Russia Decides Pre-2013 Device Clinical Trials Can Support Marketing Approval
Russia's Federal Service on Healthcare Surveillance (Roszdravnadzor) and the Ministry of Health have agreed that clinical trials conducted on medical devices prior to January 2013 can be used to support applications for the renewal of or new marketing registration for devices in the 2013-2014 timeframe.
This comes as part of the agency's ongoing initiative to simplify the device registration procedure following consultations with industry in which concern was expressed about the existing re-registration process.
Commenting on the agency's decision, acting Roszdravnadzor head MichaelMurashko noted, "The theme of simplifying registration procedures is highly relevant today … with two main goals: to ensure the marketing of medical products with proven efficacy and safety, and to harmonize Russian legislation with that of developed countries."