Formation of the market of software medical devices in the Russian Federation in 2007–2024: Practical results

According to the recommendations of The International Medical Device Regulators Forum (IMDRF), software intended for medical purposes falls under the category of medical devices (MD). In recent years, in Russia, a great deal of systematic work has been carried out to establish normative regulations and processes for controlling the efficiency and safety ofsoftware as medical devices (SaMD) and its subsequent state registration. Objective. The analysis of current procedures and results of state registration of SaMD in the Russian Federation in 2007–2024. Materials and methods. A systematic search of information on the software registered in Russia as MD was carried out. For this, the state registry of MD of the Federal Service for Surveillance in Healthcare of Russia (Roszdravnadzor) was used. 157 records of marketing authorizations (MA) issued between 01. 01. 2007 and 30. 07. 2024 were found. Results. 25.5 % of MAs were issued for radiological information systems, including image archiving and communication systems (PACS-systems). For SaMD with artificial intelligence technologies – 24.2 % MAs. 13.4 % of MAs were issued for laboratory information systems and 4.5 % for medical information systems of medical organizations. The “Other software” group accounted for 32.5 %, it included telemedicine solutions, software for planning surgeries, etc. More than 50 % of Mas for SaMD was issued for Russian-based developers. Half of SaMD was registered as the 2nd class of potential risk application (50 %), 17 % as the class 2b, and 18 % as the lowest 1 st class of potential risk. 15 % of SaMD were of the maximum 3 rd class of the potential risk of application, and most of them were SaMD with artificial intelligence (AI) technologies. Conclusion. In Russia, a system of independent testing and state registration of SaMD has been built and has been working reliably for many years, allowing manufacturers to bring to the market the most diverse products, including innovative AI-based MD. Russian development companies are gradually increasing their market share compared to foreign producers.