Background. Research on the development and implementation of new principles and methods applicable in the evaluation of medical devices (MD) will allow to accumulate new, as well as the most effective long-used and proven approaches to the clinical and economic evaluation of such an important and extensive class of medical technologies.Aims. The aim of the study is to identify and analyze developed, approved recommendations for the assessment of MD in the world and domestic practice of assessing health technologies, as well as to find and summarize the current principles, optimal proven and innovative methods for assessing MD for the draft modern recommendations for MD assessment in Moscow.Materials and methods. The sources of the study were scientific articles on the topic of MD assessment and recommendations published over the past five years.Results. A review of publications revealed disunity in the approaches to assessing MD according to international sources, as well as the lack of unified agreed recommendations in Russia. A number of problems and aspects that need to be taken into account when formulating uniform recommendations are clearly defined.Conclusion. It is obvious that there is a need to formulate and adopt clear recommendations on the assessment of medical technologies (HTA) of MD, taking into account positive international experience.

Purpose. To evaluate clinical trials data since January 2021 till March 2021. Materials and methods. The information about clinical trial’s approvals from the state register of medicines of Russian Federation ministry of health website was used as the main source of the original data concerning clinical trials. The register contains all the information relating to clinical trials in Russian Federation. Results. Clinical trials data was analyzed by its type (international, local, bioequivalence), sponsorship (foreign, local), phases and disease areas. Separately COVID-19 clinical trials were considered. Conclusion. During the 2021 Q1 we can mark a clinical trail’s quantity growth (started ones) both in Russia and in Moscow in comparison with 2018-2020 similar periods, that is definitely a positive trend especially in COVID-19 pandemic circumstances. There is a significant growth of bioequivalence share in 2021 versus 2019-2020 in Moscow. Due to SARS-CoV-2 ongoing pandemic lots of related to SARS-СоV-2 treatment clinical trials started, which considerably increased the contagious diseases pool in clinical trials market structure. Totally 14 related to SARS-СоV-2 treatment trials started in Russia, including 5 ones held in Moscow Healthcare Department medical organizations.