This guidance document provides sponsors and manufacturers of COVID-19 in vitro diagnostic devices, including nucleic acid tests (NATs), rapid antigen tests (RATs), and combination tests that detect SARS-CoV-2 in combination with other viruses, detailed information regarding their ongoing obligations to ensure that their products continue to perform as intended and are safe to use.
Sponsors and manufacturers must notify the Therapeutic Goods Administration (us) of any significant changes or updates to their devices, meet all conditions of inclusions (COI), and continue to monitor device performance and safety, to ensure compliance with conformity assessment procedures and the essential principles. As part of ongoing monitoring, sponsors and manufacturers should continue to take steps to screen for and mitigate risks brought on by sub-variants of SARS-CoV-2 as they emerge. In response to signals and potential risks, we can request sponsors to provide evidence of the manufacturers’ ongoing monitoring, to demonstrate continued safety and performance.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.