Materiovigilance Programme of India: A scheme to assure cardiovascular devices safety surveillance

Abstract

The Materiovigilance Programme of India (MvPI) has been implemented to ensure the safety of medical devices including cardiovascular devices (MD-CVD). This article describes the role of MvPI surveillance system that comprehensively collects, collates and analyses the adverse events associated with MD-CVD and also its supplementing role to the Central Drugs Standard Control Organization for taking regulatory decision to reduce the health burden on account of adverse events due to medical devices to the patients based on the evidence based data. This article is expected to stimulate ethical reporting of adverse events due to MD-CVD at MvPI.

Keywords

• Materiovigilance
• Medical devices
• Adverse events
• Cardiovascular devices