On 15 March 2017 the Russian Ministry of Health released the Order #11N ( link in Russian) with full list of requirements for technical file and instruction for use for a medical and in-vitro devices.
It is the first time when these requirements is published as official regulation – until today they were available only as recommendation or voluntary standard, which different interpretation was one of the most common reasons of registration delays.
According to the document the requirements are applicable both for registration and for other stages of a medical device life-cycle.