Products Recalled During The Covid 19 Era: A Comparison Of Materiovigilance In India And Usa

Abstract

The healthcare system benefits from medical devices because they are instruments that can save lives. There are a number of negative effects that these devices have in addition to their therapeutic effects. To control such unfavourable impacts, a strong cohort vigilant system was required. Material caution had been developed as a result of this. Materiovigilance entails monitoring and analysing incidents that occur as a result of the use of medical technology. It not only controls AE but also brings about international harmony.In India, the post-marketing surveillance mechanism for medical devices is less strict than it is for drugs. Materiovigilance entails monitoring unfavourable outcomes brought on by medical devices after they have been marketed. Many nations, including India, have set up their own post-marketing monitoring systems in accordance with WHO guidelines. It is referred to as the Materiovigilance Programme of India in India. (MvPI).Strict monitoring of medical devices is necessary to stop the use of those that don't reach the minimum standards for quality. If necessary, manufacturers or authorised representatives can also pull certain batches of medical devices off the market. Recall is the term used to describe any action taken by a medical device's maker or supplier to remove or withdraw the device from the market or to retrieve the device from anyone to whom it has been given because the device poses a risk to health.

A thorough understanding of adverse events related to medical devices will be provided by the comparative research of the materiovigilance programmes in India and the US. Along with existing regulations, adverse event reporting, and guidance materials, the post-market vigilance framework for medical devices was examined. In order to conduct a thorough research, data was collected from various search engines and combined