Standards for point-of-care testing


The RACGP’s Resource guide

The RACGP’s Resource guide 

The RACGP’s Standards, 5th edition: Resource guide contains useful supplementary information that will help practices meet the Indicators in the Standards for PoCT. 

PoCT and the Australian Register of Therapeutic Goods 

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. 

The Standards for PoCT assume that your practice’s PoCT devices or systems, including but not limited to consumables, reagents, controls and software, are listed on the ARTG.