Category Archives: TGA

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 […]

China FDA calls for professional guidance on 3D printed medical devices

As the self-made manufacturing capitol of the world, China is a country to look to for 3D printing’s ascension into the supply chain. Though a recent report stated “It is still too early to conclude that the mass production era has been replaced by the mass customisation era,” the State has made formal efforts to increase […]

Australian Dental Industry Association to help redefine medical 3D printing

The Australian Dental Industry Association (ADIA) has announced that it will be supporting Australia’s Therapeutic Goods Administration (TGA) to make regulatory changes in legislation for 3D printing in medicine. The announcement comes just one month after the TGA’s initial proposal, and affirms a notion that the changes will help make customized healthcare safer for everyone. Balancing […]

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 […]