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These regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002, the Therapeutic Goods (Charges) Regulations 2018 and the Therapeutic Goods Regulations 1990 to reclassify a number of kinds of medical devices to align with the European Union, modernise the regulation of personalised medical devices and devices that are software (and related programmed or programmable devices) and introduce new, tailored regimes for faecal microbiota transplant products and in vitro diagnostic medical devices that are companion diagnostics.
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