ELIMINATION OF REMARKS IDENTIFIED BY ROSZDRAVNADZOR IN THE PROCESS OF MONITORING THE CIRCULATION OF MEDICAL DEVICES
The subject of state control over the circulation of medical devices is compliance with mandatory requirements for the circulation of medical devices, including:
requirements for technical tests, toxicological studies, clinical trials
production, manufacture, importation into the territory of the Russian Federation
conformity assessment
storage, transportation, sale, installation, commissioning, application, operation, including maintenance, repair, disposal and destruction
Requirements to the quality, safety and effectiveness of medical devices in circulation on the territory of the Russian Federation.
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Preparation and execution of a set of documents for making changes to the registration dossier in accordance with Health Authority remarks
Analysis of Roszdravnadzor regulations, preparation of clarifying requests
Development of a program of corrective actions
Support of corrective actions until a positive conclusion on the elimination of remarks is received
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INN: 7713477889, OGRN: 1207700364740
INN: 7713477889, OGRN: 1207700364740
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