Update on registration of medical devices in Russia and Ukraine

Important news on registration of medical devices in Russia and Ukraine. Roszdravnadzor has published official statistics on registration of medical devices in 2016.  A new order came into force recently in Ukraine regarding the procedure for keeping the registry.

At the end of March 2017, Russian medical device regulator Roszdravnadzor published statistics on registration of medical devices in 2016. It was reported that 1,465 new medical devices had been approved (around 40% more than the year before) – among them 559 (38%) products manufactured in Russia and 906 (62%) by foreign manufacturers.

According to the report, the number of registration refusals decreased by around 9% compared to the year before. Roszdravnadzor evaluates the total number of registration refusals for the year at 15.2%.

Kiev, Ukraine. On April 18^th came into force Order of Ministry of Health of Ukraine N122 dated 10.02.2017 “On approval of the Procedure for keeping the Registry…”

According to that Order information on manufacturers, Authorized Representatives of non-resident manufacturers should be submitted to the Registry according to a special form approved in Annex 2 to the Order: 

• for all class I medical devices (not sterile, without measuring functions), custom-made devices, systems and procedural packs, 
• for all medical devices for in-vitro diagnostics, 
• for all custom-made active implantable medical devices, 

before being placed on the market. 

Artikel: Roswitha Backes, E3M Business Consulting GmbH