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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Latest Updates on Materiovigilance Programme of India (MVPI)

Author: VINITHA E, JAWAHAR N, SENTHIL V
Abstract: Materiovigilance means close monitoring of any undesirable occurrences resulting from a medical device by having a system for identifying, collecting, reporting and estimating undesirable occurrences after their post marketing phase. It is to monitor safety of medical device in India. Materiovigilance Programme of India (MVPI) was approved by Ministry of Health and Family Welfare (MoHFW), Government of India and launched by Drug Controller General of India (DCGI) on 6th July 2015 at Indian Pharmacopoeia Commission (IPC), Ghaziabad. IPC acts as National Coordination Centre (NCC). Sree Chitra Tirunal Institute of Medical Science and Technology (SCTIMST) acts as National Collaboration Centre. National Health System and Resource Centre (NHSRC) acts as technical support and resource centre. Central Drug Standard Control Organization (CDSCO) acts as national regulator. The objective is to study completely about the recent updates of Materiovigilance Programme of India (MvPI). The recent updates are Medical Device Adverse Event Reporting Form (MDAE), Field Safety Corrective Action Form (FSCA), Registered Medical Device Information Sharing Portal, Personal Protective Equipment Form (PPE), Medical Device Adverse Event Reporting Tools, Medical Device Monitoring Centres, Reference Manual for Medical Device 2020 and Guidance document for Medical Device. The conclusion is that the effective reporting through the above mentioned reporting tools is required to ensure the safety of Medical Device users.
Keyword: Materiovigilance, Adverse events, Medical Device, Recent updates, Reporting tools.
DOI: https://doi.org/10.31838/ijpr/2021.13.01.019
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