In October 2017, TGA announced the implementation of patient information leaflets and patient implant cards for all implantable medical devices. This was in response to consumer concerns about the limited or absence of information provided about the medical device during surgery.

From 1 December 2018, a patient information leaflet will need to be provided by manufacturers of all new permanently implantable devices in the TGA approved format. It is intended that this summary document will be similar to the consumer medicines information leaflet given to the patient. Patient implant cards will also be required for all new urogynaecological mesh device implants.  

CHF have welcomed the announced reforms as a key component of improving informed consent for people having implanted devices and for after surgery care. Download the Consumer Guide to learn more.

Publication type: 
Publish date: 
Tuesday, June 12, 2018