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The Mechanism of Recognition and Withdrawal of Unregistered Medical Devices from Circulation

The paper is devoted to the study of issues related to the powers of Roszdravnadzor to identify unregistered medical devices in circulation and to take response measures to limit their further sale and use by business entities. The authors analyze the features of the implementation of these powers of Roszdravnadzor and the problems arising in law enforcement practice. An analysis of the current Russian legislation leads the authors of the article to the conclusion that the legal regulation of the powers of Roszdravnadzor to recognize the products as unregistered and to make administrative decisions to restrict their circulation on the territory of the Russian Federation is insufficient and contradictory. The lack of proper legal regulation in this area entails negative legal consequences for participants in civil turnover. On the basis of the study, the authors formulates specific proposals for improving the legal regulation of the recognition and withdrawal from circulation of unregistered medical devices using mechanisms of preliminary and subsequent administrative (extrajudicial) and judicial control.