Abstract

MATERIOVIGILANCE: CONCEPT AND EMERGING PERSPECTIVE FOR PATIENT’S SAFETY IN INDIA

Miyasa Moidu C. K.*

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Abstract

There has been an escalation in the number, diversity, and complexity of medical devices. Regulation of these devices has also advanced due to the requirement of better regulatory perspective induced due to elevation in the number of adverse events associated with medical devices. All over the globe, various measures are undertaken to provide better safety to the patients along with attempts to improve the standard of medical devices. Materiovigilance is the study and followup of occurrences that arise as a result from the usage of the medical equipment. It not only manages adverse events (AE) but also creates harmonization among countries. Ministry of Health & Family Welfare, Govt. of India approved and commenced Materiovigilance Programme of India (MvPI) in the country inorder to monitor the safety of Medical Devices Associated Adverse Events (MDAEs) in Indian Population. TheMvPI launched on 06th July 2015 at Indian pharmacopoeia Commission (IPC), Ghaziabad by the Drugs Controller general India (DCG(I).

Keywords: Materiovigilance Programme of India (MvPI), Medical Devices Associated Adverse Events (MDAEs), Medical Device Adverse Event Monitoring (MDAEM), Adverse Drug Reaction (ADRs).