Instructions for Use Regulatory Amendments
| Issuing Body | Therapeutic Goods Administration (TGA) |
| Opening Date | 12/06/2026 |
| Closing Date | 26/06/2026 |
| Status | Closed |
[EXTENDED – Feedback now due COB Thursday, 25 June]
The TGA is proposing regulatory amendments to allow Instructions for Use (IFUs) for medical devices to be provided in more flexible formats. These amendments are scheduled to be considered by the Executive Council at its August meeting, with implementation anticipated between August and September 2026. The eIFU guidance (attached) is being updated to reflect the proposed amendments.
If you have any comments on the draft guidance, please comment them below or email lwaheed@mtaa.org.au by COB Thursday, 25 June.
The guidance needs to clarify if there are separate requirements for use of electronic IFUs for HCPs verses layman user. Because it is not differentiated / called out in the guidance, it reads like the legislation is requiring paper IFU for “all single use devices which cannot be used for its intended purpose without instructions” (page 4 and other multiple references). This would be contradictory to the existing practise and international aligned practice of providing only e-IFU for all devices use by HCPs are allowed.
I agree, Mahesh. There seems to be a sentence missing clarifying that this applies for users and not for HCPs.
I know we touched on this in the RAC Meeting yesterday, but a blanket ban on all medical devices that may be used by consumers also doesn’t make sense.
The urinary catheter example is a good one to explore – these can be used in healthcare facilities by HCPs and also at home by consumers. When used at home it is standard practice for a HCP to train the patient on insertion, care and removal / changeover. These are also often used by consumers for extended periods of time for long-term or chronic diseases.
Other drainage devices used in other body cavities would be in a similar situation.
Do we really agree that devices like these must have a hard copy IFU provided.
There really are too many devices used by consumers to be able to list those that are okay to be provided only with eIFUs – it has to come down to risk management conducted by the manufacturer.
If this is going to be all devices used by consumers, there has to be a transition period to allow those products already using eIFUs only to transition back to hard copy IFUs. Without a transition period, those devices relying only on eIFUs will immediately be non-compliant.
I agree with your position Hugh. My recollection is that the TGA was looking to formalise the use eIFU for consumer devices to be ahead of the rest of the world. The wording in this document is a step backwards for all devices and against what they proposed in the consultation.
The key points on page one seem to be expanding the use of eIFU’s for all devices but changes are necessary as that position is contradicted by the rest of the document. Specific changes I’ve identified include:
Page 3: Information that must be provided with a medical device
Manufacturers must make the IFU of a medical device available to the user of the device by:
• being provided with the device (add OR)
• being made available electronically in a way that is readily accessible by potential users of the device.
Page 4:
• the device is single-use and cannot be used for its intended purpose without instructions (Clarify that this is for consumers only when they have not been instructed on how to use the device by a HCP)
Page 6: Products that must continue to be supplied with a hard copy
• a single-use device that cannot be used safely for its intended purpose without instructions. (Clarify that this is for consumers only when they have not been instructed on how to use the device by a HCP)
Page 7: Products that are recommended to be supplied with a paper IFU
Change “Manufacturers should continue to provide paper IFUs for devices used” to “Based on a risk assessment of the device, it may be more appropriate to provide paper IFU’s for devices used”
I concur with the position outlined by Mahesh, Hugh, and Kellie.
The only addition I would suggest is to incorporate the point raised by Hugh during our meeting—specifically, referencing the regulatory impact statement + the draft regulation (with any proposed amendments clearly marked as redline).
Reviewing the regulatory impact statement alongside the draft regulation would also help ensure we are not only interpreting the wording, but also understanding the underlying intent, assumptions, and expected real‑world impact of the proposed changes.