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Medical Device Regulation Change in Russia BY ANDREW VAHRADIAN, NOVEMBER 20, 2012

A meaningful overhaul in the structure of how medical devices are regulated in Russia is expected to take place in early 2013. The Russian Ministry of Health has approved new guildelines regarding medical device classification, importation and adverse event handling. Additionally, medical device vigilance processes, conformity assessments and underlying quality and safety issues are all under consideration, yet new orders would need to be approved before authorities would be able to implement tangible regulations.

One of the more significant modifications entails a less direct regulatory role for the leading medical device regulatory agency, the Roszdravnadzor, opting for a process in which clinical trial initiation and final approval decisions would be determined by “expert reviewers” alternatively.

Other noteworthy alterations include a lack of timelines for medical testing, potentially resulting in timelines that could in some cases last for a period of years, and the incorporation of medical device registration fees as written law.

Final implementation of the amendments has not been communicated at this time. Whether the new rules will have a positive or negative effect on the Russian medical device industry, is unclear.

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