A Review on Medical Device Reporting: Navigating Voluntary Reporting System in Us FDA & India CDSCO

Medical device reporting (MDR) plays a critical role in ensuring the safety and efficacy of medical devices by identifying and addressing potential risks in a timely manner. While mandatory reporting is often emphasized, voluntary reporting serves as a complementary mechanism that enhances post-market surveillance by capturing adverse events and device malfunctions that might otherwise go unreported. This review provides a comprehensive analysis of voluntary medical device reporting systems in two major regulatory frameworks: the United States Food and Drug Administration (US FDA) and the Central Drugs Standard Control Organization (CDSCO) of India. The US FDA’s MedWatch program and India’s Materiovigilance Program of India (MvPI) are explored in detail, highlighting their regulatory foundations, reporting processes, and the role of stakeholders, including healthcare professionals, manufacturers, and patients. Both systems aim to improve drug safety but differ in regulatory enforcement and reporting mechanisms. This article underscores the importance of voluntary reporting as a proactive approach to enhancing patient safety and regulatory compliance.