Quality Assurance of In-vitro Diagnostic Medical Devices (IVDs) for HIV Testing
Pre-market quality assurance of HIV IVDs
The TGA has regulatory responsibility for IVDs under the Therapeutic Goods Act 1989 and its associated regulations. The TGA has published guidance on clinical performance requirements for HIV tests.
Post-market quality assurance of HIV IVDs
All diagnostic pathology laboratories performing HIV testing do so under medical testing accreditation standards regulated by NATA and NPAAC standards and guidelines. These accreditation standards set out requirements for internal and external quality assurance practices. In addition, sponsors (i.e. suppliers) of HIV tests have mandatory obligations to report adverse events that are associated with the use or performance of the device to the TGA. The TGA’s Incident Reporting and Investigation Scheme (IRIS) manages all reports received by the TGA of adverse events or problems associated with medical devices including IVDs.
Users of HIV tests are also encouraged to report adverse events, including any malfunction of the test, to the TGA. Users can submit a report using the Users Medical Device Incident Report which can be accessed through the TGA website.
Acknowledgement of Country