Regulation of IVDs: laboratory-specific information
HIV and HCV assays
Laboratory users of commercially available Hepatitis C and Human Immunodeficiency Virus assay kits can determine which assays are currently registered for use in Australia by searching the publicly accessible Australian Register of Therapeutic Goods (ARTG).
The following is a guide:
- Access the TGA eBusiness Services website and select Public TGA Information, then ARTG Devices.
- To obtain a complete list of all available assays enter either 'Hepatitis C' or 'Human Immunodeficiency Virus' into the 'Search for' field.
- Avoid using abbreviations such as 'HIV' or 'HCV', as only partial lists will be displayed.
- To find a particular assay, you may search by either the sponsor or assay name.
Users of commercially available assays should seek advice from the sponsors of these kits to determine the purpose for which the assay is registered.
The TGA has implemented a new regulatory framework for IVDs. Under the new framework, all IVDs that were supplied in Australia before the implementation date on 1 July 2010 are covered by transitional provisions and must be included in the ARTG by 30 June 2014. However, the sponsors of these IVDs can apply to have them included in the ARTG at any time prior to this date. Unless exempt, all IVDs that were introduced to the Australian market after 1 July 2010 must be included in the ARTG before they can be legally supplied. Laboratory users can determine which IVDs are approved for supply under the new regulatory framework by searching the public access version of the ARTG.
Any problems relating to the safety, quality or performance of an IVD supplied for commercial use should be reported to the TGA for investigation. This can be done via the Incident Report Investigation Scheme (IRIS).
Please note that:
- The TGA encourages the laboratory in question to carry out an investigation of the problem before reporting it. This establishes that the problem is with the IVD itself and not with a laboratory-related process.
- The TGA also encourages laboratories to work with sponsors (suppliers) on these issues to resolve problems before reporting the problem via IRIS.