Category Archives: roszdravnadzor

The Federal Service for Surveillance in Healthcare stopped the implementation of unregistered medical devices, as well as the carrying out of illegal plastic surgeries, at the specialized exhibition of the beauty industry “INTERCHARM Professional” in Moscow

On 19 April 2019 the territorial body of the Federal Service for Supervision in Healthcare in Moscow and the Moscow region, together with law enforcement agencies, conducted control and supervisory measures at a specialized exhibition for professionals of the beauty industry and salon business “INTERCHARM Professional”, which was held on the territory of the Crocus Expo exhibition complex in Moscow.

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As a result of joint actions by the Federal Service for Supervision in Healthcare and law enforcement agencies in the Orenburg region, illegal activities to manufacture and market an unregistered medical device were stopped.

As a result of control and supervisory measures the territorial body of the Federal Service for Supervision in Healthcare in the Orenburg region exposed the production of an unregistered medical device Emplastrum “Silver Bridges” in the city of Gai. Information on the illegal production was sent to the Ministry of Internal Affairs of Russia in the Orenburg region to make a

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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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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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Medical device approvals consulting

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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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

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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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