Volume : 12, Issue : 12, December- 2025
Title:
REGULATORY AND INFRASTRUCTURE CHALLENGES IN UDI IMPLEMENTATION ACROSS EMERGING ECONOMIES
Authors :
Helen Peter*, Mrs.Neeba Babu
Abstract :
Unique Device Identification (UDI) systems play a critical role in improving the traceability, safety, and overall management of medical devices throughout their lifecycle. A UDI consists of a Device Identifier (UDI-DI), which specifies the manufacturer and device model, and a Production Identifier (UDI-PI), which captures manufacturing details such as serial or batch numbers. Regulations require that UDIs appear on device labels in both human-readable and machine-readable formats using automated identification and data capture technologies. While regions such as the United States, European Union, Singapore, Brazil, and China have made substantial progress in establishing robust UDI frameworks, many emerging economies face persistent challenges. This study explores the key barriers to UDI adoption in emerging regions, particularly India, Southeast Asia, and Latin America. It examines regional differences, shared implementation obstacles, and insights gained from early adoption experiences. Understanding these challenges is vital for stakeholders aiming to strengthen UDI uptake and promote safer, more transparent global healthcare systems.
Keywords: Unique Device Identification (UDI), Medical Device Traceability, Regulatory Compliance, Regional Medical Device Regulation
Cite This Article:
Please cite this article in press Helen Peter et al., Regulatory And Infrastructure Challenges In Udi Implementation Across Emerging Economies, Indo Am. J. P. Sci, 2025; 12(12).
Number of Downloads : 10
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