Europe
Last Wednesday, as part of our monthly #WebinarWednesday series, RegDesk hosted an immensely informative presentation about recent changes to medical device regulations in the Eurasian Union. This month’s featured speaker, Eurasian regulatory expert Alexey...
Russia
Roszdravnadzor, the Russian regulating authority in the sphere of medical devices, has published the updated rules for evaluation of the software intended to be used for medical purposes. The document initially issued on February 12, 2021, and named “The...
Russia
An order of the Minister of Healthcare of the Russian Federation has been published. The order implements the administrative regulation the Roszdravnadzor shall follow when issuing establishment licenses to the entities engaged in manufacturing and maintenance of...
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...
