Abstract
MATERIOVIGILANCE PROGRAMME OF INDIA (MvPI): A STEP TOWARDS PATIENT SAFETY FOR MEDICAL DEVICES

*Pranay Kumar, V. Kalaiselvan, Ismeet Kaur, Prasad Thota and G.N. Singh

ABSTRACT

Materiovigilance is the study and follow up of incidents that might result from the use of medical devices. It enables to identify the adverse events associated with the use of medical devices. Ministry of Health & Family Welfare, Govt. of India approved and commenced Materiovigilance Programme of India (MvPI) in the country in order to monitor the safety of Medical Devices Associated Adverse Events (MDAEs) in Indian Population. The MvPI launched on 06th July 2015 at Indian pharmacopoeia Commission (IPC), Ghaziabad by the Drugs Controller general India (DCG(I)). All health care professionals, patients/consumers can reports MDAEs to Sree Chitra Tirunal Institute of medical Sciences & technology (SCTIMST), Thiruvananthapuram or National Coordination Centre (NCC) - IPC. The collected and generated safety data will help to give recommendations to Central Drugs Standard Control Organisation (CDSCO) for taking regulatory decisions on safe use of medical devices in Indian Population.

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


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