Major changes to Russian medical device regulations planned for 2013

November 8, 2012 by MassDevice

Global Medicine

By Stewart Eisenhart, Emergo Group

Significant changes to how medical devices are regulated in the Russian Federation are slated for early 2013, but final implementation of the new rules remains tentative.

The Russian Ministry of Health has already approved new orders regarding medical device classification, importation and adverse event handling. Also under consideration are medical device vigilance processes, conformity assessments as well as quality and safety issues. All orders under consideration must be approved before authorities begin implementing actual regulations.

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Some of the most important changes that may come about include a less direct regulatory role for Roszdravnadzor—final approval decisions will be made by “expert reviewers” rather than the regulator; lack of timelines for medical testing, meaning they could last for years; and inclusion of medical device registration fees into written law.

However, exact implementation timeframes for the new regulations are not yet clear. We will keep you informed of new medical device regulatory developments in Russia as we learn them.

Based on discussions with Russian Ministry of Health and Roszdravnadzor officials, Emergo Group has learned that the following changes to the Russian regulatory process may occur next year:

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