The TGA is seeking comments on future options for the regulation of personalised and 3D printed medical devices to contribute to the development of a regulatory framework.
Comments will assist the TGA to identify issues and ensure regulation of the devices is appropriate to the level of risk.
The TGA says the increasing use of 3D printing for medical applications is raising questions globally about the adequacy of the current medical device regulatory frameworks to mitigate risks to patients, and to meet requirements for health care providers and manufacturers.
Earlier this year, the TGA hosted a well-attended workshop to consider the adequacy of the current medical devices regulatory framework for custom-made devices, especially high risk (permanently implantable) devices, enabled by 3D printing.
Details of the consultation and a paper on the proposed changes can be found online.
The consultation closes 22 December 2017 and members who wish to provide comment should direct it to AusBiotech Deputy CEO, Lorraine Chiroiu (lchiroiu@ausbiotech.org / 03 9828 1400) by 17 December 2017.