Tag Archives: medical product manufacturer

Ministry of Health adopts lists of data in the technical and operational documentation for a medical device

The Order of Ministry of Healthcare of Russia dated 19.01.2017 No. 11n “On approval of requirements to the content of technical and operational documentation of the medical product manufacturer (producer)” (hereinafter – the “Requirements”) became effective on 24 March 2017.

Previously clause 3 article 38 of the Federal law dated 21.11.2011 No. 323-FZ “On basics of health protection of citizens in the Russian Federation” was limited to state, that the Requirements are established by the authorized federal executive body.

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