May 6, 2020

Our most recent reports on regulatory news in Australia have focused on responses to the COVID-19 pandemic, but manufacturers with an interest in this market will want to note some unrelated developments. The Therapeutics Goods Administration (TGA) has issued new guidance documents and released information relating to public consultations on multiple subjects.

Guidance documents published on market authorization and clinical evidence requirements

In February, the TGA published a new guidance document titled Researcher considerations for medical devices – Meeting the evidence requirements for market authorisation. This is designed to help researchers working on new devices to understand the market authorization requirements for medical devices, including IVDs and software as a medical device (SaMD). The guidance summarizes the medical device life-cycle and outlines considerations during the design and development phase, pre-market application requirements, and the compilation of clinical evidence.

In March the TGA also published Clinical evidence guidelines supplement – In vitro diagnostic (IVD) medical devices. This supplemental document essentially outlines the TGA’s guidance for performance evaluation reports for IVDs in Australia, which is aligned with GHTF/IMDRF guidelines.

Public consultation submissions and invitation to comment

The TGA released results from a number of public consultations opened in early 2019 over the reclassification of various categories of medical devices. For most of the consultations listed here, proposals to align Australian classification with that of the EU Medical Devices Regulation (MDR) garnered widespread support. Proposals to up-classify spinal implantable medical devices and active implantable medical devices (AIMDs) to Class III met with a range of responses, so after further targeted consultations the TGA has settled on more nuanced changes. In the case of spinal implantable devices, motion-preserving devices will be up-classified, while implantable instrumentation such as screws and plates used in spinal fusion surgery will remain in Class IIb. Regarding AIMDs, “only long-term surgically invasive and implantable” accessories will be up-classified.

Also published were responses to a public consultation paper, Review of the regulation of certain self-testing IVDs in Australia. 26 submissions were received, of which 25 gave permission to publish and are available to review.

Finally, an invitation to comment was issued for a public consultation paper, Scope of regulated software-based products. This is based largely on reported confusion over what constitutes a medical device encountered in responses to a previous consultation over regulation of software as a medical device (SaMD).  

Related resources on Australian medical device regulation:


  • Timothy Herr