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Shtanko A.Yu., Panikarova S.V.
APPROACHES TO STATE REGULATION OF THE MEDICAL DEVICES MARKET IN RUSSIA AND ABROAD
Keywords: medical devices, healthcare market, medical devices market, state regulation
Regulation of the medical devices market is one of the key tasks of the state policy, as this sector has a direct impact on public health and national security. In the context of increasing competition and rapid progress in medical technologies, the need for enhanced control and support of this sector is becoming increasingly relevant. The study of the regulation of medical devices is of both theoretical and practical interest, as it contributes to improving product quality and increasing its competitiveness in the global market. The purpose of the study is to conduct a comparative analysis of different approaches to the state regulation of the medical devices market and assessment of their impact on the development and structural changes within this market. Materials and methods. The primary sources of information were official documents, scientific articles, and reports from international organizations. The research applied the methods of system analysis and comparative approach. During the study, evaluation of the legislative acts and programs aimed at regulating the medical devices market in Russia, the USA, and the EU countries was conducted. Results. This study characterizes the features of the medical devices market and its state regulation, providing an analysis of regulatory policies for the medical devices market in Russia and abroad, which reveals key differences in approaches. It has been established that in Russia, the regulatory model is closely linked to state programs aimed at supporting domestic production, including an import substitution policy. In contrast, international approaches focus on promoting innovation and simplifying certification procedures, facilitating faster introduction of new products to the market. Conclusions. A comparative analysis of existing regulatory models showed that in Russia, the primary focus is on import substitution and subsidies. In other countries, the emphasis is shifted to supporting innovation and accelerating the certification process. The implementation of certain elements of foreign models into the Russian regulatory system could enhance its flexibility and promote the active development of innovations, which, in turn, would improve the competitiveness of domestic medical devices manufacturers.
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About authors
- Shtanko Alexey Yu.
- Post-Graduate Student, Department of Regional Economics, Innovative Entrepreneurship and Security, Ural Federal University named after the first President of Russia B.N. Yeltsin, Russia, Ekaterinburg (ssshtanko@gmail.com; ORCID: https://orcid.org/0009-0005-7746-0624)
- Panikarova Svetlana V.
- Doctor of Economics Sciences, Professor, Department of Regional Economics, Innovative Entrepreneurship and Security, Ural Federal University named after the first President of Russia B.N. Yeltsin, Russia, Ekaterinburg (S.V.Panikarova@urfu.ru; )
Article link
Shtanko A.Yu., Panikarova S.V. Approaches to state regulation of the medical devices market in Russia and abroad [Electronic resource] // Oeconomia et Jus. – 2025. – №1. P. 65-78. – URL: https://oecomia-et-jus.ru/en/single/2025/1/6/. DOI: 10.47026/2499-9636-2025-1-65-78.
