ABSTRACT

India's Materiovigilance Programme (MvPI) plays a pivotal role in ensuring the safety and efficacy of medical devices. Initiated in 2015, MvPI focuses on monitoring adverse events related to healthcare device usage, promoting awareness, and providing evidence-based recommendations for safe usage. The program's unique features include collaboration with medical colleges, an organized reporting structure, and a regulatory framework established in the Medical Device Rules of 2017. This article reviews the history, goals, and current status of MvPI, emphasizing its role in enhancing healthcare device safety in India. The program faces challenges, but ongoing efforts are vital for continued success. The article concludes with considerations for future improvements, emphasizing the need for increased engagement, awareness, and collaboration at various levels to strengthen Materiovigilance in India. Keywords: Adverse Event Reporting, Materiovigilance Programme (MvPI), Medical Device Safety, Postmarket surveillance
Publication date: 01/04/2025

https://ijbpas.com/pdf/2025/April/MS_IJBPAS_2025_8869.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.4.8869