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Medical devices regulation basics

Related information

10 November 2021

How medical devices are included in the ARTG

The Australian Register of Therapeutic Goods (ARTG) is the central database of therapeutic goods that can be legally supplied in or exported from Australia. Medical devices included in the ARTG have sponsors, who take legal responsibility for their supply in or from Australia.

The sponsors of medical devices are responsible for ensuring they are included in the ARTG, unless exempt or excluded, before supplying them. For more information on what a medical device sponsor needs to do, please refer to the Australian Regulatory Guidelines for Medical Devices (ARGMD).

To do business with the TGA, please establish a TGA eBusiness Services account.

Once a sponsor has all the necessary information for the medical device/s they want to supply, they can lodge an application with the TGA via TGA eBusiness Services.

Useful information for Australian medical device sponsors

Stay informed about medical device regulations

There are several ways to get information about changes to Australia's medical device regulations:

Regulatory consultants and industry associations

The TGA does not provide the details of consultants who specialise in regulatory affairs and assistance with meeting the therapeutic goods regulations. Sponsors and manufacturers of medical devices may find it helpful to contact a relevant industry association for this kind of information.

Please note: providing details of these associations is not an endorsement of them by the Therapeutic Goods Administration.

Providing feedback to the TGA

Use the following links to: