Regulation of IVDs: laboratory-specific information
ARTG access for registered HIV and HCV assays
Australian Register of Therapeutic Goods (ARTG) public access
Public access to the ARTG is available, and may be useful for laboratory users of commercially available Hepatitis C and Human Immunodeficiency Virus assay kits to determine which assays are currently registered for use in Australia.
- Access the Public Access to Australian Register of Therapeutic Goods (ARTG) on the TGA eBusiness Services website <https://www.ebs.tga.gov.au> and select TGA Information, then Current 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 'HC'; otherwise only partial lists will be displayed.
- To find a particular assay, you may search by using 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.
In vitro diagnostic devices - Incident Report Investigation Scheme (IRIS)
Any problems relating to the safety, quality or performance of an IVD supplied for commercial use can be reported to the TGA for investigation.
- The TGA encourages an investigation of such problems by the laboratory first, to ensure that the problem is the IVD and not a laboratory related process.
- The TGA encourages laboratories to work with sponsors (suppliers) on these issues to resolve problems.
- If a satisfactory outcome cannot be reached with the sponsor, use the Incident Report Investigation Scheme (IRIS) to report adverse events by users <http://www.tga.gov.au/docs/html/forms/iris_udir.htm>.