phОбщественное здоровьеPublic Health2782-16762949-1274ФГБУ «ЦНИИОИЗ» Минздрава России10.21045/2782-1676-2021-2-3-16-24ph-59Research ArticleТЕОРИЯ ОБЩЕСТВЕННОГО ЗДОРОВЬЯPUBLIC HEALTH THEORYБезопасность обращения медицинских изделий на всех этапах их жизненного циклаSafety of handling of medical devices at all stages of their life cyclehttps://orcid.org/0000-0003-2263-578XЗиновьева Е.  В.ZinovyevaE. V.

Евгения Владимировна Зиновьева – преподаватель учебно-методического отдела 

г. Москва

Evgeniya V. Zinovyeva – teacher of the educational and methodological department 

Moscow

evgzinoveva@yandex.ruhttps://orcid.org/0000-0002-1058-4463Сапунова А.  В.SapunovaA. V.

Сапунова Анна Владимировна – руководитель центра мониторинга безопасности медицинских изделий, экспертизы медицинских изделий, инспекции производства медицинских изделий 

г. Москва

Anna V. Sapunova – Head of the Center for monitoring the Safety of Medical Devices, examination of Medical Devices, inspection of the Production of Medical Devices 

Moscow

asapunova@vniiimt.orgИванов И.  В.IvanovI. V.

Иванов Игорь Владимирович – генеральный директор, д.м.н. 

г. Москва

Igor V. Ivanov – Director, Dr. of Sci. (Medicine) 

Moscow

ФГБУ «Национальный институт качества» РосздравнадзораРоссияNational Quality Institute of RoszdravnadzorRussian FederationФГБУ «Всероссийский научно-исследовательский и испытательный институт медицинской техники» РосздравнадзораРоссияFGBU «VNIIIMT» of RoszdravnadzorRussian Federation202206092022231624Copyright © Зиновьева  Е.В., Сапунова  А.В., Иванов  И.В., 20222022Зиновьева  Е.В., Сапунова  А.В., Иванов  И.В.Zinovyeva E.V., Sapunova A.V., Ivanov I.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://ph.elpub.ru/jour/article/view/59

В обзоре отражены основные моменты жизненного цикла медицинского изделия, рассмотрены три этапа регулирования медицинских изделий: предрыночный, рыночный и постпродажный. Основное внимание уделено постпродажному надзору, как деятельности по мониторингу используемых медицинских изделий, сбору информации о качестве, безопасности и эффективности медицинских изделий.

The review describes the main points of the life cycle of a medical device, considers three stages of regulation of medical devices: pre-market, market and post-sale. The main attention is paid to post-sale supervision, as an activity for monitoring used medical devices, collecting information about the quality, safety and effectiveness of medical devices.

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The authors declare that there are no conflicts of interest present.