According to the results of last year, the Scientific and Technical Center "MEDITEX" prepared a detailed overview of the development of the Russian market of medical devices and technologies. In agreement with the authors, we publish the review with some abbreviations.
Medical device manufacturing (MI) is a critical and rapidly growing segment of the healthcare industry. Manufacturers of medical devices produce a wide range of products - from sophisticated diagnostic and therapeutic equipment to simple medical instruments and consumables that are used in medical institutions, emergency services, rehabilitation of disabled people and at home.
In recent years, many manufacturing companies in the industry have made significant technological advances and have grown exponentially. Despite tight regulation and financial pressure on the industry, the market continues to grow globally.
Currently, the global market for medical devices is estimated at more than 425 billion USD and, according to industry experts, will reach 612.7 billion USD by 2025.
The Russian market for medical devices occupies about 1.5% of the world market. The volume of the MI market in 2019 in the Russian Federation amounted to more than 304.9 billion rubles, which is 6% more than in the previous year.
According to experts' forecasts, by the end of 2024, the volume of the medical device market may reach 450 billion rubles. The share of Russian manufacturers is expected to grow to 32%. Taking into account support measures, the share of Russian manufacturers for the period up to 2024 will increase from 23 to 32%.
This market growth will be driven by regulatory changes in 2019.
Significant changes in the regulatory field last year:
1. In June 2019, the Prime Minister of the Russian Federation Dmitry Medvedev signed a list of medical devices extended by 14 positions that fall under the Decree of the Government of the Russian Federation No. 102 of February 5, 2015. At the moment, the list already includes 174 types of goods, including absorbent underwear (diapers and diapers), parts and accessories of prostheses, orthopedic appliances, products for prosthetic and orthopedic products, insoles, bandages, splints and much more.
2. The Ministry of Industry and Trade of the Russian Federation has developed new mechanisms of state support for the medical and pharmaceutical industry, providing for:
2.1. financial support for the costs of manufacturers for the implementation of projects, from the R&D stage and clinical trials / trials to the implementation of the development in industrial production;
2.2. determination of the recipients of subsidies within the framework of competitive procedures;
2.3. the widest possible list of subsidized costs;
2.4. setting the indicator of proceeds from the sale of products created within the framework of the project as the main indicator of the effectiveness of project implementation;
2.5. determination of the recipients of subsidies within the framework of competitive procedures carried out within the framework of each technology from the modern technologies included in the list, approved by the government of the Russian Federation.
The list of strategic directions for the development of the medical industry includes the development and organization of production of medical devices in the field of orthopedics, traumatology and prosthetics, test systems for in vitro diagnostics, detection of oncological diseases and pathologies of the cardiovascular system.
In early August 2019, the President of the Russian Federation signed a law on amending the Federal Law of December 31, 2014 No. 488 "On industrial policy in the Russian Federation" in terms of regulation of special investment contracts. And also in the Budget and Tax Codes.
Now special investment contracts (SPIC) can be concluded for the development and organization of production of "modern technologies". At the same time, the SPIC will be concluded for no more than 15 years for projects for which the volume of investments does not exceed 50 billion rubles excluding VAT, and for no more than 20 years with investments exceeding 50 billion rubles. In the previous version, the maximum contract duration was ten years.
One of the key events of 2019 was the development of a list of medical equipment for the re-equipment of clinics under the Healthcare national project.
The list for re-equipping clinics under the oncology program of the national project included 147 units of medical devices, including CT, MRI, PET, angiographs, brachytherapy machines, various X-ray equipment and several types of ultrasound scanners.
The list also includes a line for clinical and laboratory diagnostics, which includes several types of analyzers.
It should be reminded that healthcare institutions are recommended to purchase medical products and equipment from domestic manufacturers with “equivalent technological characteristics”.
For this, the Russian Ministry of Industry and Trade, together with the State Atomic Energy Corporation Rosatom, Rostec and other Russian manufacturers, compiled a consolidated list of products.
The RF Ministry of Industry and Trade expects that the implementation of the national project will increase the share of Russian manufacturers to 40%.
Throughout the year, there was an active discussion of the possibility of extending the transition period for re-registration of medical devices that have a registration certificate in their country, according to the rules of the EAEU.
And finally, on September 9, the EEC Board issued Order No. 142 "On the Draft Protocol on Amendments to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the Eurasian Economic Union dated December 23, 2014".
In November 2017, the EEC Council approved the Requirements for the implementation, maintenance and assessment of a quality management system for medical devices, depending on the potential risk of their use. The document provides for a mandatory inspection of medical device production, the use of which is associated with a high risk to the well-being of the patient.
On March 16, 2019, the transitional period ended, which provided manufacturers with a grace period from conducting inspections.
Inspection is provided as part of the registration of MI, as well as planned and unscheduled. An unscheduled inspection is possible in the event of undesirable events associated with the threat of harm to the health and life of citizens. Scheduled inspections will be carried out at regular intervals. It should be understood that in the event of a negative decision based on the results of an unscheduled and periodic inspection, there may be a question of suspending or terminating the production and circulation of a medical device. Depending on the identified problems, it will be possible to eliminate inconsistencies and conduct additional inspections, already in a smaller volume.
On June 10, at the EEC headquarters, a meeting of the working group on the assessment of the regulatory impact of the draft decisions of the EEC was held, implying an assessment of their impact on the conditions for doing business in the Union.
At the meeting, it was proposed to provide an integrated approach to the regulation of the activities of organizations entitled to inspect the production of medical devices.
Also, according to the members of the working group, it is necessary to provide for uniform requirements for such organizations and unified procedures for empowering them with inspection powers in one document.
In Russia, the inspection of production facilities is entrusted to Roszdravnadzor.
Roszdravnadzor will evaluate the design and development of a medical device, document and record management, manufacturing and final inspection, and consumer-related corrective and preventive action processes. Separately, you will have to pay for the selection and testing of samples of implantable, invasive medical devices, as well as devices for in vitro diagnostics of the third risk class.
Work has begun to improve the registration procedure for medical software (software).
The Association of Developers and Users of Artificial Intelligence Systems in Medicine "National Base of Medical Knowledge" (NBMZ) and the Skolkovo Foundation propose to simplify the state registration of medical software without registering it as a medical device. For this, a draft Federal Law was developed on amending the federal law "On the basis of public health protection." He proposes the introduction of the concept of medical software (MPS), a special procedure for its state registration and the ability not to subject it to some types of software included in MPS and the software that is not.
The RF Ministry of Health does not support the bill. Roszdravnadzor still believes that the problem of registering medical software must be solved without changing the law, according to which this software is now registered as a medical device - at the level of bylaws.
In October, at a sectoral working meeting of Roszdravnadzor, it was decided to create working groups to resolve issues related to the registration of medical software.
Localized production
An important result of 2019 can be considered the start of sales of localized products at several enterprises. In addition, new agreements on strategic partnership were signed between Russian and foreign companies.
Fetal monitors FC 1400 manufactured at the Ural Optical and Mechanical Plant named after E.S. Yalamov (UOMZ) are on sale. The production of new equipment was established in cooperation with a South Korean company. UOMZ is part of the Shvabe holding of Rostec State Corporation.
In the fall of 2019, a long-term partnership agreement was signed by another enterprise of the Shvabe holding. We are talking about an agreement between the Krasnogorsk plant. S. A. Zvereva and the leading European manufacturer of endoprostheses "Lima corporate".
At the start of the project Krasnogorsk plant named after S. A. Zvereva will act as a distributor of products and begin a phased transition to the localization of technologies at his production site.
Gradually, the level of localization will be increased to 51%, and then it is planned to organize a full-cycle production in Russia.
In addition, a plant for the production of implants for traumatology and orthopedics is going to be built in the Yurga PSEDA by the company Double Medical.ru2, using the technology of the Chinese company Double Medical.
The plant will produce plates for extramedullary osteosynthesis, screws, pins for intramedullary osteosynthesis and systems for transpedicular fixation of the spine from titanium and its alloys.
The investor has already signed an agreement with one of the largest Russian distributors, the Health group, which will sell products not only in Kuzbass, but also in other regions of Russia. The authors of the project predict the growth of the Russian implant market from the current 6 to 9 billion rubles. by 2021.
The French-Israeli company Luneau Technology Operations (LTO), together with TechnoSparka LLC, Rusnano Group of Companies, localized the production of medical ophthalmological equipment in Russia.
The decision to launch an equipment localization project in Russia was made in mid-2017. And in September 2019, the Russian division of Visionix Rus received the long-awaited registration certificate for a Visionix diagnostic device.
Thus, at present, the Government of the Russian Federation is adopting measures and laws aimed at protecting, supporting and developing domestic production, which at the same time do not limit the possibilities of technology transfer, stimulate the localization of foreign production and the development of projects with the attraction of foreign investment. This, in turn, enables experts to predict an increase in the growth rate of the medical device market in Russia.
Author of the material: Scientific and Technical Center "MEDITEX".
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