ABSTRACT:
The widespread adoption of medical devices in modern healthcare has markedly improved patient care and clinical outcomes; however, it has simultaneously raised concerns regarding device-related adverse events. In response to these safety challenges, the Government of India initiated the Materiovigilance Programme of India (MvPI) in 2015, coordinated by the Indian Pharmacopoeia Commission (IPC), Ghaziabad. The programme is designed to systematically monitor, evaluate, and prevent adverse events associated with medical devices, thereby ensuring enhanced patient safety nationwide.This review presents a detailed overview of the Materiovigilance Programme of India, outlining its objectives, organizational framework, reporting pathways, and the critical role of healthcare professionals in adverse event reporting. Emphasis is placed on the significance of structured adverse event reporting in identifying potential device-related risks and facilitating evidence-based regulatory decisions. The existing reporting mechanism under MvPI, which includes voluntary reporting by healthcare professionals, manufacturers, and patients, is comprehensively discussed. Although notable progress has been achieved, several challenges continue to limit the effectiveness of MvPI, including under-reporting of adverse events, insufficient awareness, inadequate training, and limited incorporation of materiovigilance practices into routine clinical workflows. The review further highlights the future prospects of MvPI, stressing the importance of enhanced awareness initiatives, adoption of digital reporting platforms, and greater involvement of pharmacists and pharmacovigilance professionals. In conclusion, MvPI serves as a vital component in strengthening medical device safety in India. Promoting a robust reporting culture, continuous capacity building, and effective collaboration among all stakeholders is essential for the successful implementation of the programme and the safe utilization of medical devices within the healthcare system.
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