Regulatory Framework for Medical Devices in India

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This study explores six categories of Indian medical devices, employing a mixed-methods approach and international benchmarks to identify key gaps in classification and surveillance. Findings highlight quality assurance issues in imaging tests and propose quality checkpoints for PET and cell separators, exemplified by ISO 15197:2013 for glucose meters. Recommendations include establishing a new MDR category for neuroprosthetic vision aids, enhancing CDSCO checklists, and advocating for robust...