Time is running short for companies that still need to replace their pre-2013 Russian medical technology registration certificates with new versions, as provided for in the recent regulatory overhaul introduced with Resolution 1416.
Under new medtech registration procedures that came into force on Jan. 1, 2013, manufacturers will have to replace, by Jan. 1, 2017, their certificates for both medical equipment and medical products with medical device certificates – a new single category to replace the former categories