Author Archives: beawire

CAR-T therapy

 In the section devoted to biomedical cell products, much attention was paid mainly to the legal aspects of the circulation of this type of product, as well as to the basic procedures that make up the life cycle of BMCP. However, this article is devoted directly to BMCP – the newest and promising method of treatment of cancer, in particular

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Temporary import of some biomedical cell products is approved

The Russian government has introduced a temporary permitting procedure for the import into the Russian Federation of biomedical cell products (BMCP). The relevant decree of the Government of the Russian Federation of 16.10.2018 No. 1229 was signed by Prime Minister Dmitry Medvedev. Permission for temporary admission will be valid from November 1, 2018 to April 30, 2019 and will apply

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Medical devices that include components of animal origin

 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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Medical devices and telemedicine

After implementation of Federal Law, No 242-FZ dated 07.29.2017 “On the implementation of changes in certain legislative acts of the Russian Federation regarding the application of information technologies in healthcare” (also known as “the Telemedicine Act”), the question may emerge (and for many it has long since emerged): what is the proper definition for the term “telemedicinal device”. There are

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This Laboratory Services and Confidentiality Agreement is signed between the Pharmacopeial Convention of the USA and FGBU IMCEUAOSMP of Roszdravnadzor

On October 8, 2018, during the XXth Annual All-Russia Conference with International Participants “State Regulation of the Circulation of Medicinal Drugs and Medical Devices – FarmMedObrashchenie – 2018” (hereinafter FMO-2018), a Laboratory Services and Confidentiality Agreement was signed between the Pharmacopeial Convention of the USA and FGBU IMCEUAOSMP of Roszdravnadzor in the presence of Mr. Mikhail Murashko, the Head of

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Special aspects of import of medical devices, which include precursors of narcotic substances

In the medical device market, there is a large number of products that contain various chemicals in the composition – active pharmaceutical substances, ancillary substances, as well as precursors of narcotic substances. This article is devoted to the peculiarities of the import of such devices. What are narcotic substances and their precursors? According to Federal Law No. 3 “On Narcotic

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Import of medical device samples for the registration on the territory of Russian Federation

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

  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

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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