The Unique Device Identification (UDI) system is a widely accepted access uniquely determining
medical apparatus, boosting post-market surveillance, and improving patient safety. This review
article comprehensively examines the landscape surrounding UDI implementation in different
countries. With an increasing focus on the harmonization of medical device regulations, this study
offers insights into the similarities and disparities in UDI adoption across various regions. The
analysis encompasses key aspects of UDI implementation, including regulatory requirements,
timelines for compliance, data standards, and enforcement mechanisms. The review covers major
markets like the United States, European Union, India, and Global IMDRF countries. It critically
evaluates the UDI systems strengths, challenges, and impacts on the healthcare industry and
regulatory authorities. Furthermore, the article highlights successful case studies of countries that
have effectively integrated UDI into their healthcare systems, leading to improved traceability,
reduced counterfeiting, and enhanced patient outcomes. Additionally, it examines the complexities
associated with implementing UDI requirements in diverse healthcare settings, such as resource-
constrained environments. On completion, this review article presents a comprehensive overview
of the regulatory landscape of Unique Device Identification for medical devices in different
countries. It emphasizes the importance of continued efforts toward standardization, collaboration,and adaptation to the dynamic nature of medical technology. In the end, UDI's generalization is
vital to guaranteeing patient security and promoting the worldwide medical device industry.
Keywords: IMDRF, AIDC, Safety, Technology, Global
Publication date: 01/09/2024
https://ijbpas.com/pdf/2024/September/MS_IJBPAS_2024_8303.pdf
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https://doi.org/10.31032/IJBPAS/2024/13.9.8303
