Introduction. In recent years, scientific research has focused on new approaches and methods used by Roszdravnadzor, including the use of modern monitoring and control and surveillance means. To date, significant changes have taken place in the healthcare system of the Russian Federation. The reforms have affected all major areas of medical activity, including increased control over the turnover of medicines and medical equipment. And the use of a risk-based approach in control and supervisory activities makes it possible to reduce the number of State inspections. Purpose of the investigation. Analysis of the effectiveness of the risk-based approach in the field of healthcare, its implementation and application in the practice of the Regional Office of Roszdravnadzor in the Ryazan region. Materials and methods. The study was conducted from 2016 to 2023 on the territory of a constituent entity of the Russian Federation. Empirical (content analysis and comparison) and theoretical (abstraction, analysis, synthesis, mental modeling) research methods, descriptive statistics methods are applied. The evaluation of the parameters of the trend equation included calculating the relative approximation error, measuring the tightness of the dependence of the dynamics indicator on time, the approximation coefficient and the Fisher criterion. Results and discussion. The analysis of regulatory legal acts has shown that in the context of the modern development of the healthcare system, which is characterized by an increasing importance of the level of risks, it is important to find effective ways to control and manage them. In this context, a risk-based approach to control is seen as an important tool for improving patient safety and ensuring the quality of medical care. The vast majority of controlled subjects engaged in medical activities and subjects of medical device circulation in the Ryazan Region belong to the low-risk category (90,43% and 95,1%, respectively). The structure of the total number of controlled subjects engaged in activities in the field of drug circulation differs by risk categories from the two control objects presented above: high risk is established for 72,8%, and low – only for 16,8%. In 2016-2023, there was a 14-fold decrease in the number of inspections conducted compared to 2016, against a 5,6-fold increase. With fewer inspections, the detection rate of violations in the healthcare system increases: from 24,9% in 2016 to 66,7% in 2023. The trend assessment showed a statistically significant pronounced steady trend towards an increase in the proportion of detected violations (R2=0,7047; F=14,32; Fcritical data=5,99; p