Beawire MD regulation

New requirements for technical documentation and IFU for national registration process in Russia

Roszdravnadzor published new requirement for technical file (technical document or technical documentation) and user manual (instruction for use) - these new requirements will be started from 24 of March 2017.

Roszdravnadzor published new requirements for technical file (technical document or technical documentation) and user manual (instruction for use) – these new requirements will be started from 24 of March 2017. This document contains the first (!) official requirements under Order of Russian Government 1416.

All dossiers for state registration submitted from 24 of March must conform new requirements.

See Order of Minzdrav 11n from 19.01.2017 (registered 10.03.2017):

Приказ МЗРФ 2017 № 11н_зарегистрирован МЮ (1) – Russian version (full),

11n from 10.03.2017 – in English (full version).