Jun 29, 2022

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.

IVD makers should also review the document entitled Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices, which provides more specific IVD guidance.

Private health insurance rule changes for prostheses benefits

The Australia Department of Health has published the Private Health Insurance (Prostheses) Rules (No. 2) 2022, which repeals and replaces the Private Health Insurance (Prostheses) Rules (No.1) 2022. The new Prostheses Rules take effect on July 1, 2022.

The Prostheses Rules primarily update the Prostheses List and set out the minimum and maximum (if applicable) benefit payable. Specifically, in this edition, a number of Prostheses List billing codes were added, changed or deleted, as a result of sponsor applications. Additionally, about half of the billing codes in Part A of the Prostheses List have reduced benefits based on the first phase of reductions scheduled for July 2022. Further reductions are scheduled for 2023 and 2024.

Further details are provided in the Circular PHI 34/22, and the Private Health Insurance (Prostheses) Rules (No. 2) 2022 and its explanatory statement.

Emergo by UL advisors will add further details on TGA guidance as the regulator releases them.

Learn more about medical device regulations in Australia:



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    Kathryn Burke