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Ukraine's new medtech regulations in force, transition decision awaited

This article was originally published in SRA

Executive Summary

Delayed by a year, Ukraine's new system of conformity assessment and notified bodies for medical devices came into effect on 1 July 2015 - although uncertainty over transition arrangements and some doubts over the level of preparedness persist. But the Ministry of Health remained true to its word: in autumn 2014 it committed to introducing the three technical regulations/decrees, in replacement of the state system of registration, by Q3 20151.

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