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.
