Nov 4, 2020
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...
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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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Jun 11, 2020
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...
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Oct 24, 2017
Consultant Post
Learn about changes to Russia’s medical device regulations and CIS harmonization efforts
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Jun 24, 2016
Europe
The Ministry of Health of the Russian Federation is the country’s regulatory body for healthcare concerns. They recently released a change in regulation for medical devices. All Medical Device Registration Licenses issued from 1 January 2007 to 31 December 2012...
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