Monday, January 30, 2012 12:04 PM
New Regulations Imminent in Russia
Russian authorities are expected to implement new medical device regulations concerning authorized representation, vigilance, country-of-origin approval and other issues within the next several weeks.
According to Emergo Group’s Moscow office, Roszdravnadzor and the Russian Ministry of Public Health are still negotiating aspects of the new regulations pertaining to clinical studies. But the new rules are anticipated to include the following components: Authorized Representation may be required and if so, the Authorized Representative role in Russia will resemble the European arrangement, and will serve as the liaison between manufacturers and Roszdravnadzor for all vigilance-rel more...
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