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@article{204638,
        author = {P Bhavya},
        title = {Comparative Analysis of Medical Device Regulations And Approval Pathways in the United States, European Union, And India},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {3414-3417},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=204638},
        abstract = {Medical devices play a crucial role in modern healthcare by supporting disease diagnosis, prevention, monitoring, and treatment. The increasing complexity and innovation in medical device technology necessitate robust regulatory frameworks to ensure device safety, quality, efficacy, and performance. Regulatory authorities across different regions have established distinct systems for device classification, approval, quality management, clinical evaluation, and post-market surveillance. This study provides a comparative analysis of medical device regulations and approval pathways in the United States, European Union, and India. The review examines regulatory structures, device classification systems, approval mechanisms, quality requirements, clinical evaluation standards, post-market surveillance programs, and traceability systems. The U.S. Food and Drug Administration (USFDA), European Union Medical Device Regulation (EU MDR 2017/745), and India's Medical Device Rules (MDR), 2017 have adopted risk-based approaches to ensure patient safety while promoting innovation. Although significant differences exist in regulatory implementation, all systems emphasize lifecycle management, quality assurance, and continuous safety monitoring. Greater harmonization among global regulatory frameworks may reduce regulatory burden, facilitate innovation, and improve patient access to safe and effective medical technologies.},
        keywords = {Medical Devices, Regulatory Affairs, USFDA, EU MDR, CDSCO, Device Approval Pathways, Clinical Evaluation, Post-Market Surveillance, Quality Management Systems.},
        month = {June},
        }