Subject. This article discusses the expansion of the range of medical devices manufactured in Russia and import substitution in the healthcare sector. Objectives. The article aims to determine the subjects and objects of the market of medical devices and analyze the regulatory legal acts governing the circulation of medical devices in Russia. Methods. For the study, we used statistical and content analyses. Results. The article finds that the concepts of medical market, market of medical services, and market of medical devices are not clearly defined in Russian legislation, and many State and interstate standards for medical devices need to be updated. Conclusions. It is necessary to draft and adopt a Federal law On the Production and Circulation of Medical Devices in the Russian Federation, which, in particular, will regulate the issues of import substitution in the healthcare sector.