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.
The agency is inviting comments on the following proposed changes:
TGA called on stakerholders for feedback on the proposed regulatory changes to address any potential unintended consequence.
Read the consultation paper here: www.fdanews.com/11-10-17-Consultation.pdf.