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Assistance on post market examination and Reporting of problems associated with In-vitro Diagnostic Medical Devices under current health emergency of the COVID-19 pandemic in India
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| Author:
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, SELLA SENTHIL M, SRUTHI N, ARAVINDHANATHAN VENKATESAN, ARUN RADHAKRISHNAN, GOWTHAMARAJAN KUPPUSWAMY
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| Abstract:
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Post market examination is to safeguard end users through the close watch of IVDs offered for sale or distribution in the country. Through this action product owner must aware of the problems arises with the IVD in use and analysis the risk associated with the problem reported and take appropriate action to avoid repetition and ensure quality of the IVDs in the market . Rigorous pre-market assessment of IVDs is done by the regulatory authorities; however, there is no enough system and guidance in place for the monitoring of the post-marketing phase of IVDs in most countries including India. This article has been prepared to facilitate and strengthen the reporting of Events attributable to in-vitro diagnostic medical devices in India, harmonized with WHO, National and International best practices. This article suggested the various stakeholders follow this guidance involved in the post market phase of IVDs relates to monitoring of adverse events, reporting of adverse events, reporting timeline, examination of the complaint to determine source, and the subsequent suitable action. This article also aims to create awareness among users about the importance of reporting adverse events relating to the IVDs in India. In order to monitor the quality of the IVDs available in the country and encourage the reporting, this article also urges the central government to make online portal under respective authorities for mandatory reporting, report suspected counterfeit IVDs, for voluntary reporting serious adverse event, product quality problem, product use/medication error, or /failure that is associated with the use of an IVDs.
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| Keyword:
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Adverse event; Field safety corrective action; In-vitro Diagnostic; Post-market surveillance; Vigilance
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.146
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| Download:
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Request For Article
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