Review of the world's medical device registration systems
https://doi.org/10.25881/18110193_2025_2_6
Abstract
All medical devices, both in the Russian Federation and in the world, undergo registration procedures. However, the related rules and legislation are regulated differently.
The purpose of this study was to assess the functionality of the existing legal framework and registration systems for medical devices in some countries of the world.
Keywords
Supporting agencies: This article was prepared by the author's team within the framework of the research "Scientific methodologies for the sustainable development of artificial intelligence technologies in medical diagnostics", (EGISU No.: No. 123031500004-5) in accordance with Order No. 1258 dated 12/22/2023 "On approval of state assignments, the financial support of which is provided from the budget of the City of Moscow to state budgetary (autonomous) institutions subordinate to the Department of Health of the city Moscow, for 2024 and the planned period of 2025 and 2026" Department of Health of the City of Moscow
About the Authors
N. V. Tarasova
State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department"
Russian Federation
Russian Federation
Natalia Vladimirovna Tarasova, PhD
Moscow
A. V. Vladzymyrskyy
State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department"
Russian Federation
Russian Federation
DSc
Moscow
E. A. Petrov
State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department"
Russian Federation
Russian Federation
PhD
Moscow
S. Y. Zayunchkovsky
State Budget-Funded Health Care Institution of the City of Moscow "Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department"
Russian Federation
Russian Federation
Moscow
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Review
For citations:
Tarasova N.V., Vladzymyrskyy A.V., Petrov E.A., Zayunchkovsky S.Y. Review of the world's medical device registration systems. Medical Doctor and Information Technologies. 2025;(2):6-15. (In Russ.) https://doi.org/10.25881/18110193_2025_2_6
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