1. Introduction The labeling of medical devices shall be a matter of crucial importance for the design, development, manufacturing and virtually every other phase of life cycle of medical devices, particularly during the operational period. However in real life, as one can see, manufacturers either do not duly care about label contents and description, or take every effort in order
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An extensive group of medical devices (MDs) includes completely different products that may include different components. In the section devoted to MD, articles about drugs as part of MD have been published more than once (here and here). However, in addition to medicinal substances, various components of animal origin can be included in MD. Product overview Among the MD, which
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Order № 633 “On the introduction of amendments to the Rules of state registration of medical devices” came into force in June 2018. This normative document introduced the amendments to the range of important processes, including the confirmation of sample import. According to the Order, from now on the registration dossier should contain the hard copy of the sample import
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В настоящее время регистрация медицинских изделий, в состав которых входят лекарственные средства, является темой для обсуждения многих производителей, дистрибьюторов, и других участников рынка медицинских изделий . (См. статью «О лекарственных средствах в составе медицинских изделий и трудностях регистрации»). Трудности регистрации, появившиеся в связи с изменением российского законодательства, коснулись и такой группы изделий как внутрисосудистые стенты с лекарственным покрытием. Стенты, выделяющие
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At the present time registration of medical devices containing pharmaceutical substances is the topic for discussion for many manufacturers, distributors and other participants of the medical device market (see the article About pharmaceutical agents in the composition of medical devices and registration difficulties). Difficulties in the registration connected with the changes of Russian regulation touched upon drug-eluting intravascular stents. Stents capable
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В марте 2017 года вступил в силу приказ 11н «Об утверждении требований к содержанию технической и эксплуатационной документации производителя (изготовителя) медицинского изделия». В этом документе, в том числе изложены требования к документации на изделие, в состав которого входят лекарственные средства. Однако трактовка данных требований со стороны Росздравнадзора многократно осложнила процесс регистрации таких изделий. В сентябре 2017 года 38 компаний производителей
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In March 2017, Order 11n “On the Approval of the Requirements Imposed on the Contents of the Technical and User Documentation Provided by the Manufacturer (Maker) of a Medical Device,” came into force. This document specifies the requirements to the technical and user documentation for medical devices including those which contain drugs. However the interpretation of these requirements by Roszdravnadzor
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