8.0 Quality assurance of in-vitro devices (IVDs) for HIV testing

Posted in: HIV

8.1 Pre-market quality assurance of HIV IVDs

The TGA has regulatory responsibility for IVDs under the Therapeutic Goods Act 1989[i] and its associated regulations. The TGA has produced a framework to guide the evaluation of HIV tests.[ii]

8.2 Post-market quality assurance of HIV IVDs

IVD manufacturers, sponsors and the TGA have responsibility for post-market monitoring of IVDs. Corrective action must be initiated by the manufacturer and sponsor of an IVD, in consultation with the TGA, as soon as practicable after becoming aware of information relating to any adverse events, malfunction or deterioration in the performance, or inadequacy in the design production and labelling of an IVD. An adverse event associated with the use of an IVD should be reported by the IVD user through the TGA’s Incident Reporting and Investigation Scheme (IRIS)[iii] There is a different form for use by medical device manufacturers or authorised representatives[iv] for mandatory reporting of adverse events associated with a medical device.

[i] Australian Government. ComLaw. Therapeutic Goods Act 1989. C2012C00848. Available at: (Cited 5 May 2015)

[ii] Therapeutic Drugs Administration (2015) Clinical Performance Requirements for and Risk Mitigation Strategies for HIV Testing (cited 05 May 2015)

[iii]   Australian Government Reporting medical device problems  (Cited 21 May 2015)

[iv] Australian Government Reporting medical device problems (Cited 21 May 2015)