Russia The Roszdravnadzor, the medical device regulating authority of the Russian Federation, has published a guidance document dedicated to the methodical recommendations for the quality, effectiveness, and safety assessment of medical devices (in the part of medical...
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...
Europe The Roszdravnadzor, the Russian federal authority responsible for medical devices regulation, issued recommendations on quality, effectiveness, and safety examination of medical software for the purpose of state registration under the national framework. Eligibility...
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...
