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Home » TGA Proposes Overhaul for Software as Medical Device, Personalized Devices

TGA Proposes Overhaul for Software as Medical Device, Personalized Devices

February 21, 2019

Australia’s Therapeutic Goods Administration issued two new guidances, one proposing a regulatory framework for personalized medical devices and the other on the regulation of software, including software as a medical device (SaMD).

The proposed regulatory changes for personalized devices include new definitions for such devices and alterations to the requirements for supplying custom-made devices so that sponsors must provide additional information to the TGA and patients and allow the agency to inspect manufacturing sites.

The agency would also introduce a framework for regulating a medical device production system to allow healthcare providers to produce lower-risk personalized devices for patients without the need for manufacturing certification.

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