RCPA raises concerns over changes made by TGA to the regulation of self-tests for serious infectious diseases
15 February, 2021

The Royal College of Pathologists of Australasia (RCPA) raises serious concerns over changes made by the Therapeutic Goods Association (TGA) to a legal instrument which regulates certain self-testing in vitro diagnostic medical devices (IVDs) in Australia. The changes come following a consultation by the TGA to review what tests the association will allow manufacturers to provide directly to patients to perform on themselves.

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