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New aspects in MD regulations in the Russian Federation Amiran Preobrazhenskiy PreobrazhenskiAV@roszdravnadzor.ru Amendments in the scheme of MD pre-market approval Order of the Ministry of Health from 03.06.2015 303 On amendments

  1. New aspects in MD regulations in the Russian Federation Amiran Preobrazhenskiy PreobrazhenskiAV@roszdravnadzor.ru

  2. Amendments in the scheme of MD pre-market approval Order of the Ministry of Health from 03.06.2015 № 303н « On amendments into the Order of the Ministry of Health from 21 december 2012 г. N 1353н « On improvement of the order of organization and conducting the expertise of quality, effectiveness and safety of MD» Entered into force since 17.07.2015 The process of pre-market approval of MD of 1 st class of risk will be proceeded in 1 stage 2

  3. T HANK YOU 3

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