Australia – Australia unveils updated clinical evidence guidelines for medical devices and new private health insurance rules for prostheses

The Australian Therapeutic Goods Administration (TGA) updated several regulations, including medical devices and in vitro diagnostic (IVD) devices under Australian legislation. Changes involve clinical evidence guidelines and private health insurance for prostheses.

Updated clinical evidence guidelines for medical devices

The TGA has revised the Clinical Evidence Guidelines: Medical Devices by adding chapters for personalized medical devices (PMDs) and software as a medical device (SaMDs). In addition, the regulator has updated details on the Essential Principles (EPs) and information for total and partial joint prostheses. Specifically, additional details and some clarifications were added to give medical device and IVD manufacturers guidance on how to demonstrate compliance with the EPs. Details on the post-market surveillance of joint prostheses are also provided…