The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
- This consultation has closed. The consultation was open for feedback from 15 April 2024 to 4 June 2024 through an online survey hosted on the TGA Consultation Hub - external site.
- Through the consultation, we sought feedback on how the Instructions for Use (IFU) are provided, and whether they should be made available in more flexible formats such as electronic IFU.
- Currently, the provision of an electronic version of the IFU (eIFU) is allowed only for medical devices for professional users, where it is not practicable to provide the IFU directly on the device or the device packaging.
Outcome of the consultation
One hundred and eight (108) responses were received from stakeholders including State and Territory health entities, health professionals, heath care peak bodies, healthcare institutes, regulatory affairs consultants, consumers, and consumers peak bodies with most responses from medical device manufacturers and sponsors.
We have published a summary of the responses on the TGA Consultation Hub - external site. We have only published individual responses with the respondent's consent.
Next steps
The Government has approved the preparation of regulatory amendments to allow the provision of IFU for medical devices in more flexible formats. We are working on drafting the required changes and updates to relevant guidance documents. We expect the changes to be implemented later in 2025.
Enquiries
For any enquiries relating to this consultation or next steps, email devicesreforms@tga.gov.au