Implementation of the classification of medical devices of Ukraine in international approaches

Author:

Slabkiy Gennadiy O.1,Bilak-Lukyanchuk Victoria J.1,Kartavtsev Rostislav L.2,Kondratskyi Vitalii3

Affiliation:

1. UZHHOROD NATIONAL UNIVERSITY, UZHHOROD, UKRAINE

2. STATE UKRAINIAN ASSOCIATION “POLYTECHMED”, KYIV, UKRAINE

3. CARDINAL STEFAN WYSZYNSKI UNIVERSITY, WARSZAWA, POLAND

Abstract

Aim: To study the level of compliance of the National Classifier of Ukraine ≪Classifier of Medical Devices of Ukraine NC 024: 2023≫ with international approaches to the classification and use of medical devices. Materials and Methods: National Classifier of Ukraine ≪Classifier of Medical Devices of Ukraine NC 024: 2023≫ and the international nomenclature of medical devices Global Medical Device Nomenclature. Methods: bibliosemantic, of content analysis and of structural-and-logical analysis. Conclusions: In the course of the study, full compliance of the national classifier of medical devices of Ukraine NC 024: 2023 with the GMDN system was established.

Publisher

ALUNA

Reference9 articles.

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2. 2. Regarding medical devices for in vitro diagnostic, Directive 98/79/EC of the European Parliament and of the Council]. 1998. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A31998L0079 [Accessed 27 November 2023]

3. 3. CABINET OF MINISTERS OF UKRAINE RESOLUTION of October 2, 2013 No. 753 [On the approval of the Technical Regulation on medical devices Technical Regulation on Medical Devices, Resolution of the Cabinet of Ministers of Ukraine №753]. 2013. https://zakon.rada.gov.ua/laws/show/753-2013-%D0%BF#Text [Accessed 27 November 2023] (Ukrainian)

4. 4. Postanova vid 2 zhovtnya 2013 r. № 754 Pro zatverdzhennya Tekhnichnoho rehlamentu shchodo medychnykh vyrobiv dlya diahnostyky in vitro [Technical Regulation on In Vitro Diagnostic Medical Devices, Resolution of the Cabinet of Ministers of Ukraine №754]. 2013. https://www.kmu.gov.ua/npas/246787748 [Accessed 27 November 2023] (Ukrainian)

5. 5. Kabinet Ministriv Ukrayiny. Postanova vid 2 zhovtnya 2013 r. № 755 Pro zatverdzhennya Tekhnichnoho rehlamentu shchodo aktyvnykh medychnykh vyrobiv, yaki implantuyut' [Technical Regulation on Active Implantable Medical Devices, Resolution of the Cabinet of Ministers of Ukraine №755]. 2013. https://zakon.rada.gov.ua/laws/show/755-2013-%D0%BF#Text [Accessed 27 November 2023] (Ukrainian)

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