In vitro diagnostic (IVD) medical devices
Links to information on in vitro diagnostic (IVD) medical devices, including HIV and nutrigenetic tests.
- Guidance for IVD sponsors - a roadmap to market
Presents an overview of the requirements for supplying an IVD under the new regulatory framework
- Regulation of IVDs: laboratory-specific information
Information for laboratories about in vitro diagnostic medical devices
- HIV testing in Australia
Tests for HIV are in vitro diagnostic medical devices (IVDs) and must be approved by the TGA and included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied in Australia. There are different types of HIV tests including:
- IVD medical devices: Definitions & links
Definitions of terms and links to other information about the regulation of IVDs
- The regulation of nutrigenetic tests in Australia
Dependant upon the claims made by the manufacturer of each test, nutrigenetic tests are considered to be therapeutic goods and therefore must comply with the requirements of the Therapeutic Goods Act 1989
- GuidanceInformation on the types HIV tests available and guidance for manufacturers and sponsors on clinical performance requirements and risk mitigation strategies for HIV tests supplied in Australia.