ABSTRACT

The purpose of this article is to assess the present situation of medical device remanufacturing while taking into account the differences between the USFDA and the UK MHRA. Medical instruments and equipment are essential in today's health-care institutions. Following up with the invention of new technologies, on the other hand, is impractical for many health institutions, particularly in low-resource settings. As a result, global demand for remanufactured medical equipment is expanding. While new medical equipment is governed by well-established and severe quality and safety regulations, remanufactured medical device rules vary greatly among nations. In this section, we explore the various legislation and practices applicable to remanufactured medical equipment in the United States and the United Kingdom. The need for remanufactured medical devices has skyrocketed during the COVID-19 epidemic. For the purposes of this study, remanufacturing is the process of returning a used product to at least the original manufacturer's performance specifications. The customer's viewpoint and the resulting product are both given a warranty at least comparable to the guarantee of a newly manufactured equivalent. This obviously has significant implications for sustainability, since components that would otherwise be discarded may now be retrieved and of high quality. However, various social, economic, and regulatory issues influence these sustainability benefits. Regulatory rules for the import, sale, labelling, and use of a refurbished medical product are required, and authorities should follow these criteria to guarantee that remanufactured equipment meet high quality and safety standards. Keywords: Labelling, SUD, Changes, Performance, Process
Publication date: 01/08/2024

https://ijbpas.com/pdf/2024/August/MS_IJBPAS_2024_8273.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.8.8273