Point of care testing standard
In Australia, PoCT devices and systems are categorised as in-vitro diagnostic medical devices (IVDs) and are therefore regulated as a subset of medical devices by the Therapeutic Goods Administration.
The Australian Register of Therapeutic Goods (ARTG) lists therapeutic goods that can be legally imported into Australia, or supplied for use in Australia, or exported from Australia.
Unless a specific exemption has been granted, it is a criminal offence under the Therapeutic Goods Act 1989 to import into, supply in or export from Australia a medical device that is not listed on the ARTG.
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