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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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Within the framework of co-operation between Roszdravnadzor and the MIA of the Russian Federation, the re-selling of expensive medicinal drugs was identified, amounting to ca. 55 billion RUB

In the course of the joint action involving the Central Administration on Economic Security and Combatting Corruption of the MIA of the Russian Federation, the Regional Administration on Economic Security and Combatting Corruption of the MIA of the Russian Federation in Saint Petersburg and Leningradskaya oblast, with the recruitment of Roszdravnadzor personnel, the reselling of expensive medicinal drugs Mabtera and

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IAS for drugs

As a result of media requests regarding the functioning of the information and analytical system (IAS), the Ministry of Health of the Russian Federation and Roszdravnadzor report the following: At the present time, as part of the improvements being made to the State Procurement System, the Ministry of Health of the Russian Federation together with interested federal authorities, has been

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Aspects of Registration of Medical Devices Containing Pharmaceutical Drugs

Among the exceptional diversity of medical devices varying in their purpose, mechanism of action, design properties, complexity, technical and functional characteristics, a special category of devices should be singled out: devices containing pharmaceutical drugs. Any manufacturer intending to obtain state registration for such devices in the Russian Federation will find it useful to learn in advance about certain possible difficulties

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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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EAC mark – list of applicable standards

A list of standards which, on a voluntary basis, fully or partially ensure compliance of medical devices with the General requirements of safety and efficacy of medical devices, the requirements for their labeling and maintenance documents approved by the recommendation of the Eurasian Economic Commission panel. You could find recommendation #17 by link (in English) – EAC #17 (standards) ; (in Russian)

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