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AMA Submission to the Therapeutic Goods Administration – review of regulation for certain self-testing in-vitro diagnostic medical devices (IVDs) in Australia

22 Nov 2019

The TGA consulted on whether current prohibitions on certain self-testing in-vitro diagnostic medical devices (IVDs) should remain. The AMA believes that clinically supervised testing should remain the primary mode of testing. However, the AMA recognises the risks of consumers purchasing self-testing IVDs online from overseas and therefore supports in principle the regulation of certain self-testing IVDs for infectious diseases. In this submission, the AMA has outlined several risks that need to be mitigated before lifting the prohibition can be considered. The AMA requires further detail into the performance requirements and risk mitigation strategies of specific self-testing IVDs. The AMA opposes allowing self-testing IVDs for DTC genetic tests, and tests for serious diseases or conditions and maintains that testing should only be undertaken with a referral from a medical practitioner. Further campaigning on the risks of using self-testing IVDs not approved by the TGA should occur. 


Published: 22 Nov 2019