Vol. 11 No. 1 (2019): Archives of Public Health
Public Health

Comparative analysis of materiovigilance systems of Macedonia, USА, EU, Japan and China and their role in public health

pdf (Македонски)
  • Vlatko Kokolanski,
  • Suzana Trajkovikj -Jolevska,
  • Rozalinda Isjanovska,
  • Kiro Ivanovski,
  • Katarina Dirjanska
Vlatko Kokolanski
Public health doctoral studies, Medical Faculty, University Sts. Cyril and Methodius, Skopje, Republic of North Macedonia
Suzana Trajkovikj -Jolevska
Faculty of Pharmacy, University Ss. Cyril and Methodius in Skopje, Republic of North Macedonia
Rozalinda Isjanovska
Institute of Epidemiology and Biostatistics, Faculty of Medicine, Ss Cyril and Methodius, Skopje, Republic of North Macedonia
Kiro Ivanovski
Faculty of Dentistry, University Ss. Cyril and Methodius in Skopje, Republic of North Macedonia
Katarina Dirjanska
Faculty of Dentistry, University Ss. Cyril and Methodius in Skopje, Republic of North Macedonia
DOI: https://doi.org/10.3889/aph.2019.2843

Published 2019-04-06

Keywords

  • public health,
  • materiovigilance,
  • medical devices,
  • safety,
  • best practices

How to Cite

1.
Kokolanski V, Trajkovikj -Jolevska S, Isjanovska R, Ivanovski K, Dirjanska K. Comparative analysis of materiovigilance systems of Macedonia, USА, EU, Japan and China and their role in public health. Arch Pub Health [Internet]. 2019 Apr. 6 [cited 2024 Dec. 18];11(1):20-3. Available from: https://id-press.eu/aph/article/view/2843
Copyright Notice

Abstract

Materiovigilance is a system applied for the purpose of detecting, gathering, monitoring, assessing and responding to new data on safety of medicinal products and related to the use of medical device related to possible incidents during use. The aim of this paper was to show the characteristics of the system of materiovigilance in the Republic of Macedonia compared to four other jurisdictions (US, EU, Japan and China), the recognition of the advantages and disadvantages of the systems and their impact on public health. Material and methods: For the realization of the aim of the study, we conducted an analysis of data published on the web pages of regulatory authorities related to the existing legal framework and review of the literature available on the network for scientists and researchers ResearchGate. General dialectical method as well as legal methods (dogmatic and normative method) were used in this study in order to determine the content, the meaning and the importance of the legal norms which regulate the system of materiovigilance. Results: The five systems of materiovigilance have several features that include monitoring of adverse events caused by medical device that have been granted a marketing authorization. Globally, these systems provide different, shared responsibility of all stakeholders. Thus, the scope of responsibilities of producers is significantly higher in Japan and China, opposed to the EU and Macedonia, where the responsibility is passed on to distributors, health professionals and other for-profit entities. United States is in the middle between these two extreme systems of materiovigilance, where the FDA has the responsibility to protect the public health forecasting responsibilities to the industry. Conclusion: There are significant variations in the regulation system of materiovigilance in the Republic of Macedonia and the analyzed legal systems. To date, there is no empirical evidence that one system is better than another, but it is indisputable that each system has its advantages and disadvantages regarding the protection of public health. Within the analyzed systems of materiovigilance three best practices can be seen that contribute to the improvement of public health: transparency, repeating the examination of medical device and central versus local control. 

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