What is “Unregistered Medical Device” in Russia?

As is known, at the beginning of 2015, Russia adopted the Federal Law # 532 (link in Russian) and implemented amendments to the Russian civil and penal codes enacted stiffer criminal penalties of up to 2,000,000 rubles (app. $30,000) and a jail term of up to 12 years (for aggravating circumstances) for the manufacturing, sale or trade of counterfeit and unregistered pharmaceuticals and medical devices. In August 2015 Russian medical device expert organization VNIIMT held a seminar about control of circulation of medical devices and clarified, what medical devices are considered as “unregistered” and may come under jurisdiction of this law.

Here is the slide: