Tag Archives: Government

Roszdravnadzor: the terms of marketing authorisation and safety tests for medical devices conform to general world practice

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The state marketing authorisation of medical devices (medical device registration process) in the Russian Federation is carried out in accordance with the Rules of State Marketing Authorisation of medical devices, as approved by Order of the Government No. 1416 of the Russian Federation dated 27 December 2012 (hereinafter “the Rules”). The procedure for the state marketing authorisation of medical devices

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The Government has simplified the rules of State registration of medical devices

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The Federal Service for Surveillance in Healthcare informs about the adoption of the decree of the Government of the Russian Federation dated 31.05.2018 № 633 “On amendments to the Rules of State registration of medical devices”. The Government decree amended the Rules of State registration of medical devices № 1416 which were approved by the Government of the Russian Federation

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The manufacturer was fined 500 thousand roubles for supplying unregistered medical oxygen

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The manufacturer was fined 500 thousand roubles for supplying unregistered medical oxygen to a medical institution in Rostov. During a scheduled inspection the Territorial Division of Roszdravnadzor for Rostov region revealed that for a year Kislorod LLC had been supplying medical oxygen not included in the State Register of Medicines to one of the medical institutions of the region. After examining

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Fines for violations

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The Regional Dental Health Centre of Vladimir Oblast fined 200,000 roubles for violations identified by the Federal Service for the Supervision of Public Health and Social Development (Roszdravnadzor) during an unscheduled inspection As per an individual request in regards to the quality of dental medical services provided on a paid basis, the territorial authority of the Federal Service for the

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Attention, medical organizations and private entrepreneurs!

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As of December 12, 2017, resolution of the Government of the Russian Federation as of 18/12/2016 No. 1327 shall enter legal force, in accordance with which the following changes will be enacted in relation to the Regulation on the licensing of medical practice (with the exception of the indicated business conducted by medical organizations and other organizations included within a

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