Australia – Patient implant cards and consumer device information leaflets

From 1 December 2018, manufacturers of all new permanently implantable devices (other than those exempted) will need to provide patient implant cards and have a consumer device information leaflet, as part of new consumer information requirements.

Information requirements

In consultation with the medical devices industry, the TGA has developed guidance which outlines the information requirements for patient implant cards and consumer device information leaflets. The guidance also includes recommendations for card and leaflet design to maximise the benefit of these information materials for consumers…