Tag Archives: News

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

Read more

The Federal Service for Surveillance in HealthCare ceases cooperation with MFC

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

Read more

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

Read more

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

Read more

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

Read more

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

Read more
« Older Entries