Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India, Sector 23, Raj Nagar, Ghaziabad, UP, 201002, India.
Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, 700073, India.
Indian Heart J. 2020 Jul-Aug;72(4):316-318. doi: 10.1016/j.ihj.2020.06.009. Epub 2020 Jul 1.
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.
印度的医疗器械警戒计划（MvPI）旨在确保医疗器械（包括心血管器械）的安全性。本文描述了 MvPI 监测系统的作用，该系统全面收集、整理和分析与 MD-CVD 相关的不良事件，并为中央药物标准控制组织提供补充信息，以便根据循证数据做出监管决策，减少因医疗器械不良事件给患者带来的健康负担。本文有望促进 MvPI 对 MD-CVD 不良事件的伦理报告。
