Australia Tries Again At Tightening Personalized And 3D-Printed Device Rules
The Therapeutics Goods Administration has begun a second public consultation on how it intends to improve its rules for 3D-printed and other personalized medical devices after stakeholders called for more clarification to proposals made in 2017.
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Most of the products currently supplied under Australia’s custom-made medical device exemption will no longer be eligible for supply in this way.
Respondents to a consultation by the Therapeutic Goods Administration on how to adequately regulate personalized medical devices are against the proposed introduction of an application and approval process. But they do favor other proposals that would bolster the rules, particularly for 3D-printed products.
The strict regulatory oversight that applies to conventionally produced implants would also start applying to similarly high-risk 3D printed implants under new proposals from Australia's Therapeutic Goods Administration.