TGA Proposes Regulatory Changes for 3D-Printed, Personalized Medical Devices

Australia’s Therapeutic Goods Administration is proposing five changes to its regulatory approach for 3D-printed and personalized medical devices to reflect the rapid technological advancements over the past two decades.

“The idea that a hospital would be able to use a ‘printer’ to manufacture an implant for a particular patient’s anatomy would have been considered impossible in the not too distant past; but it is a reality today,” the TGA said, in a consultation paper.

TGA called on the medical device community, healthcare providers, patients and their representatives, and other individuals to provide feedback on the proposed regulatory changes to address any potential unintended consequence.