Articles with tag: «registration of medical devices»

    International experience
  • 2020 № 7 Issues of regulation of handling of medical products in the mar kets

    The work outlines some of the provisions of the Project of the Commission of the Eurasian Economic Union: “On Amending the Rules for Registration and Examination of the Safety, Quality and Efficiency of Medical Devices”, provides an analysis of the prospects of the Project, its impact on the efficiency of circulation of medical devices in the territories of the countries of the Eurasian Economic Union. Based on the results of the analysis, conclusions are drawn on the applicability and significance of the considered provisions of the Project. The aim of the work is to analyze the main provisions of the Project of the Commission of the Eurasian Economic Union: “On Amending the Rules for Registration and Examination of the Safety, Quality and Efficiency of Medical Devices” and the possibilities of their practical application. The following methods were used in the work, namely, general scientific: analysis and synthesis, systemic, profile-economic: marketing, controlling methods. The scientific novelty of the work lies in the generalization, analysis of the materials considered and in the formation of proposals for certain areas of the Project and conclusions on the development of integration in the medical industry of the countries of the Eurasian Economic Union, according to the results of the analysis.

    Authors: Roshchin D. O. [5] Plutnitsky A. N. [4] Gertsik Yu. G. [1]

    Tags: eurasian economic union2 medical devices examination for the quality and effectiveness1 reference state1 registration certificate1 registration of medical devices1 safety3

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