Ministry of Health Invokes the Termination of the Number of Orders due to the Cancelation of Medical Devices’ Registration in Ukraine

On October 07, 2016, the Ministry of Health at its web-site provided for public consideration the Draft MOH Order «On the Annulment of Orders of the Ministry of Health of Ukraine on State Registration of Medical Devices» (hereinafter – the «Draft»).

The Draft provides for the annulment of the following orders:

• MOH Order № 478 dated 02.07.2012 «On Approval of the List of Medical Devices Subject to State Registration (Re-registration) in Ukraine»;
• MOH Order № 979 dated 30.11.2012 «On Approval of the Procedures on Import to the Territory of Ukraine of Unregistered Medical Devices»;
• MOH Order № 616 dated 03.08.2012 «On Approval of Rules of Conduct of Medical Devices’ Clinical Trials and of Model Regulation on Ethics Commission».

It is worth to mention that the state registration of medical devices in Ukraine has been terminated since July 01, 2015. In a year, starting from July 01, 2016, such registration gave place to the assessment of medical devices’ compliance with the relevant technical regulations (including for in vitro diagnostics and active implanted medical devices).

Therefore, the adoption of the Draft and consequent termination of the abovementioned orders shall not influence the daily operations of business representatives. At the same time, such steps mitigate even the lowest risks of inducing the companies to undergo the procedures that are not required by Ukrainian law anymore.