ABSTRACT

The study explores the realm of medical devices, which exceeds a global count of 1.5 million, characterized by stringent safety standards. It delves into remanufacturing, scrutinizing US regulations and proposing a definition to ease access to functional equipment in developing nations. The differentiation between remanufacturing and servicing is pivotal, particularly in terms of cybersecurity and device safety. Investigating the regulatory landscape of medical equipment remanufacturing, this study is to examines the perspective of the United States Food and Drug Administration (USFDA). Given the limited regulatory framework in many developing countries, the role of the USFDA becomes pivotal in shaping the industry. The primary objective is to establish a clear and comprehensive definition for medical device remanufacturing within the US context. This, in turn, would promote standardized practices and instil confidence among consumers regarding remanufactured medical products. The envisioned definition holds significant potential for enhancing access to functional medical equipment through the practice of remanufacturing, particularly in resource-constrained regions. The process of determining remanufacturing activities involves a thorough evaluation of intended use changes, their impact on specifications, the necessity for new marketing submissions, and meticulous assessment of component specifications. In this endeavour, the utilization of risk management principles, encompassing estimation and hazard evaluation, proves indispensable. The essence of robust decision-making lies in documenting choices extensively, substantiated by validation data. This documentation serves to clarify how activities influence performance, safety specifications, and intended use. Keywords: USFDA, OEM, ISO, Medical Devices, Cybersecurity, Re- Manufacturing
Publication date: 01/08/2025

https://ijbpas.com/pdf/2025/August/MS_IJBPAS_2025_9316.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.8.9316