On December 22, 2022, Regulation of the Government of the Russian Federation No. 2374 dated December 22, 2022 “On amendments to the list of medical devices, the sale of which in the Russian Federation and import into the Russian Federation and other territories under its jurisdiction, are not subject to taxation (exempted from taxation) with value added tax”, which will
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With reference to the current economic situation, in April two resolutions of the Council of the Eurasian Economic Commission were adopted, namely No. 46 dated 5 April 2022 and No. 63 dated 12 April 2022, which changed the import duty rates for a particular group of goods. Pursuant to the above-mentioned resolutions, upon import of goods from the list an
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For the first time, the Federal Service for Surveillance in HealthCare is conducting remote inspection of medical device manufacturing located abroad. The FGBU VNIIIMT of Roszdravnadzor with the participation of Roszdravnadzor specialists began for the first time the remote inspection of medical device manufacturing located abroad (the manufacturing site, Tianjin Huahong Technology Co., Ltd, is located in the People’s Republic
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What kind of activities are the subject of State funding programs The State funding program is regulated by Rules for the Provision of funding from the federal budget for Russia-based organizations as amended by a Government Order dated 30 December, 2022. According to the aforementioned document, funding may be provided for the following types of projects: Various actions and processes,
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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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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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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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In connection with the recent tragic events attributed to plastic surgery, the Ministry of Healthcare of the Russian Federation has amended the requirements for the provision of medical assistance in the field of “plastic surgery.” On July 3, 2018, Order No. 298 N dated May 31, 2018 On Approval of the Procedure for the Provision of Medical Assistance in the
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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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After receiving information about the death of the woman after planned plastic breast surgery in the OOO Elit Clinic company facility, the local office of Roszdravnadzor in Moscow and Moscow Oblast conducted an unscheduled audit of the aforesaid medical facility. During the audit visit, multiple gross violations of the applicable legislation were discovered. In particular, two plastic surgeons (one of
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