CLASSIFIER OF MEDICAL DEVICES NC 024:2023: NATIONAL SYSTEM OF CLASSIFICATION OF MEDICAL DEVICES AND ITS USE IN UKRAINE

Authors

  • G. О. Slabkiy Uzhhorod National University, Uzhhorod, Ukraine
  • R. L. Kartavtsev State Enterprize “Polytechmed”, Kyiv, Ukraine

DOI:

https://doi.org/10.11603/1681-2786.2023.4.14424

Keywords:

national classifier of medical devices, terms, methodological approaches to classification, use

Abstract

Purpose: to present methodological approaches to the classification of medical devices used in the creation of the national classifier of medical devices NC 024: 2022 and in its practical use.

Materials and Methods. Materials: international and national legislative and regulatory documents on the classification of medical devices. Methods: bibliosemantic, of systemic approach and of structural-and-logical analysis.

Results. The national classifier of medical devices NK 024:2023 is intended for the identification of tools, devices, devices, devices, materials or other medical devices. The national classifier of medical devices NK 024:2023 is an adapted translation of a part of the list of medical devices included in the Global Medical Device Nomenclature (GMDN) nomenclature and supplemented by medical products not included in the GMDN nomenclature, but used in Ukraine.

In the course of the study, methodological approaches to the classification of medical devices, which were used in the creation of the national classifier of medical devices NC 024: 2023 and in its practical use, were identified and presented in the article.

Conclusion. The national classifier 024:2023 is designed to identify instruments, apparatus, devices, materials or other products belonging to medical devices with the use of international methodological approaches to its development and is a relevant national standard.

Author Biographies

G. О. Slabkiy, Uzhhorod National University, Uzhhorod, Ukraine

DM (Medicine), Professor, Acting Head of the Department of Public Health, Uzhhorod National University

R. L. Kartavtsev, State Enterprize “Polytechmed”, Kyiv, Ukraine

PhD (Medicine), General Director of the State Enterprise "Politekhmed"

References

Mizhnarodna nomenklatura medychnykh vyrobiv GMDN [Global Medical Device Nomenclature]. Retrieved from: https://www.gmdnagency.org/ [in Ukrainian].

Nakaz Minekonomiky Pro zatverdzhennya natsionalnoho klasyfikatora NK 024:2023 ta skasuvannya natsionalnoho klasyfikatora NK 024:2019 vid 24.05.2023 r. № 4139 [Order of the Ministry of Economy of Ukraine On the approval of the national classifier NC 024:2023 and the repeal of the national classifier NC 024:2019 dated 24.05.2023 No. 4139]. zakon.rada.gov.ua. Retrieved from: https://zakon.rada.gov.ua/rada/show/v4139930-23#Text [in Ukrainian].

Nakaz Ministerstva ekonomichnoho rozvytku i torhivli Ukrayiny Pro zatverdzhennya natsionalnoho klasyfikatora Ukrayiny DK 021:2015 ta skasuvannya natsionalnoho klasyfikatora Ukrayiny DK 021:2007 vid 23.12.2015 r. № 1749 [Order of the Ministry of Economic Development and Trade of Ukraine On the approval of the national classifier of Ukraine DK 021:2015 and the repeal of the national classifier of Ukraine DK 021:2007 dated 23.12.2015 No. 1749]. zakon.rada.gov.ua. Retrieved from: https://zakon.rada.gov.ua/rada/show/v1749731-15#Text [in Ukrainian].

Tekhnichnyy rehlament shchodo aktyvnykh medychnykh vyrobiv, yaki implantuyut [Technical Regulation on Medical Devices]. Postanova Kabinetu Ministriv Ukrayiny vid 02.10.2013 r. № 755 – Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 No. 755. zakon.rada.gov.ua. Retrieved from: https://zakon.rada.gov.ua/laws/show/753-2013-%D0%BF#Text [in Ukrainian]. DOI: https://doi.org/10.1149/MA2013-02/10/755

Tekhnichnyy rehlament shchodo medychnykh vyrobiv dlya diahnostyky in vitro [Technical Regulation on In Vitro Diagnostic Medical Devices]. Postanova Kabinetu Ministriv Ukrayiny vid 02.10.2013 r. № 754 – Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 No. 754. www.kmu.gov.ua. Retrieved from: https://www.kmu.gov.ua/npas/246787748 [in Ukrainian].

Tekhnichnyy rehlament shchodo medychnykh vyrobiv [Technical Regulation on Active Implantable Medical Devices]. Postanova Kabinetu Ministriv Ukrayiny vid 02.10.2013 r. № 753 – Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 No. 753. zakon.rada.gov.ua. Retrieved from: https://zakon.rada.gov.ua/laws/show/755-2013-%D0%BF#Text [in Ukrainian]. DOI: https://doi.org/10.1149/MA2013-02/10/753

Published

2024-02-13

How to Cite

Slabkiy G. О., & Kartavtsev, R. L. (2024). CLASSIFIER OF MEDICAL DEVICES NC 024:2023: NATIONAL SYSTEM OF CLASSIFICATION OF MEDICAL DEVICES AND ITS USE IN UKRAINE. Bulletin of Social Hygiene and Health Protection Organization of Ukraine, (4), 37–41. https://doi.org/10.11603/1681-2786.2023.4.14424

Issue

Section

Organization of medical care