This consultation closed on 20 August 2024.
We invited stakeholders to provide feedback on whether legislating some boundary and combination products to formally declare their regulatory category or classification would provide additional clarity for stakeholders.
The consultation was open for feedback from 24 June 2024 to 20 August 2024 through an online survey hosted on the TGA Consultation Hub.
Outcome of this consultation
We received thirty-four (34) responses from a range of stakeholders such as medical device manufacturers, sponsors, medical device industry peak bodies, state and territory health departments, regulatory affairs consultants, health professionals and consumers.
We published a summary of responses on the TGA Consultation Hub. We also published individual responses where the respondent agreed to publish.
After the public consultation, we also held targeted workshops to further discuss topics in this consultation paper. We also published a summary of feedback received through the workshops on the TGA Consultation Hub.
Next steps
We have reviewed the feedback from the consultation and targeted workshops. We are considering the feedback and may undertake further targeted consultations to finalise any policy positions before seeking Government consideration. We will inform stakeholders of the outcomes of the Government’s consideration including any changes to the regulatory categories or risk classification of these products. We will also update the relevant guidance document for the regulation of boundary and combination products if the Government decides to make any changes.
Enquiries
For enquiries relating to the consultation or next steps, email devicereforms@tga.gov.au.