Ukraine's new medtech regulations in force, transition decision awaited
This article was originally published in SRA
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.
You may also be interested in...
The weeks are ticking down until the launch of Ukraine's Declaration of Conformity (DoC)-based system of medical device regulation on July 1. Old certificates will be invalid after that date, and companies should not be banking on further delays to a system that has already been subject to deadline extensions.
The December 12 UK general election returned a Conservative majority, the scale or which few would have predicted. It means that the new government can press on with its plans for Brexit, the uncertainty now surrounding only when, not if.
ConMed’s ambitions in orthopedics are to be the clinician’s support, develop differentiated offerings and avoid “me too” activity, before all notions of leading the market rankings.