Implementation of the classification of medical devices of Ukraine in international approaches
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1
Department of Health Sciences, Uzhhorod National University, Ukraine
2
,, STATE UKRAINIAN ASSOCIATION “POLYTECHMED”, Ukraine
3
Chair of Gynecology and Obstetrics, Cardinal Stefan Wyszynski University, Poland
Submission date: 2024-01-17
Acceptance date: 2024-02-11
Publication date: 2024-03-30
Wiadomości Lekarskie 2024;77(2):345-347
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ABSTRACT
The 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. Materials: 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.
Results. In the course of the study, it was found that according to the Global Medical Device Nomenclature, each of the positions of the National Classifier of Ukraine "Classifier of Medical Devices of Ukraine NC 024: 2023" consists of five parts: code, product name in Ukrainian, product description in Ukrainian, product name in English, product description in English. At the same time, the name and description of the product in English is fully consistent with Global Medical Device Nomenclature.
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.
KEY WORDS: Ukraine, medical devices, classification, international approaches, compliance.