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@article{202142,
        author = {MEDURI GAYATHRI and P G MANOJ and Y PARTHASARADHI},
        title = {COMPARATIVE STUDY OF MEDICAL DEVICE REGULATIONS: USFDA, EU MDR AND CDSCO},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {12},
        pages = {6451-6453},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=202142},
        abstract = {Medical devices are essential components of modern healthcare systems and are widely used for diagnosis, prevention, monitoring, treatment, and rehabilitation of diseases. These devices range from simple instruments such as thermometers and syringes to highly complex technologies such as implantable pacemakers, artificial intelligence-based diagnostic tools, and robotic surgical systems. Because medical devices directly impact patient safety and healthcare outcomes, regulatory frameworks are necessary to ensure that products entering the market meet required standards of safety, efficacy, quality, and performance.
Different countries have established their own regulatory systems for medical device approval and monitoring. The U.S. Food and Drug Administration regulates devices through the Center for Devices and Radiological Health (CDRH), while the European Union regulates devices under Medical Device Regulation (EU) 2017/745 through notified bodies and CE marking procedures. In India, medical devices are regulated by the Central Drugs Standard Control Organization under Medical Device Rules, 2017.
This study compares the regulatory frameworks of these three regions by evaluating classification systems, approval pathways, clinical investigation requirements, quality standards, post-market surveillance systems, and regulatory challenges. The findings reveal significant similarities in risk-based classification approaches but differences in regulatory structure, approval timelines, and documentation requirements. The study emphasizes the need for global harmonization to reduce duplication and improve international access to medical technologies.},
        keywords = {Medical Devices, USFDA, EU MDR, CDSCO, CE Marking, Regulatory Affairs, Device Approval, Quality Systems},
        month = {May},
        }