
Nov 30, 2021
Russia
Roszdravnadzor, the Russian regulating authority in the sphere of medical devices, has published a recently adopted regulation on state supervision and control. The document prescribes the way the regulating authority should perform its functions when supervising the...
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Nov 23, 2021
Russia
Roszdravnadzor, the Russian regulating authority in the sphere of medical devices, has published a regulation on state control (supervision) over the circulation of medical devices. The document sets forth the rules and requirements in the sphere of state supervision...
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Nov 12, 2021
Russia
Roszdravnadzor, the authority responsible for medical devices and other healthcare products allowed to be marketed and used in the Russian Federation, has published a regulation on state supervision over the circulation of medical devices. The appropriate resolution...
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Aug 14, 2020
Russia
Russian Ministry of Healthcare has issued an amendment to the regulation 4N dated June 6, 2012, on the classification of medical products. The amendment implements special rules to be applied to software with an intended medical purpose (medical software). The amended...
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May 14, 2020
Europe
The Russian Federation issued several regulations implementing additional measures to ensure and expand the availability of medical devices that are vitally important during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the...
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