Manufacturers of prequalified in vitro diagnostics (IVD) must submit change reports to the World Health Organization or risk having their product de-listed from the compendium of prequalified IVDs.
More field safety corrective actions (FSCAs) were issued for in vitro diagnostic (IVD) devices than any other device types in the first half of 2019, according to a report published Monday by UK-based ...
Due to COVID-19, diagnostics are in the limelight, and public and private investors are watching how the pandemic may impact the in vitro diagnostics (IVD) market in the future. As the sector receives ...
PERTH, Australia – Australia’s TGA issued final guidance on clinical evidence requirements for medical devices in response to updated regulations that have resulted in changes to evidence requirements ...
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