Author Archives: beawire

Professional postgraduate education training “Clinical Studies (Investigations) of Medical Devices”

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  FGBU CMIKEE of the Federal Service for Surveillance in HealthCare will hold professional postgraduate education training “Clinical Studies (Investigations) of Medical Devices”. The Federal Service for Surveillance hereby informs you that the Federal State Budgetary Institution Center for Monitoring, Economic and Clinical Consultation, a division of the Federal Service for Surveillance in HealthCare, will hold additional professional postgraduate training “Clinical

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Introduction of changes in the registration dossier for biomedical cell products

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In the section “Biomedical cell products” of our web site there were published a lot of articles, devoted to the analysis of normative documentation and scientific articles related directly or indirectly to the registration of BMCP. This article is devoted to the process of making amendments in the registration dossier for the already registered BMCP. What can be changed? –

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Medical device approvals consulting

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The Federal Service for Surveillance in HealthCare reminds you that consultancy services for applicants regarding marketing authorisation of medical devices are held in two FBGU subordinate departments, namely in VNIIIMT and CMIKEE. The Federal Service for Surveillance in HealthCare would like to draw the attention of applicants for the state marketing authorisation of medical devices to the fact that related

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Telemedicine in Russia – review

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Russian Federation is the biggest country in the world by territory and it looks like telemedicine could be solution for connection healthcare specialists and patients. We started special topic about this: Why telemedicine is important as healthcare service? How it is regulated by government? Which products is considered to be medical devices for telemedicine? This is not full range of

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Import of biomedical cell product for the registration purposes

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In late May, the Government of the Russian Federation approved regulation 633 “On amendments to the Rules of State registration of medical devices”, according to which the registration dossier should now include sample import permission, which certainly affected the process of registration of medical devices. (More on the link). The beginning of the summer was also marked by news concerning

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Pharmaceutical substances and excipients

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There are a few groups of medical devices, which have pharmaceutical substances in their composition. For example, filers with hyaluronic acid or stents with immunosuppressors. (details by link) However, medical devices can contain not only pharmaceutical substances but excipients. According to Federal Law 61 “On circulation of Medicinal Products” excipients are substances of inorganic or organic origin used in the

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The Federal Service for Surveillance in HealthCare ceases cooperation with MFC

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Legal entities and/or private entrepreneurs intending to perform work (services) in the field of medical device circulation shall notify the Federal Service for Surveillance in HealthCare about the initiation of their operations. On 26 May, 2018, an Order of the Government of the Russian Federation was issued (No. 603), amending the list of public services which may be provided by

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Climatic zone classification for medical devices

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There is a standard GOST 15150 in Russian Federation, which regulates climatic conditions of manufactured devices. It contains normative values of ambient temperatures for different modifications of devices for different climatic areas. According to GOST R 50444 medical devices must comply with requirements of one of these climatic conditions: УХЛ4.2 (English abbreviation see in table below), У1, У1.1, У2, У3,

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Roszdravnadzor: Amendments to the Federal Law on the Circulation of Medicinal Products

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  Federal Law No. 140-FZ dated June 04, 2018 On Amendments to the Federal Law On the Circulation of Medicinal Products entering into force on June 15, 2018 has been designed to amend the procedure for the submission of documents for the purpose of the state registration of medicinal products, confirmation of the state registration, and introduction of amendments into

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