Category Archives: News

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

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

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!

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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How and when expert centers will provide consultancy?

After one month there is still no any official information about consulting services for medical device registration process from expert center sides, neither about process nor about cost and procedure. Short information by link – Order of the Federal Service on Surveillance in Healthcare dated 19.07.2017 No 6478 (started 10.09.2017 – about consultancy in expert centers)

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Government control in Internet

Roszdravnadzor together with law enforcement authorities prevented illegal distribution of falsified, unregistered and counterfeit medicines through the Internet. 7 criminal proceedings have been initiated. Within the framework of interdepartmental interaction between 7 September to 17 September 2017, the Territorial body of Roszdravnadzor in Moscow and Moscow region, together with the Economic Security and Anti-Corruption Department in Moscow region, engaged in

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Illegal paid examinations and Roszdravnadzor inspection

Patients with strokes in a hospital of Azov (Rostov Region) were illegally referred to paid examinations. Based on the Roszdravnadzor inspection materials, the medical institution was fined 150,000 rubles. The Roszdravnadzor territorial body for Kaluga Region has carried out a scheduled inspection of the Central Municipal Hospital of Azov MBUZ (Municipal Budgetary Healthcare Institution). In the course of the supervision

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Order No. 403n of the Ministry of Health of Russia dated 11 July 2017

On 22 September 2017 Order No. 403n of the Ministry of Health of Russia dated 11 July 2017 came into effect in the territory of the Russian Federation Order No. 403n of the Ministry of Health of Russia “On approval of the rules for dispensing medicinal products for medical use, including immunobiological medicinal products by pharmacy organizations, individual entrepreneurs licensed

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Proposals of the Service aimed at organization of internal control of the medical activities’ quality and safety in medical organizations – first results

Roszdravnadzor summed up the preliminary results of implementation in 16 regions of the country of the Proposals of the Service aimed at organization of internal control of the medical activities’ quality and safety in medical organizations. On September 6, 2017, a working meeting of the participants of the Project “Introduction of the Roszdravnadzor’s Proposals on organization of internal control of

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Patient died, as assumed by the mass media, because of failure to timely provide medical care in nephrology discipline

Roszdravnadzor discovered violations in State Budgetary Healthcare Institution of Stavropol Territory “Municipal Clinical Hospital No. 3” of Stavropol, where a patient died, as assumed by the mass media, because of failure to timely provide medical care in nephrology discipline. The territorial body of the Federal Service for Supervision in the Sphere of Healthcare for Stavropol Territory has conducted an off-schedule

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Roszdravnadzor held public hearings on the compliance practice review results in the second quarter of 2017

On July 27, the Federal Service for Surveillance in Healthcare chaired by the Head of Roszdravnadzor Mikhail Murashko held public hearings on the compliance practice review results in the second quarter of 2017. The event covered the following issues: routine and large-scale violations of mandatory requirements revealed in the course of supervisory activities as part of the state control of

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