Tag Archives: government

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

  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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Roszdravnadzor revealed gross violation of legislation in the clinic where a young woman died during plastic breast surgery. The medical facility in question is closed down

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

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

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 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 the materials of the case, the Arbitration Court of Rostov region passed a ruling to institute administrative

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