CLASSIFIER OF MEDICAL DEVICES NC 024:2023: NATIONAL SYSTEM OF CLASSIFICATION OF MEDICAL DEVICES AND ITS USE IN UKRAINE
DOI:
https://doi.org/10.11603/1681-2786.2023.4.14424Keywords:
national classifier of medical devices, terms, methodological approaches to classification, useAbstract
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.
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].
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].
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2024 Bulletin of Social Hygiene and Health Protection Organization of Ukraine
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish in this journal agree to the following terms:
1. The authors reserve the right to authorship of the work and pass the journal right of first publication of this work is licensed under a Creative Commons Attribution License, which allows others to freely distribute the work published with reference to the authors of the original work and the first publication of this magazine.
2. Authors are entitled to enter into a separate agreement on additional non-exclusive distribution of work in the form in which it was published in the magazine (eg work place in the electronic repository institution or publish monographs in part), provided that the reference to the first publication of this magazine.
3. Policy magazine allows and encourages authors placement on the Internet (eg, in storage facilities or on personal websites) manuscript of how to submit the manuscript to the editor and during his editorial processing, since it contributes to productive scientific discussion and positive impact on the efficiency and dynamics of citing published work (see. The Effect of Open Access).
