Directions for improving the institutional system of regulation of the medical device market

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Abstract

Background. The contemporary system governing the circulation of medical devices operates under conditions that combine stringent requirements for product quality and safety with the necessity to ensure the stable functioning of a strategically significant sector. The specific features of this segment are determined not only by economic but also by institutional factors that define the framework and logic of stakeholder interaction. This study is devoted to a comprehensive analysis of the institutional system of state regulation in the medical device market, applying the methodological principles of institutional theory, which emphasizes the role of formal norms, procedures, and enforcement mechanisms. Current approaches to managing this sector in the Russian Federation and in foreign jurisdictions are examined, and key institutional barriers that reduce investment and innovation activity are identified. The research substantiates the need for establishing a coherent and sustainable institutional system capable of minimizing transaction costs, enhancing the transparency of regulatory procedures, and stimulating the diversification of production capacities.

Purpose. To develop scientifically grounded proposals for improving the institutional system of state regulation in the strategic segment of the medical device market.

Methodology. The study employs institutional analysis, comparative legal analysis, systematization of legal acts, and a structural-functional approach.

Results. Key institutional shortcomings in the current regulatory system are identified, along with concrete mechanisms for addressing them.

Practical implications. The results can be used in the development of public policy in the healthcare sector, improvement of legal frameworks, and advancement of the institutional environment governing the medical device market.

About the authors

Alexey Yu. Shtanko

Ural Federal University named after the first President of Russia B.N. Yeltsin

Author for correspondence.
Email: ssshtanko@gmail.com
ORCID iD: 0009-0005-7746-0624

Post-Graduate Student of the Department of Regional Economics, Innovative Entrepreneurship and Security

 

Russian Federation, 19, Mira Str., 19, Yekaterinburg, Sverdlovsk region, 620002, Russian Federation

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