devices was exempted from VAT back in 2015. However, since then, operations on their transfer under lease agreements with subsequent redemption were still taxed.

We are talking about medical products that were included in the list of means used to prevent disability or rehabilitation of disabled people, a list of the most important and vital medical equipment, a list of lenses and frames for glasses.

As the professor told the Regnum news agency. Head of the Department of Accounting and Taxation of the PRUE named after Plekhanova Lyudmila Tchaikovskaya, tax exemption of financial lease services for essential and vital medical devices for ordinary people will be expressed in such effects as the development of the production of medical devices, improving the quality of life of people with disabilities and their employment, increasing the level of care for disabled people (diagnostics, prosthetics , etc.) and cheaper production of vital medical devices.

Ordinary citizens will finally begin to forget about the queues for important medical care - it costs a lot not just because it will make life easier, but in a sense it will "restart" people's attitude to the quality of their lives, to their own effectiveness and this is not only a moral, but also economic effect, - explained Tchaikovskaya.[25]

2015: Market volume of medical products 270 billion rubles

The total volume of the Russian market for medical products is about 270 billion rubles (as of 2015). At the same time, the niche is filled in the country by no more than 10%, - said Elena Plyasunova, head of Medtronic in Russia in March 2017. - For example, in some European countries, the frequency of stenting in patients with myocardial infarction reaches 90%, in the USA - 60% of patients. In Russia, in 2013, only 7.1% of patients with acute coronary syndrome received stenting. The potential of this niche for growth, according to our estimates, is huge.

2014: Russia joins Minamata Mercury Convention

In 2014, Russia joined the Minamata Convention on Mercury. The convention prohibits the production, export and import of mercury devices from 2020. In this regard, in 2020, prices for mercury thermometers remaining in pharmacies in the Russian Federation increased several times.

Notes