Import substitution of medical devices

Domestic production

Russian Medical Industry, 2019

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.

2024

Ministry of Health: hospitals in the Russian Federation are 60% equipped with domestic medical equipment

Hospitals in the Russian Federation are 60% equipped with domestic medical equipment. The minister health care Russia Mikhail Murashko told about this in mid-October 2024.

According to the head of the Ministry of Health, about 236 thousand units of medical equipment were delivered in 5 years. As part of further planning, 174 billion rubles will be allocated for 59 large healthcare facilities, 650 billion rubles for the development of infrastructure, including the modernization of primary care, Murashko added.

For manufacturers of nutrient media and wheelchair seats in Russia, a point assessment system was introduced

The Government of the Russian Federation has established point criteria for assessing the degree of localization of electrically driven wheelchair seats, as well as ready-made nutrient media intended for growing microorganisms. This was reported on May 13, 2024 by the Medvestnik edition.

According to the changes made to Government Decree No. 719 of 17.01.2015, in order to recognize nutrient media as domestic, it is necessary that the following operations take place on the territory of Russia:

• cooking - 30 points;
• spill (packing) - 20 points;
• sterilization - 30 points;
• mixing - 20 points.

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To confirm localization, the manufacturer must score a minimum of 60 points. In addition, the legal entity is obliged to have the rights to technical and design documentation for a period of at least five years. The manufacturer shall have structural subdivisions or laboratories responsible for product quality inspection during the warranty shelf life.

To fix the degree of localization of electrically driven wheelchairs, the manufacturer must confirm the legality of the use of technical documentation for the product. The ratio of domestic and foreign raw materials in production will also be taken into account. The percentage share of the cost of used foreign raw materials should be no more than 50%, and by 2028 - no more than 40%.

For the first time, a point system for assessing the domesticity of the production of medical devices was introduced by the Government in December 2022. Initially, 24 categories of products were included, later 18 more categories were added to the list, including tomographs, mammographs, APCs for recording X-ray images and ultrasound machines. The proposed system is designed to reduce Russia's dependence on imports of medical products and contribute to the country's scientific and technical potential.^[1]

2023

The Government of the Russian Federation banned state purchases of foreign ventilators

Prime Minister RFMikhail Mishustin signed a decree banning state purchases of some types of devices for artificial ventilation of the lungs (IVL) of foreign production. The corresponding document was published on the official portal of legal acts on December 15, 2023. Read more here.

The share of Russian medical equipment purchased by polyclinics for the first time exceeded 50%

More than half of the medical equipment purchased for Russian clinics is produced by Russian companies. This was announced on December 5, 2023 by Minister of Health Mikhail Murashko during a speech at the opening of the forum "Russian Health Week - 2023" and the XV All-Russian Congress of Pharmaceutical and Medical Industry Workers. It is noted that the share of Russian medical equipment purchased by polyclinics exceeded 50% for the first time.

We have almost doubled the list<...>, in my opinion, for medical devices that are supplied to medical organizations of a polyclinic profile. Plus, we had good savings and an increase in the volume of purchased equipment, - added the minister (quoted by TASS).

More than half of the medical equipment purchased for Russian clinics is produced by Russian companies

According to Murashko, at the beginning of the work of the program for the modernization of primary health care, which started on January 1, 2021, the share of supplies of domestic equipment to clinics was at the level of 20%. Not only the share has increased, but also the variety of equipment - the list of products supplied in the clinic has doubled. In addition, the minister emphasized the need for manufacturers to cooperate with regional medical organizations, federal institutions and chief medical specialists in their fields, since the products must meet expectations and be suitable for medical personnel.

In 2022, the Ministry of Industry and Trade set a goal to achieve a 50% share of domestic products in the field of medical equipment in 2023-2024. and grow to 80% by 2030.

The task is to increase the share of domestic medical equipment on the market to 50% in two years and to 80% by 2030. To achieve these ambitious indicators, the Ministry of Industry and Trade of Russia is ready to support the enterprises of the industry - said then Denis Manturov, Minister of Industry and Trade of Russia.[2]

Mishustin banned the purchase of imported tubes for state needs

In September 2023, Prime Minister Mikhail Mishustin signed a decree restricting state purchases of foreign vacuum tubes for taking blood samples. The changes are associated with an increase in the production capacity of Russian manufacturers, the Ministry of Industry and Trade explained.

Today, they allow you to cover the need for the health care system, while not reducing the quality of medical care provided to citizens, the department said.

Limited government purchases of foreign vacuum tubes for blood samples

As assured in the Ministry of Industry and Trade, the government decree will expand the production potential of Russian enterprises and bring Russian products to the markets at acceptable prices. The ministry also drew attention to the fact that by the time the document enters into force in December 2023, all participants in the contract system will be able to systematically switch to the application of these changes.

Earlier in 2023, the Government of the Russian Federation has already excluded a number of vacuum tubes from the "third extra" list and added to the list resolution No. 616, which prohibits the purchase of imported goods for state needs. Now several more types of vacuum tubes for taking IVD blood samples have been added to the list. We are talking about such NKMI codes as 293370, 293420, 293500, 293570, 293660, 334330.

In addition, in September 2023, changes were made to the procedure for quotas for the purchase of domestic medical products. In Decree No. 2013, which sets quotas for the purchase of domestic medical products for 223-FZ, the indicators for 2023 for supplies for mechanical ventilation and blood transfusion, SPECT and gamma cameras were canceled, but surgical gloves made of rubber and latex with a quota of 20% were introduced. The list of NCMI nomenclature for adhesive dressings has also been expanded, changed - for intraocular tonometers, medical refrigerators, consumables and components for mechanical ventilation, endoprostheses and external fixation devices^[3]

Ministry of Industry and Trade zeroes VAT for manufacturers of medical equipment

In mid-September 2023, it became known about the development in Russia of a new tool to support domestic manufacturers of medical devices. The initiative of the Ministry of Industry and Trade involves the introduction of a zero VAT rate for a part of Russian medical equipment. This will automatically eliminate essentially preferential treatment for imported products.

According to the explanations to the bill, manufacturers of medical goods "are not VAT payers," which is why they do not apply the deduction of the "input" value added tax. Meanwhile, they pay this tax by buying components. This leads to an increase in the cost of Russian medical equipment.

Russian manufacturers of medical devices will support the return of VAT

It is noteworthy that Russian manufacturers find themselves in unequal fiscal conditions, since for foreign products that are imported into Russia, the exporting country refunds them to VAT producers.

By mid-September 2023, Russian medical products and medical equipment are subject to preferential VAT in the amount of 10% or are not taxed. However, the same benefits apply to imported medical equipment - at the same time, a domestic manufacturer cannot deduct the "input" VAT included in the price of purchased products. And foreign producers, as a rule, receive compensation for this VAT in their country, RBC reports.

The Ministry of Industry and Trade notes that this creates inequality in fiscal conditions. The department proposes to withdraw some of the items from the list of goods exempted from VAT as sales in Russia. Thus, a three-element system of tax benefits will be formed, which will open the way for a domestic manufacturer.

In addition, the bill proposes to abolish preferential taxation for the import of foreign products. It is especially noted that such a step should not lead to an increase in the cost of imported medical devices.

The bill of the Ministry of Industry and Trade has been discussed since December 2022, by mid-September 2023 it was agreed, Ministry of Economic Development, and Ministry of Health. Roszdravnadzor FCS^[4]

The Ministry of Industry and Trade introduced a point system for assessing the localization of medical equipment

Prime Minister Mikhail Mishustin signed a decree approving the introduction of a point system for assessing the localization of 18 types of medical equipment. The corresponding document was published on August 10, 2023.

The list developed by the Ministry of Industry and Trade includes ultrasound devices, computed tomographs, mammographs, X-ray machines (mobile, complexes for two or three workplaces, on the basis of a remote-controlled tripod table), fluorographs, C-arcs, complexes for processing X-ray images, electrocardiographs, devices for functional diagnostic research and electrotherapy devices. In addition to them, surgical and laboratory sterilizers, devices for real-time PCR, installations for neutralizing medical waste, washing and disinfection machines, artificial lung ventilation devices, flat-panel digital X-ray detectors, operating lamps, microwave, high-frequency, low-frequency, ultrasonic therapy and magnetic therapy fell under the point system.

Points will be awarded for compliance with four procedures - the use of Russian raw materials, the use of domestic components, the implementation of technological operations during assembly and the volume of research work, which will be proportional to the volume of revenue. Mandatory requirements will also be introduced for the availability of technical documentation, R&D, a quality management system (QMS), the availability of production facilities and minimal technological operations - no points will be awarded for them.

The number of points required for the recognition of domestic products will increase from 2023 to 2025 and for a number of products will approach the bar of 100-120 points.

Government of the Russian Federation Resolution of August 8, 2023 No. 1293

Mishustin allocated 2 billion rubles for the development of components for medical equipment

Prime Minister Mikhail Mishustin signed a decree on the allocation of 2 billion rubles of projects to create components for enterprises operating in key industries. The main emphasis is on the production of solutions for medical devices, according to a document published on July 14, 2023.

The funds will be directed to 34 reverse engineering projects, providing for the development of design documentation for various components, including parts and components for medical equipment. Serial production of such components is planned to be established in the period from 2025 to 2030.

Prime Minister Mikhail Mishustin

The terms of grant support are determined by government decree No. 208 of February 18, 2022 and No. 522 of March 31, 2022. ANO Agency for Technological Development (Institute for the Development of the ВЭБ.РФ Group) was appointed the provider of the grant distribution.

The support measure is designed to localize the production of important products and increase the technological independence of Russia in critically needed components for key industries - oil and gas, energy, heavy engineering, machine tool, medical, chemical industries.

Russian manufacturers and legal entities will be able to apply for grants, the share of foreign ownership of which does not exceed 50%, without debts or unfulfilled penalties, which are not in the process of reorganization and liquidation. The maximum amount of the grant will not exceed 100 million rubles, it will be provided for a two-year period under a special agreement, under which up to 80% of the costs of paying for services for the development of design documentation can be compensated. Earlier, more than 3.9 billion rubles were allocated for the program.

Government of the Russian Federation Order of July 14, 2023 No. 1888-r

The Ministry of Industry and Trade gave preferences to Russian coronary stents on public procurement

On May 19, 2023, it became known that the Ministry of Industry and Trade of the Russian Federation amended Decree of the Government of the Russian Federation No. 617 of April 30, 2020 "On restrictions on the admission of certain types of industrial goods originating from foreign countries for the purpose of procurement to meet state and municipal needs." We are talking about giving preferences to Russian coronary stents and some other medical devices on public procurement. Read more here.

Mishustin approved the priority areas of Russia's technological sovereignty in the field of medical equipment. List

In April 2023, Prime Minister Mikhail Mishustin signed a decree approving priority areas for projects aimed at ensuring the technological sovereignty of Russia. The work will be carried out in 13 priority areas.

Prime Minister Mikhail Mishustin

In the medical industry, the priority is recognized:

• Manufacturing of parts and accessories for prostheses and orthopedic devices
• Production of hearing aids and their components
• Production of pacemakers and their components
• Manufacture of materials, dressings and similar products, including those covered with medicinal products
• Production of artificial joints, orthopedic devices, artificial teeth, dental equipment
• devices and other artificial parts of the human body, as well as their components, including bionic
• Manufacture of surgical and dental instruments and devices
• Production of devices based on the use of X-ray radiation used for medical purposes and their components
• Production of computed tomographs
• Fluoroscopic (flowroscopic) devices
• Radiographic devices
• Devices for use in dentistry based on the action of X-rays
• Other X-ray devices used for diagnostics, used for medical purposes
• Production of electrodiagnostic devices used for medical purposes and their components
• Electrodiagnostic devices
• Devices for functional diagnostic tests or control of physiological parameters used for medical purposes
• Electrodiagnostic devices for topical studies
• Parts and accessories of electrodiagnostic equipment and equipment based on the use of ultraviolet or infrared radiation intended for medical applications
• Production of artificial lung ventilation apparatus and its components
• Production of blood glucose control systems and their components
• Production of medical simulators
• Manufacturing of electronic components for medical devices
• Manufacturing of medical endoprostheses and implants
• Production of in vitro and in vivo diagnostic equipment

GOVERNMENT OF THE RUSSIAN FEDERATION RESOLUTION dated April 15, 2023 No. 603]

Deliveries of the first Russian composite materials for dental products began

Research Institute of Chemistry and Polymer Technology named after Academician V. A. Kargin began mass production and supply of the first Russian composite materials for dental products. This became known at the end of March 2023. Read more here.

2022

Ministry of Industry and Trade banned state purchases of foreign electric wheelchair seats

In November 2022, it became known about the decision of the Ministry of Industry and Trade of the Russian Federation to ban government purchases of electric wheelchair seats. The initiative is aimed at supporting domestic manufacturers on the eve of the implementation of a program to re-equip rehabilitation departments to "prevent the emergence of enterprises with a low level of localization" and "eliminate the dominance of foreign suppliers" (as stated in the department itself) in the market of rehabilitation medical products.

The document developed by the Ministry of Industry and Trade amends the Decree of the Government of the Russian Federation No. 616 of 30.04.2020. The document will contain the position "wheelchair wheelchairs, except for parts and accessories (in relation to electric wheelchair seats)," corresponding to the codes 207840, 207850, 207920, 208000, 208250, 208300, 208310, 208320, 208470, 208480, 208490, 208580. The decree will be applied according to the OKPD2 code and the name of the medical product. Also, electric wheelchairs will be excluded from the minimum quotas for the purchase of Russian products.

Ministry of Industry and Trade banned state purchases of electric wheelchair seats

Preferences under the "third extra" rule will be adjusted and will remain only for domestic mechanical wheelchair seats.

The Ministry of Industry and Trade estimates the annual demand for electric wheelchair for disabled people at 4 thousand units. At the same time, in 2021, according to the Social Insurance Fund, 2,078 electric wheelchair seats were purchased in Russia for a total of 312.3 million rubles.

The production capacity of Russian enterprises is estimated by the Ministry of Industry and Trade at more than 7.5 thousand medical products per year. The main domestic manufacturers of electric wheelchair seats are LLC Special Equipment Plant in Vladimir, LLC Podyem in Togliatti and Observer entrepreneur and inventor Roman Aranin.^[5]

The Ministry of Industry and Trade has established for medical institutions a minimum share of purchases of Russian electrocardiographs

In October 2022, the Ministry of Industry and Trade changed the list of medical devices for which the minimum share of public procurement is established. The innovation will enter into force on January 1, 2023 and concerns the supply of products in the same year.

The list of goods for which the minimum share of public procurement is introduced includes:

• Electrocardiographs;
• Photographic plates and photographic films are photosensitive, unexposed;
• Surgical rubber gloves;
• Surgical gloves made of rubber latex sterile disposable.

The Ministry of Industry and Trade has established for medical institutions a minimum share of purchases of Russian electrocardiographs

In this case, the following will be excluded from the list:

• Single-photon emission computed tomography (gamma camera) systems;
• Magnetic resonance tomographs;
• Operating and viewing medical lamps;
• Consumables for artificial lung ventilation devices;
• Consumables for donor plasmapheresis/thrombocytapheresis devices.

Also, the Ministry of Industry and Trade for some positions has reduced the minimum share of public procurement for 2023. We are talking about computer tomographs (from 75 to 30%), devices based on the use of alpha, beta or gamma radiation used for medical purposes, including surgery, dentistry, veterinary medicine, others (from 60 to 45%), and devices of optical and photographic equipment (from 90 to 70%).

In March 2022, the Ministry of Industry and Trade published a draft amendment to the Code of Administrative Offenses of the Russian Federation. The changes imply the introduction of sanctions for violation of the "national procurement regime," including when deviating from the annual minimum share of purchases of medical products from Russia and the EAEU countries. Officials, if the amendments are approved, face a fine of 5 to 55 thousand rubles, state customers - from 55 to 510 thousand rubles.

Previously, the minimum shares of the share of purchases of goods, including Russian medical products, were established in December 2020.^[6]

The Ministry of Health estimated at 31% the share of medical devices of domestic production in the Russian Federation

In July 2022, the Ministry of Health of the Russian Federation reported that domestic products account for almost a third of medical devices in the country.

We see that now more than 31% are domestic medical products in the Russian Federation, - said Elena Astapenko, director of the department for regulating the circulation of medicines and medical devices of the Ministry of Health, at a meeting at the House of Unions to discuss issues of the Russian market for the medical industry in the current economic situation.

The Ministry of Health estimated at 31% the share of medical devices of domestic production in the Russian Federation

According to her, by July 2022, more than one foreign manufacturer of medical products did not refuse supplies to the Russian Federation. There were logistical threats, but they are being worked out, Astapenko added.

In May 2022, the Ministry of Industry and Trade of the Russian Federation reported that the share of domestic medical equipment in Russia is planned to increase to 50% in two years and to 80% by 2030, state support will be provided to achieve the goal of the industry.

In addition, by May 2022, the possibility of state support for the industry was being worked out by stimulating the localization of medical products, as well as increasing the volume of their purchases for state needs. The improvement of the system for regulating the circulation of medical products, an increase in the reserves of the state reserve and the development of testing laboratories are being discussed. The Ministry of Industry and Trade also intends to work with the Ministry of Finance and the Ministry of Health to change tax regimes that will increase the competitiveness of Russian medical equipment.

According to Ivan Ozhgikhin, chairman of the Medical Technology Consortium, it is important to make the Russian medical equipment market more transparent for the end consumer. To do this, he proposed to create a marketplace for domestic medical equipment on the basis of the State Information System of Industry.^[7]

The Ministry of Industry and Trade returns to the point system for assessing the origin of medical equipment

As it became known at the end of June 2022, the Ministry of Industry and Trade returns to the point system for assessing the origin of medical equipment as part of the localization of production.

We are preparing to accept our long-suffering point system in computing in the near future. Following it, we will necessarily accept a point system in telecommunications equipment. Then the medical equipment will go, then everything else will go, - said the deputy head of the department Vasily Shpak.

The Ministry of Industry and Trade returns to the point system for assessing the origin of medical equipment

The development of a point system in Russia has been underway since 2021. The Ministry of Industry and Trade has developed a draft point system for determining the country of origin for another 22 types of medical devices, including vacuum tubes and bilateral needles for taking venous blood, coronary stents and catheters.

In June 2022, the Ministry of Industry and Trade announced its intention to include in the new procedure for determining the level of localization of an electrically powered wheelchair, as well as medical beds.

Amendments are proposed to be made to the Decree of the Government of the Russian Federation No. 719 of July 17, 2015. Manufacturers will be obliged to have their own scientific and technical divisions, the ad valorem share will be increased, and the depth of localization will be determined by the number of operations performed, the used domestic components and the number of operations during the assembly of medical equipment.

At the same time, the number of points required for confirmation will gradually grow until 2026.

In May 2022, the Ministry of Industry and Trade announced that domestic medical equipment should occupy half of the Russian market in two years.

Today, the task is to increase the share of domestic medical equipment on the market to 50% in two years and to 80% by 2030. To achieve these ambitious indicators, the Ministry of Industry and Trade of Russia is ready to support industry enterprises, the press service said.[8]

FMBA began work with Rosatom and Rostec on import substitution of medical devices

On May 25, 2022, it became known that FMBA began work with Rosatom and Rostec on import substitution. Read more here.

2021

The plan for the purchase of Russian ultrasound devices has been completed by 50%

The plan for the purchase of Russian ultrasound devices in 2021 was completed only by 50%. Anna Katamadze, deputy head of the Federal Treasury, spoke about this in April 2022. According to her, in 2021, state customers had to purchase at least 60% of ultrasonic scanning devices from Russian manufacturers, and in reality this share was 28%.

According to the procurement of upper limb prostheses, the quota was set at 45%, and only 9% was completed, for optical and photographic equipment, the quota was set at 50%, and 21% was completed. Among all the positions of Russian products planned for purchase in this format, in 2021, buyers managed to choose all quotas for 51 categories out of 99.

План по закупке российских аппаратов ULTRASONOGRAPHY only 50% completed in 2021

By April 2022 Russia , there are quotas for the purchase by state customers and state-owned companies of Russian-made goods or manufactured in countries. EEU The Government of the Russian Federation approved the lists of goods subject to quotas and the size of quotas for 2021-2023. The list includes various types of medical equipment and equipment, industrial products, light industry products, radio electronics.

According to the Ministry of Health, in 2020 - 2021, 31 regions did not fulfill the plan for the purchase of medical equipment for funds allocated from the federal budget. The agency explained the disruption of purchases by sanctions and restrictions amid the COVID-19 coronavirus pandemic and proposed not to apply financial liability measures for violation of obligations/

In March 2022, she presented a draft amendment to the Code of Administrative Offenses (CAO) of the Russian Federation, involving the introduction of fines for violating the "national procurement regime," including non-fulfillment of the annual minimum share of purchases of medical products from Russia and the EAEU countries.^[9]

Mishustin significantly reduced the limits of subsidies for the production of medical devices

At the end of December 2021, Prime Minister Mikhail Mishustin signed a decree of the Government of the Russian Federation, which significantly reduced the limits of subsidies for the production of domestic medical devices.

According to the new rules, manufacturers of Russian innovative medical products will be able to count on reimbursement at the expense of federal funds only 50% of the funds spent on their development instead of the previously established 70%.

Mikhail Mishustin significantly reduced the limits of subsidies for the production of medical devices

The subsidy is aimed at achieving the goals provided for by the federal project "Scientific Support for the Development of Medical Devices Production" of the state program of the Russian Federation "Scientific and Technological Development of the Russian Federation," and is provided in order to support Russian organizations - manufacturers of industrial products registered in the Russian Federation and carrying out activities to develop modern technologies, organize the production and sale of competitive medical devices on their basis, - said in a document published on the official Internet portal of legal information.

In addition to reducing the limits of subsidies for the production of domestic medical products, the procedure for forming and approving a list of strategic areas, that is, the names of specific types of medical devices for which state support will be provided, has changed. The powers to form it were shared by the Ministry of Health and the Ministry of Industry and Trade.

The Ministry of Health will determine the specific names and characteristics of medical products, and the Ministry of Industry and Trade, based on the proposals received from the Ministry of Health, will establish the maximum deadlines for the implementation of the project for the development and production of innovative medical equipment or consumables.

The decree entered into force on January 1, 2022.^[10]"

Mishustin approved the "second extra" rule for public procurement of MRT-, KT- and ultrasound scanners

In Russia, the "second extra" rule has been introduced for public procurement of 30 types of medical equipment. The corresponding government decree, signed by Prime Minister Mikhail Mishustin, was published on the official Internet portal of legal information at the end of August 2021.

The "second extra" rule implies that the customer is obliged to reject all applications for participation in the purchase, in which imported products are offered, if at least one application is submitted with a proposal to supply domestic medical equipment.

Mikhail Mishustin approved the "second extra" rule for public procurement of MRT-, KT- and ultrasound scanners

The "second extra" rule was introduced for computed tomographs, X-ray machines, endoscopic complexes, SPECT and gamma cameras. Gamma-therapeutic devices, electrocardiographs, pulse oximeters and spirometers, otorinoscopes, electroencephalographs, intraocular pressure tonometers, ultrasound devices, microwave and ultrasound therapy will also fall under it. In addition, restrictions will apply to magnetic resonance imaging, neonatal irradiators, lithotripters, defibrillators, medical refrigerators and freezers, air recirculator irradiators, sterilizers, electrosurgical devices, breathing equipment, incubators for newborns and medical gas supply consoles.

When purchasing imported products included in the new list, customers will have to obtain permission from the Ministry of Industry and Trade, justifying its need. Information on products should be contained in the unified register of Russian electronic products or in the register of Eurasian industrial products.

This act is a logical continuation of the principled policy of import substitution, which is maintained by the Ministry of Industry and Trade of Russia. The act was hard, met with great resistance on the way, but in the end we managed to do it, - comments on the innovation Deputy Minister of Industry and Trade of the Russian Federation Vasily Shpak. In the future, we will continue to create favorable conditions and opportunities for the development and strengthening of the position of Russian electronics manufacturers.[11]"

The Ministry of Industry and Trade introduces a point system for assessing the localization of medical equipment

In May 2021, it became known about the initiative of the Ministry of Industry and Trade to introduce a point system for assessing the country of origin of medical equipment. The department tightens the localization parameters.

As explained in the Ministry of Industry and Trade, the requirements for industrial products imposed to classify them as products produced in the Russian Federation are formed together with a wide range of manufacturers of relevant products, industry associations and specialized scientific organizations. These requirements regulate the production criteria with an indication of the number of points awarded for the implementation of technological operations, the use of Russian components and the implementation of R&D, which allows the manufacturer to build an individual localization schedule and encourages investment in the development of new technologies. The most points are awarded for localizing the most technologically advanced and expensive components.

The Ministry of Industry and Trade introduces a point system for assessing the localization of medical equipment

In the case of computed tomography machines, the scoring system will be as follows:

Use of Russian-made materials:

• nylon clamp ties (1 point);
• metal screws (1 point);
• fiber optic cable (1 point);
• high-voltage cables (1 point);
• service tools (3 points);
• metal washers (1 point);
• metal pins (1 point);
• fuses (1 point).
• patient table (20 points);
• PAC (image transmission and archiving systems) (15 points);
• automated workplace of a computer tomography doctor (20 points);
• electric power board (8 points);
• uninterruptible power supply (10 points);
• casings (10 points).

R&D:

The amount of research and development expenses implemented by Russian legal entities in the territory of the Russian Federation in the previous calendar year is 1 point for each 0.17 percent of the revenue for this product aimed at the implementation of research and development work (30 points).

Execution of technological operations in the Russian Federation:

• assembly of gentry (5 points);
• table assembly (4 points);
• operator console assembly (4 points);
• installation of computer tomograph system software (4 points);
• firmware of gentry and table controllers (3 points);
• setting of the detector unit (5 points);
• adjustment of the gantry rotation plane (3 points);
• alignment of the gantry scan center (3 points);
• calibration of the image acquisition system (5 points);
• electrical safety check (4 points);
• adjustment of mechanical characteristics of gentry (4 points);
• spatial resolution setting (3 points);
• Image uniformity setting (3 points).^[12]"

2020: The Government of the Russian Federation introduced the minimum shares of the purchase of domestic medical equipment

In early December 2020, the Government of the Russian Federation established a minimum share of purchases of goods of domestic origin, including medical equipment. The share is determined as a percentage of the volume of goods, works, services of the corresponding type carried out by the customer in the reporting year (from 2021 to 2023).

For example, the share of purchases of domestic artificial lung ventilation devices in 2021-2023. should grow from 50% to 70%, ultrasound devices - from 60% to 80%, X-ray diagnostics complexes - from 55% to 75%.

The Russian government introduced minimum shares of the purchase of domestic medical equipment for 2021

At least for the purchase of Russian defibrillators and heaters for children's neonatal, as well as for donor plasmapheresis/thrombocytopheresis and inhalation anesthesia, these figures are 50%, 60% and 70%. In incubators of intensive care for newborns, colposcopes for the next three years, the "Russian minimum" is 20%, 25% and 30%.

The minimum share is from electrical diagnostic and therapeutic equipment for radiation used for medical purposes: in 2021, 9% should be purchased from Russia, and in 2022 and 2023 - 10% each. The largest minimum shares for 2021 are set for medical freezers - 65%, steam sterilizers - 70% and medical gauze - 90% (the maximum indicator among medical devices).

The quota for endoscopic equipment is set at 55% in 2021 with an increase to 75% in 2023. In the case of SPECT and gamma-ray vehicles, the minimum share for 2021 is 40%, in 2023 it should be 60%.

Purchases started before January 1, 2021 are completed according to the previous rules. The decree of the Government of the Russian Federation will enter into force on January 1, 2021 and is subject to application to the procurement of goods, works, services carried out on January 1, 2021, the document says.^[13]"

2019: Russian ultrasound scanners and ventilators given preferences on public procurement

At the end of June 2019, Prime Minister Dmitry Medvedev signed a decree expanding the list of imported medical devices for which restrictions are established in public procurement.

Russian Prime Minister Dmitry Medvedev signed a decree that expanded the list of medical devices that state and municipal medical institutions should not purchase from foreign manufacturers

The updated list of products, when choosing which you need to give preference to goods of domestic production, is supplemented with 14 items. The list includes:

• ultrasound scanning equipment;
• endoprostheses of limb joints;
• medical beds;
• artificial lung ventilation devices;
• intraocular pressure measurement tonometers;
• devices, devices and complexes of contact radiation therapy;
• orthopedic children's shoes;
• breast ( mammary) exoprostheses ;
• inhalation anesthesia devices;
• medical bleached cotton gauze ";
• sterile and non-sterile gauze bandages;
• medical masks;
• sterile dressing bags and tampons
• anti-peduncle mattresses;
• sanitary and hygienic products - absorbent belle (diapers, diapers), but an exception has been made for diapers of size XS.

When at least two suppliers of these products originating from the EAEU countries enter the auction, applications of participants with foreign medical equipment will be automatically rejected. The press service of the government noted that "the decisions made are aimed at developing the production of medical devices in Russia."

The explanatory note to the government decree states that analogues of medical devices included in the list are produced in sufficient volume by at least two Russian companies in accordance with GOST ISO 13485-2011 "Medical products. Quality management systems. System requirements for regulatory purposes, "and the percentage of the value of foreign goods used in their production is no more than 50% of the price of the final product^[14]

2017: Russian doctors did not allow Minek to import substitution of coronary stents and catheters

On February 17, 2017, the Government of the Russian Federation discussed with representatives of the medical community the initiative proposed by the Ministry of Economic Development to include coronary stents and catheters of foreign production in the list of medical devices subject to restrictions in public procurement in the event of domestic analogues. Russian doctors called the localization of production a solution to the problem of import substitution of medical products.

The Ministry of Economic Development proposed amendments to government decree No. 102 "On restrictions and conditions for the admission of certain types of medical devices originating from foreign countries for the purpose of making purchases to meet state and municipal needs."

Coronary stent

Doctors abandoned this idea, considering it outdated and capable of depriving patients of vital consumables, including high-quality and safe stents, implants and catheters, the effectiveness of which has been proven by international clinical research and experience in application at the global level.

Irina Chazova, chief freelance cardiologist of the Russian Ministry of Health, said that domestic medical products do not have a convincing evidence base on the effectiveness and safety of use, collected as a result of many years of clinical studies.

In Western countries, conducting clinical trials and providing their results is a prerequisite for the stent to enter the medical device market and an integral part of the quality control of stents, Chazova said.

According to experts from the medical community, one of the options for solving the problem of import substitution of medical devices is the localization in Russia of the production of high-tech products recognized worldwide. But so far there are few such examples. By February 2017, Stentex is carrying out measures to transfer the production of Medtronic technologies to Russia.^[15]

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