Ukraine Medtech At Last Crosses From State To DoC Regulatory System

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.

Magnifying glass with the Map of Ukraine with a blue pushpin stuckMap of Ukraine with a blue pushpin stuck

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