ARCHIVES
VOL. 7, ISSUE 3 (2022)
A comparative review of materiovigilance in India, US and UK
Authors
Ajay Kumar, Minakshi Garg
Abstract
A wide range of medical devices are being used to diagnose, monitor, prevent and treat a variety of diseases. In order to ensure the safety of users/patients using medical devices, robust, sustainable and scaled monitoring of adverse events associated with the medical devices is of utmost importance. Therefore, post-market surveillance is necessary to ensure the safety and performance of medical devices and to evaluate their quality too. For medical devices to be safe and of high quality, a well-structured regulatory system is essential. In 1992, five nations: The European Union, USA, Australia, Japan, and Canada formed the Global Harmonization Task Force (GHTF) with the goal of uniformizing national regulated medical devices and increasing access to safe, effective, and clinically beneficial medical technologies. Furthermore, regulated countries classify medical devices according to their associated risks. For a country like India, this is a new concept as its materiovigilance program was launched on July 6, 2015. During the review process, our aim is to provide an overview of medical device related adverse events reporting in major countries like US, EU and India. The thorough understanding of current status of materiovigilance programme of these countries along with the classification, reporting criteria, what, where, how, who and why, timeframe and tools used for reporting.
Download
Pages:74-80
How to cite this article:
Ajay Kumar, Minakshi Garg "A comparative review of materiovigilance in India, US and UK". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 7, Issue 3, 2022, Pages 74-80
Download Author Certificate
Please enter the email address corresponding to this article submission to download your certificate.

