Russia updated requirements for technical file and instruction for use for medical devices

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.

2 thoughts on “Russia updated requirements for technical file and instruction for use for medical devices

  1. Pingback: Three Things You Should Know about Medical Device Regulatory Changes in Russia in 2017 | Medical Device Regulations in Russia and Eurasian Union

  2. Pingback: Three Things You Should Know about Medical Device Regulations, April 2018 | Medical Device Regulations in Russia and Eurasian Union

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