About this consultation
In October 2022, the TGA undertook a public consultation on the draft guidance for Boundary and combination products - medicines, medical devices, and biologicals.’ Feedback received on the consultation indicated the need for additional clarity and transparency on the regulatory category of some boundary and combination products.
Therefore, in this consultation, we are seeking feedback on:
- Whether legislating some products where possible to formally declare their regulatory category and/or classification will provide additional clarity for stakeholders, and
- Whether a transitional period of five years is sufficient for sponsors of affected ARTG entries.
For more details, read the consultation paper available on the TGA Consultation hub and provide your feedback by answering the survey questions. The consultation will be open for feedback from Monday 24 June 2024 to Tuesday 6 August 2024.
Next steps
We will review the feedback received and determine whether to proceed with legislative changes accordingly. The example list on boundary and combination products will also be updated if required.
Enquiries
For enquiries relating to the consultation or next steps, email devicereforms@tga.gov.au.