STATE REGULATION OF THE RUSSIAN MEDICAL DEVICES MARKET
Abstract
The study examines state regulation of the medical devices market in the Russian Federation, which is highly dependent on imports and has insufficient transparency of certification and standardization procedures. The problem lies in institutional fragmentation, inconsistency of powers and outdated regulatory mechanisms, which hinders the implementation of innovations and reduces the competitiveness of domestic manufacturers. The purpose of the work is to develop a set of solutions to improve the state regulation of the medical device market in the Russian Federation. To achieve this goal, statistical, economic and balance methods were used, as well as content analysis of documents to identify emerging contradictions in regulatory legal acts and dysfunctions of government bodies regulating the market. The results of the study show that the key barriers to market development are excessive administrative procedures, imperfect standards and the dominance of the price criterion in public procurement. The following institutional transformations are proposed: adoption of a unified federal law «On Medical Devices», the tasks and functions expansion for the Department for Regulation of the Circulation of Medicines and Medical Devices of the Health Ministry of the Russian Federation, implementation of a digital «single window», transition to risk-oriented supervision and a multi-factor procurement system. The scientific novelty of the study lies in the development of a comprehensive regulatory model that takes into account institutional, legal and economic aspects. The practical significance comes from the possibility of applying the proposed solutions in the implementation of national import substitution and digitalization strategies.
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References
Akerlof, G.A. (1970) ‘The market for “lemons”: Quality uncertainty and the market mechanism’, Quarterly Journal of Economics, 84(3), pp. 488–500.
Barkovskaya, E.V., Shalenkova, E.V., Ponomareva, A.A., and Mishchenko, E.S. (2021) ‘Modern aspects of regulatory regulation of the circulation of medical devices’, Eurasian Scientific Association, 12-2(82), pp. 183–186.
Bayrak, A.O. (2025) ‘Assessment of the impact of external factors on the development of the private medical sector in the Russian Federation’, Innovations and Investments, (3), pp. 346–349.
Belousov, P.E. and Kiseleva, V.A., et al. (2022) ‘Medical products on the local pharmaceutical market’, in Medicine and Pharmacy: Past, Present, Future. Proceedings of the III All-Russian Scientific and Practical Conference with International Participation, Orekhovo-Zuyevo, pp. 24–26.
Bondarchuk, A.V., Vasiliev, P.A., and Kramarenko, S.A. (2025) ‘Institutional mechanisms for reforming the development of the Russian domestic market’, Economics and Entrepreneurship, 3(176), pp. 510–516.
Buchanan, J.M. (1987) The limits of liberty: Between anarchy and Leviathan. Chicago: University of Chicago Press.
Buchanan, J.M., and Tullock, G. (1962) The calculus of consent: Logical foundations of constitutional democracy. Ann Arbor: University of Michigan Press.
Burke, H. (2024) ‘Who are the top 10 medical device companies in the world in 2024?’, Proclinical, 25 October. Available at: https://www.proclinical.com/blogs/2024-10/top-10-medical-device-companies-in-the-world-in-2024 (accessed 31 October 2025).
Coase, R.H. (1937) ‘The nature of the firm’, Economica, 4(16), pp. 386–405.
Chettri, B., and Ravi, R. (2024) ‘A comparative study of medical device regulation between countries based on their economies’, Expert Review of Medical Devices, 21(6), pp. 467–478. DOI:10.1080/17434440.2024.2360979
Cherkasov, D.I. (2023) ‘Transformation of modern business in the field of healthcare: Opportunities and potential of manufacturers of medical products from China and South Korea’, in Theory and Practice of Management: Responses to the Challenges of the Digital Economy. Proceedings of the XIV International Scientific and Practical Conference of Students and Postgraduates, Moscow, pp. 220–222.
Cherezova, Ya.A., and Makarova, V.A. (2024) ‘Promotion of new brands of medical products on the Russian market’, in Cooperation of Science and Society – the Path of Innovative Development. Proceedings of the All-Russian Scientific and Practical Conference, Saratov, pp. 115–117.
Dyatlova, M.I. (2018) ‘Prospects and trends of the world market of medical products, the level of competitiveness of Russian-made medical products’, Bulletin of the RUDN University. Series: Economics, 26(2), p. 297.
Geleta, T.V., and Nash, R.A. (2025) ‘State regulation of the economy in the context of sanctions pressure’, Applied Economic Research, (3), pp. 103–110.
Jefferys, D.B. (2001) ‘The regulation of medical devices and the role of the Medical Devices Agency’, British Journal of Clinical Pharmacology, 52(3), pp. 229–235. DOI:10.1046/j.0306-5251.2001.01416.x
Khorunzhaya, A.A., and Puhakainena, Yu.A. (2022) ‘The market of medical devices: Fundamental features’, in Young Pharmacy – the Potential of the Future. Proceedings of the XII All-Russian Scientific Conference of Students and Postgraduates with International Participation, St. Petersburg, pp. 1244–1248.
Medical equipment and products market 2023: An analytical review (2023). Available at: https://delprof.ru/press-center/open-analytics/rynok-meditsinskogo-oborudovaniya-i-izdeliy-2023 (accessed 31 October 2025).
Munassar, M.A., and Sosnilo, A.I. (2022) ‘Trends and prospects of the global market of medical instruments for laboratory diagnostics’, Scientific Journal of the National Research University of ITMO. Series: Economics and Environmental Management, (2), p. 103.
Parvizi, N., and Woods, K. (2014) ‘Regulation of medicines and medical devices: Contrasts and similarities’, Clinical Medicine, 14(1), pp. 6–12. DOI:10.7861/clinmedicine.146
Nesterenko, Yu.Y., and Kirilchuk, S.P. (2024) ‘Institutional environment and institutionalization of behavioral regulation: Theoretical foundations of economic development’, Theoretical Economics, 4(112), pp. 107–118.
Nureyev, R.M., Latov, Yu.V., Orekhovsky, P.A., et al. (2024) Ronald Coase and the new institutional theory. Moscow: KnoRus.
Paschenko, A.D., and Paschenko, T.Y. (2020) ‘Analysis of the Russian market of medical devices from the point of view of ensuring national security’, in Conference Proceedings of SIC Sociosphere, (25), pp. 338–342.
Polterovich, V.M. (2006) ‘Strategies of institutional reforms: Promising trajectories’, Economics and Mathematical Methods, 42(1), pp. 3–18.
Popov, A.A., Sherstneva, E.P., Karashchuk, E.V., and Kalinin, A.V. (2024) ‘Market analysis of disposable medical devices: Features and prospects of market development’, in Innovative Potential of Science Development in the Modern World: Technologies, Innovations, Achievements. Proceedings of the XV International Scientific and Practical Conference, Ufa, pp. 414–422.
Samoilova, A.V., Pavlyukov, D.Y., and Ivanov, I.V. (2023) ‘Circulation of medical devices: Modern challenges’, Bulletin of Roszdravnadzor, (5), pp. 11–18.
Shi, L. (2024) ‘A review on the evolving environment of medical device real-world evidence regulation on market access in the USA’, Cost Effectiveness and Resource Allocation. DOI:10.1186/s12962-024-00582-9
Stiglitz, J.E. (2002) ‘Information and the change in the paradigm in economics’, American Economic Review, 92(3), pp. 460–501.
Stolyarov, S.A. (2005) The medical services market: Some of its characteristics, problems and aspects of management. 3rd edn. Barnaul: Az Buka.
Telnova, E.A., and Proklova, T.N. (2019) ‘Foreign experience in the functioning of the control system for the circulation of medicines’, Bulletin of the National Research Institute of Public Health named after N.A. Semashko, (2), pp. 112–131.
Verzilin, D.N., and Kustov, O.M. (2016) ‘Interdependence of public health and economic security in the healthcare system’, in Aleksanin, S.S. (ed.) Multidisciplinary Clinic of the XXI Century: Advanced Medical Technologies. Materials of the International Scientific and Practical Congress, St. Petersburg: Man, pp. 47–48.
Vokina, S.G. (2021) Economics of medicine: Medical services, innovations, pricing, management. Moscow and Vologda: Infra-Engineering.
Vylgina, Yu.V., and Bandyuk, A.I. (2024) ‘Research of the structure of the medical equipment market in the Russian Federation for the formation of the concept of commercialization of innovations’, Applied Economic Research, (4), pp. 175–183.
Zuenkova, Yu.A. (2024a) ‘Analysis of the Russian market of ventilators’, Management Sciences, 14(2), pp. 127–142.
Zuenkova, Yu.A. (2024b) ‘The impact of sanctions on the structure of foreign trade in medical products (using the example of consumables)’, National Interests: Priorities and Security, 20(11), pp. 2020–2034.
Zuenkova, Yu.A. (2024c) ‘Choosing a competitive strategy for launching a medical device on the market: Using the example of technical rehabilitation tools’, Economic Strategies, 26(4), pp. 136–143.
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