TGA Updates Guidance on COVID-19 Rapid Antigen Test Performance and Risk Mitigation
The TGA has updated its guidance on performance requirements and risk mitigation for COVID-19 rapid antigen tests, covering analytical and clinical evidence, self-test usability, IFU requirements, software, COR approvals and post-market monitoring.
Important news for COVID-19 test manufacturers: change in the classification of rapid antigen tests
With the entry into force of the IVDR, rapid antigen tests for COVID-19 are now classified as Class D devices, requiring assessment by a Notified Body.