Abstract
<jats:p>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 The problem lies in institutional fragmentation, inconsistency of powers and outdated regulatory mechanisms, which hinders the implementation of innovations and reduces the competitiveness of domestic manufacturers.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.</jats:p>