Saturday, February 13, 2016 6:50:41 AM
techxen • 7 hours ago
Based on the responses of 2,062 industry professionals published in the Global Medical Device IndustryOutlook for 2016 by Emergo Group, Russia and China traditionally was most often cited as more difficult markets to enter. 58 percent of respondents consider that the process of obtaining regulatory approval for a medical device in Russia in 2015 became more difficult than before and only 2 percent of professionals believe that situation became better. Between January and September 2015 only 394 out of 601 new medical devices from foreign manufacturers were approved - 207 were rejected.
If the company has indeed obtained registration approval this month this would be one of their largest sales territories to date and a significant achievement. As a side note, INTENSIVMED are official dealers of Sorin GmbH heart-lung machines and PULSION Medical Systems SE both leaders in providers of cardiac surgery and critical care technologies, and with a large sales and network of sub-distributors that they cover the whole Russian Federation.
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