Ukraine Medical Device Industry Gets Hoped-For Transition
This article was originally published in SRA
The deadline by which medical devices can be imported and introduced into circulation in Ukraine using existing, state registration certificates has been extended by a year, until July 1, 2017.
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Ukraine's EU-aligned medtech regulatory system, using notified bodies and manufacturers' Declarations of Conformity (DoC), came into effect on July 1. The state retains a role in surveillance, but it no longer controls medtech registration; companies must now comply with three technical regulations (akin to the EU medical device directives) to access the medtech market in Ukraine.
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 MHRA has been working all hours to ensure the standalone medtech UKCA mark works operationally and procedurally in the UK as of 1 January 2021.