FAQ's

Devices are classified into four classes: I, IIa, IIb, and III, based on their risk level.

Yes, even with CE marking or FDA approval, devices must be registered with the TGA to be marketed in Australia.

Yes, foreign manufacturers must appoint an Australian Sponsor to handle registration and compliance.

Companies without a fixed presence in Australia must appoint a domestic representative, known as an Australian Sponsor.

Sponsors are responsible for registering the device, post-market surveillance, and adverse event reporting. The name and contact information of the Australian Sponsor must be displayed on the device and its labeling.

Devices without CE marking must undergo a TGA conformity assessment, which includes reviewing safety and performance documentation.

Timelines depend on the device's classification, with higher-risk devices taking longer to assess and register.

The Australian Register of Therapeutic Goods (ARTG) is where all medical devices must be registered before they can be sold in Australia.