Australia TGA Regulatory Approval Process for Medical Devices
The chart shown illustrates the TGA approval process in Australia and is available for download in PDF format. Also includes a timeline of expected approval.
The Australian TGA medical device approval process explained
To obtain access to the Australian market, medical device and IVD manufacturers will need to include their product in the Australian Register of Therapeutic Goods (ARTG), regulated by the Therapeutic Goods Administration (TGA). If you have already acquired the European CE Marking, the TGA approval process will be easier since the Australia recognizes CE Marking.
Determine classification using Schedule 2 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002. If your device has European CE Marking, the classification will likely be the same. A CE Marking certificate from a Notified Body is generally accepted by the Therapeutic Goods Administration (TGA) as part of your registration. TGA also accepts MDSAP certificates with acceptable overseas marketing approval (i.e., Health Canada MDL, Japan MHLW/PMDA PMC or PMA, US FDA 510(k) or US FDA de novo); or Japan MHLW/PMDA QMS certification with Japan MHLW/PMDA PMC or PMA.
If you have no local presence in Australia, appoint an Australian TGA Sponsor. The Sponsor facilitates your device registration, acts as the liaison between the manufacturer and the TGA, and the Sponsor’s name must appear on your device and labeling.
Have current Technical File or Design Dossier and Australian Declaration of Conformity ready for submission.
For all devices except Class I Non-sterile, non-measuring, Sponsor submits Manufacturer’s Evidence (e.g., CE Marking certificate) in TGA Business Services (TBS) system for TGA’s review and acceptance.
Sponsor submits Medical Device Application in TBS System. The Application includes Intended Purpose statement, classification and Global Medical Device Nomenclature (GMDN) code. Pay application fee.
TGA will review sections of your Design Dossier as part of a Level 2 application audit. A Level 2 application audit is required for all Class III devices, but only a small percentage of Class IIb devices.
The TGA will approve or reject your application. If approved by TGA, an Australian Register of Therapeutic Goods (ARTG) listing number will be issued (ARTG Certificate of Inclusion) and your listing will be included in the ARTG database on the TGA website.
You may now begin marketing your device in Australia. Registrations do not expire as long as you do not make changes to the device that would invalidate the ARTG listing, a current CE Marking certificate (if applicable) is on file with the TGA, and the annual ARTG listing fee is paid.
IMPORTANT NOTE: This chart demonstrates the route to compliance in Australia for devices that already have CE Marking and which do not include animal tissue, human blood/plasma derivaives, or medicinal components.
Chart updated: 05/20/2019