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Australia Will Not Make Regulatory Changes for Personalized and 3D Printed Devices

June 4, 2018

Australia’s Therapeutic Goods Administration (TGA) released findings from a public consultation on proposed regulatory changes for personalized and 3D printed medical devices and said, based on the stakeholder feedback, it has decided not to implement regulatory changes for the devices at this time.

In its November 2017 consultation paper, the TGA noted 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.”

Stakeholders did not agree on all of the proposals, but “consistent throughout the submissions was a recognition of the need for the TGA to take action to improve the current arrangements for custom-made medical device regulation, which are too broad,” the agency said.

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