SaMD Regulation with the Therapeutic Goods Administration (TGA)

Join ANDHealth and expert speakers from the TGA to hear an overview of the key changes in the updated SaMD regulations, and participate in a live Q&A session directly with the TGA.

This joint TGA-ANDHealth initiative supports Australian SMEs to navigate the regulatory guidelines and compliance requirements for Software as a Medical Device (SaMD).

This is an important session for all Australian digital health SMEs required to design and deliver robust clinical trials and evidence to support the safety and efficacy of their digital health products, as verified by the TGA. Come along to have your questions answered!