The Drugs Technical Advisory Board (DTAB) has agreed with a proposal to amend the Medical Devices Rules (MDR), 2017, to include definition of reportable events related to medical devices, in a move to ...
The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final ...
The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the ...
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