Enhancing patient safety: Materiovigilance and medical device surveillance in India and global perspectives

Abstract

The post-marketing vigilance system for medical devices in India is not as robust as that for drugs. Materiovigilance, which focuses on monitoring and reporting adverse events associated with medical devices, is an essential aspect of post-marketing surveillance. Various countries, including India, have implemented their own post-marketing surveillance systems in accordance with the World Health Organization’s directives. In India, this system is known as the materiovigilance program of India (MvPI). This article aims to evaluate the current status of MvPI, compare it with the systems in developed countries, and propose specific measures to enhance the effectiveness of the program.