Consultation: legislating regulatory categories for some boundary and combination products
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 - external site. 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 - external site.
Next steps
The Government has approved the preparation of regulatory amendments that will clearly specify the therapeutic good categories for head and body lice products for humans, moisturisers and emollients, toothpastes, products generated by ozone generators, and weight loss treatment for ingestion. We are working on drafting the required changes and updates to the Understanding rules for boundary and combination products guidance. We expect the changes to be implemented later in 2025.
We have considered all feedback received in relation to the regulation of pre-filled saline flush syringes and vascular access device locking solutions, and are finalising our submission, including stakeholder feedback to the Government. Pending the outcome of the Government’s decision, we will inform stakeholders of the next steps.
Enquiries
For enquiries relating to the consultation or next steps, email devicereforms@tga.gov.au.