Govt asks IVD kit makers to report adverse events; aims to collate info

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Govt asks IVD kit makers to report adverse events; aims to collate info - Business Standard

Quick Summary:

IVD medical devices are tests that analyse biological samples to detect disease or other conditions.

However, he added that these reports are not to be used for witch-hunting or shooting the messenger but for encouraging systemic improvements.“This is usually not used for reporting non-serious events or product complaints,” Nath said.

It was also clarified in the draft reporting format that the reporter’s identity would be held in strict confidence and protected to the fullest extent.“Programme staff is not expected to and will not disclose the reporter’s identity in response to a request from the public,” the draft proposal added.