Category Archives: regulation

Australia reviews regulation of personalized and 3D printed medical devices

Australia’s Therapeutic Goods Administration (TGA) has collated the public’s responses to proposed regulatory changes for personalized and 3D printed medical devices. Overall, the consensus has been that the proposal needs “more clarity,” and the body, therefore, is putting a halt to regulatory development for 3D printed perosnalized medical devices in favor of seeking “Further stakeholder […]

TGA hopes to redefine custom made devices with 3D printing regulations

Australia’s Therapeutic Goods Administration (TGA) has opened a new consultation seeking advice on “Proposed regulatory changes related to personalised and 3D printed medical devices.” The call to action has been launched following a concern that current regulatory frameworks are ill-equipped to “mitigate risks to patients, and to meet requirements for health care providers and manufacturers.” By […]