Guidance on the TGA's expectations concerning clinical performance requirements and risk mitigations for in vitro diagnostic medical devices intended to be used as self-tests for hepatitis B virus (HBV) and hepatitis C virus (HCV).
Guidance on the TGA's expectations concerning clinical performance requirements and risk mitigation for in vitro diagnostic medical devices intended to be used as self-tests for seasonal influenza.
This guidance helps sponsors and manufacturers of therapeutic goods to understand and use the Poisons Standard to determine if any restrictions apply to their product