On 28 March 2017, the MOH abolished a number of bylaws related to the state registration of medical devices by Order No. 51 dated 23 January 2017. Specifically, the following MOH orders were declared invalid: (i) No. 478 On Approval of the List of Medical Devices Subject to State Registration (Re-Registration) in Ukraine, dated 2 July 2012; (ii) No. 979 On Approval of the Procedure for Importing Unregistered Medical Equipment and Medical Devices, dated 30 November 2012; and (iii) No. 616 On Approval of the Procedure for Conducting Clinical Trials of Medical Equipment and Medical Devices and of the Model Regulation on the Ethics Committee, dated 3 August 2012.
These bylaws were abolished because the procedure for state registration of medical equipment and medical devices has been replaced by a conformity assessment procedure based on the Technical Regulations. During the transitional period, ie, until 1 July 2017, medical devices may remain in turnover if they hold either the state registration certificate or the conformity assessment documents.