Problems of Social Hygiene, Public Health and History of MedicineProblems of Social Hygiene, Public Health and History of Medicine0869-866X2412-2106Joint-Stock Company Chicot153810.32687/0869-866X-2024-32-5-918-923НеопределенThe actual issues of mandatory labeling of certain types of medical itemsTonkonogV Vvikatonkonog79@mail.ruThe Federal State Budget Educational Institution of Higher Education “The Admiral F. F. Ushakov State Maritime University”, 353924, Novorossiysk, Russia271020243252604202526042025Copyright © 2025,2025<p>Mandatory labeling of medical items plays key role in establishing uniform standards and requirements for all market participants. This promotes increasing of protection of consumer rights, excluding possibility of buying unreliable or counterfeit products. The normative documents regulating labeling of medical items set important requirements to manufacturers, importers and retailers. The unique identifiers, information about origin and other data provided for inclusion in labeling ensure product identification and control of its quality. The article considers normative legal base regulating procedure of mandatory labeling of certain types of medical items from their production and putting into use up to moment of their sale and withdrawal from market turnover. Besides, mechanism of state regulation of procedure of labeling of medical items targeted to increasing of traceability of products, reducing spread of counterfeit goods, ensuring patient safety and improving quality of medical services in general is considered.</p>medical itemslabelingidentification toolsmonitoring systemstate regulationturnover of medical itemsмедицинские изделиямаркировкасредства идентификациисистема мониторингагосударственное регулированиеоборот медицинских изделий1.Decree of the Government of the Russian Federation dated May 31, 2023 No. 894 “On approval of the Rules for labeling certain types of medical devices by means of identification and the specifics of implementing the state information system for monitoring the turnover of goods subject to mandatory labeling by means of identification relation to certain types of medical devices”. Garant. Available at: https://www.garant.ru/products/ipo/prime/doc/406872710/ (accessed 04.03.2024) (in Russian).2.Decision of the Board of the Eurasian Economic Commission No. 100 dated July 13, 2022 “On technological documents regulating information interaction in the implementation of the common process by means of the integrated information System of the Eurasian Economic Union “Ensuring the exchange of information on goods subject to labeling by means of identification produced or imported into the customs territory of the Eurasian Economic Union, including in cross-border turnover of such goods in the customs territory of the Eurasian Economic Union” in terms of the exchange of information on goods subject to labeling by means of identification and other than goods classified in the heading “Garments, clothing accessories and other products made of natural fur”. Alta Soft. Available at: https://www.alta.ru/tamdoc/22kr0100/ (accessed 04.03.2024) (in Russian).3.Pogarskaya A. S. Problematic aspects of customs regulation of imported medical device accessories. Problems of social hygiene, health care and the history of medicine. 2023;31(S1):813–9 (in Russian).4.Decree of the Government of the Russian Federation No. 137 dated 02/09/2022 “On conducting an experiment on labeling certain types of medical devices with identification means on the territory of the Russian Federation”. The Government of Russia. Available at: https://www.garant.ru/products/ipo/prime/doc/406872710/ (accessed 04.03.2024) (in Russian).5.FCS: The volume of detected counterfeit goods decreased by 2.2 times compared to last year. Alta Soft. Available at: https://www.alta.ru/external_news/104752/ (accessed 04.03.2024) (in Russian).6.Parallel import of medical devices in Russia: effective methods of struggle and practical recommendations for copyright holders in a crisis. 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