Roszdravnadzor Clarifies Requirements for Clinical Data for Registration of Class I Medical Devices.

clinical trialsOn 8th of September 2015, the Russian medical device regulator (Roszdravnadzor) clarified requirements for submission of clinical data for simplified approval process for Class I medical devices. For the fastest approval of low class devices, Roszdravnadzor previously recommended submitting in the registration dossier “documents confirming clinical efficiency and safety”. Today the agency confirmed that clinical data should mandatory come from the accredited Russian clinical centers listed in the database of Roszdravnadzor.  The Russian regulator highlights, that clinical reports should be designed according the procedure regulated by Decree 2N (link in Russian) and for the simplified registration process does not requires prior application for clinical trial authorization.

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