AMA submission to TGA propos​ed regulatory changes to personalised and 3D printed medical devices​

The AMA supports the proposals outlined in the TGA’s consultation paper for changing the regulatory framework underpinning personalised and 3D medical devices. The AMA considers these are sensible and reasonable changes which recognise the increasing use of 3D printing for high risk implantable medical devices, and which are required to mitigate the risks to patients arising from these and other personalised devices.