Archive

2021/03

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Sergey GLAGOLEV: “The new regulation on federal state control over the circulation of medical devices is intended to shift the focus from inspections to the prevention of violations by business entities”
S. V. Glagolev
Medical devices: looking ahead for regulatory practices
A. V. Samoylova, D. Yu. Pavlyukov
State control over the circulation of medical devices. Results
M. A. Migeeva
Conducting federal state control over the circulation of medical devices in accordance with the new legislation
M. A. Migeeva, V. N. Kudzhaev, M. V. Borbutko
Legal regulation of the circulation of the software as a medical device
T. O. Pika, M. M. Sukhanova
Development of a national system for monitoring the safety of medical devices. Strengthening control over the safety of medical devices by their manufacturers
T. V. Ivanova, A. A. Kamaletdinova, E. V. Borisova, D.T. Sharikadze, O. A. Tarasenko
General requirements for the safety and effectiveness of medical devices as the basis for the formation of a registration dossier of a medical device in order to register it within the framework of the Eurasian Economic Union
T. O. Pika, M. M. Sukhanova
Specifics of preparing a report on clinical evidence of the effectiveness and safety of medical devices (with the exception of medical devices for in vitro diagnostics) in order to register them within the framework of the Eurasian Economic Union
T. O. Pika, M. M. Sukhanova
Artificial lung ventilation devices: assessment of compliance with quality and safety requirements
D.T. Sharikadze, O. A. Tarasenko, A.A. Rybalov, K.M. Frantsuzova, I. A. Pavich
Development of the testing center of the FSBI “VNIIIMT” of Roszdravnadzor within the framework of the national project “International cooperation and export”
D.T. Sharikadze, M. A. Migeeva, O. A. Tarasenko, A.A. Rybalov
Features of registration of medical devices on the territory of the Russian Federation during the COVID-19 coronavirus infection pandemic
E. A. Vorobyova, M. M. Sukhanova
Interim results of registration of a series (batch) of medical devices for in vitro diagnostics in 2020–2021
K. T. Momynaliev, I. V. Ivanov
Changes of the procedure of medical devices import into the territory of the Russian Federation for the purpose of their state registration
T. D. Kuznetsova
Медицинские изделия для диагностики in vitro для молекулярного тестирования в онкологии
K. T. Momynaliev, I. V. Ivanov
Medical devices for in vitro diagnostics for molecular testing in oncology
S. A. Zakharov, S. V. Podkolzin
Assessment of human resourcing and staffing level of medical organizations of the outpatient-polyclinic link of the Central Federal District with oncologists
I. A. Boyarskaya, D. S. Spiridonov, V. V. Kulakov, V. V. Ushenin, E. A. Shalaeva, D. A. Samofalov