Australia TGA Publishes Latest Clinical Evidence Guidelines for Medical Devices

The Therapeutic Goods Administration (TGA) Australia has released the latest guidelines on clinical evidence requirements for medical devices, including in vitro diagnostic medical devices (IVDs), in June 2022. 

One of the major updates is the inclusion of personalised medical devices (PMDs) and the clinical evidence required for these devices. TGA has included further details on summary recommendations, compilation of the Clinical Evaluation Report (CER), and some points on clinical outcomes for manufacturers to focus on.  

TGA has also included information on the required clinical evidence for software and follows the recommendations outlined in these guidelines: “Software as a Medical Device (SaMD): Clinical Evaluation” by the International Medical Devices Regulators Forum (IMDRF) and “Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software”. 

More details can be found in “Clinical evidence guidelines for medical devices, Version 3.1, June 2022”:  

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