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@article{187304,
        author = {PALLA VISHWADA and BHUKYA NAGARAJU and PUNE SHIVANI and Dr.SUTHAKARAN},
        title = {THE PERFORMANCE OF A FEW MEDICAL DEVICES MADE IN INDIA AND OTHER NATIONS, ALONG WITH REGULATORY CONSIDERATIONS},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {6},
        pages = {4773-4785},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=187304},
        abstract = {The performance and regulatory compliance of medical devices are critical factors influencing patient safety, treatment outcomes, and healthcare efficiency. This study investigates the clinical performance of selected medical devices including IV cannulas, urinary catheters, intraocular lenses, and coronary stents manufactured in India and other nations. Data were collected from government and private hospitals across multiple cities, examining device utilization, efficacy, and patient outcomes. The study also evaluates regulatory considerations, comparing the Indian framework under the Medical Device Rules (2017) with international practices such as the U.S. FDA regulations. Results indicate that while Indian-made devices generally meet functional and safety standards, there are variations in performance metrics when compared to imported devices, particularly for high-risk devices like coronary stents and intraocular lenses. Government hospitals demonstrated higher usage due to accessibility and affordability, whereas private hospitals reported selective usage of specialized devices. The study underscores the importance of stringent regulatory compliance, post-market surveillance, and quality management systems to ensure safety and effectiveness. Furthermore, alignment with global standards is recommended to enhance the competitiveness of Indian medical devices in the international market. Overall, this research highlights the interplay between device performance, clinical outcomes, and regulatory frameworks, providing insights for policymakers, healthcare providers, and manufacturers.},
        keywords = {Medical Devices, Device Performance, Regulatory Compliance, Indian Medical Device Rules, U.S. FDA Regulations.},
        month = {November},
        }