International Journal For Multidisciplinary Research

E-ISSN: 2582-2160   •   Impact Factor: 9.24

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Clinical Investigations of High-Risk Medical Devices in India, Germany and Canada

Author(s) Ms. C A Ansitha, Rani.K.Kuriakose
Country India
Abstract High-risk medical devices, including implants and life-sustaining technologies, play a critical role in healthcare but also present substantial regulatory and clinical challenges. This paper provides a comparative analysis of India, Germany, and Canada, three countries representing different regulatory maturities and healthcare contexts. Using a qualitative comparative approach, the study reviewed regulatory policy documents, peer-reviewed literature, and international reports (2019–2025) to examine approval pathways, evidence generation, ethics oversight, operational barriers, and post-market surveillance mechanisms for high-risk devices. Results reveal that India, governed by the Medical Devices Rules (2017), has made progress toward harmonization but continues to struggle with infrastructure gaps, uneven ethics committee performance, and weak materiovigilance participation. Germany, under EU MDR, stands out for its rigor in clinical evidence requirements but is hampered by bottlenecks in notified bodies, compliance fatigue, and limited transparency for legacy devices. Canada demonstrates balanced oversight and innovation, with strong ethics and pioneering use of real-world evidence, though high costs and inter provincial fragmentation complicate trial efficiency. Despite differences, shared challenges include regulatory ambiguity, transparency gaps, difficulties in generating robust evidence, and incomplete post-market surveillance systems. The study concludes that global harmonization, stronger oversight mechanisms, and cross-country learning are essential to ensure safe, effective, and timely access to high-risk medical devices worldwide.
Keywords High-risk medical devices, Clinical investigations, Regulatory challenges
Field Medical / Pharmacy
Published In Volume 7, Issue 4, July-August 2025
Published On 2025-08-31
DOI https://doi.org/10.36948/ijfmr.2025.v07i04.54908
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E-ISSN 2582-2160
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