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We are implementing new rules that require medical devices to be identified through a Unique Device Identifier (UDI) that is printed on device labels, the device’s packaging and, for applicable devices, directly marked on the device itself.
UDI can strengthen patient safety through:
- providing consumers with better information on medical devices and their characteristics
- helping identify medical device problems for specific devices sooner
- faster and more effective recalls
- offering a way for consumers to record in their own records (MyHealth record), information about the device.
In the future, you will be able to look up any device you use or are getting implanted, on the Australian UDI Database (AusUDID).
AusUDID doesn't store patient information.
UDI overview
UDIs are like barcodes for products. It combines numbers, symbols and letters that identify the product. The UDI will be unique to every model of device. It will be issued by a TGA recognised Issuing Agency to ensure that it is globally consistent and unique for each type of medical device.
All high risk and implantable devices will include the UDI on the device’s label and packaging. This includes medical devices manufactured overseas and supplied in Australia.
Devices with a UDI
Once the UDI is legally required, most medical devices and in vitro diagnostic (IVD) devices supplied in Australia will have one.
High risk, implanted, and diagnostic test medical devices will need to comply with the UDI regulations.
Low risk medical devices will not need to comply with the UDI regulations. They will continue to be identified by existing methods.
Medical devices with higher risk classifications will need to comply with the UDI regulations:
Types of devices | Device classification and risk | UDI required |
|---|---|---|
| Class I (low risk) | No |
| Class Im (low-medium risk) | No |
| Class Is (low-medium risk) | Yes |
| Class IIa (low-medium risk) | Yes |
| Class IIb (medium-high risk) | Yes |
| Class III (high risk) | Yes |
In vitro diagnostic (IVD) devices with the following classifications will need to comply with the UDI regulations:
Types of devices | Device classification and risk | UDI required |
|---|---|---|
| Class 1 (no public health risk or low personal risk) | Selected devices |
| Class 2 (low public health risk or moderate personal risk) | Yes |
| Class 3 (moderate public health risk or high personal risk) | Yes |
| Class 4 (high public health risk) | Yes |
More information including detailed definitions of in vitro diagnostic devices is available at Overview of medical devices and IVD regulation.
UDI labels
An example of a UDI label incorporated into existing labelling.
A UDI will be printed on the device labelling or packaging in a format that allows it to be read by humans and systems.
There are no restrictions on the form for the machine-readable portion of a UDI as some forms may be more appropriate for specific settings, for example one-dimensional barcodes may be more suited for supply chain use. This means that you might see a UDI in the multiple forms such as barcodes or QR codes.
UDI for adverse events and recalls
We will require the UDI to be included in official reporting from sponsors and manufacturers of medical devices, for example in:
- recall procedures
- voluntary recalls
- adverse event reports.
This will allow for greater accuracy in reporting and faster aggregation of related reports, enabling us, sponsors and other healthcare organisations to:
- more rapidly collate and analyse data
- better identify device concerns sooner
- allow more targeted and rapid safety alerts, recalls and safety corrective actions on specific devices.
To find information about a health product's recall see Product recalls.
UDI for Patient Implant Cards (PICs)
When you have a medical device implanted in a hospital or health care setting in Australia, you should be provided with a Patient Implant Card (PIC). The PIC contains important information about your medical implant. Once UDI is implemented, the UDI will also be included on your PIC.
Using the UDI on your PIC, you can search the Australian UDI Database (AusUDID) to find more details about the device. The information in the AusUDID is available free of charge.
Once the UDI is included on a Patient Implant Card, it will be on the card in both a machine readable and human readable format, as in the image below.
Australian UDI database (AusUDID)
Our Australian Unique Device Identification Database (AusUDID) will store data about medical devices used in Australia, including the UDI of each medical device. The AusUDID will allow you to search, view, and download UDI information.
AusUDID doesn't store patient information
The AusUDID will only hold data about the medical device such as its name, size, clinical use characteristics and any related Patient Information Leaflets (PILs).
Accessing AusUDID
As the UDI changes to the Therapeutic Goods (Medical Devices) Regulations 2002 are still being defined, we are unable to provide an exact timeframe of when UDI will commence.
Our website will have further information once the AusUDID is available.
Finding devices on AusUDID
The AusUDID will allow you to search for device information.
Here is how to find device information:
- searching by the UDI found on the label or packaging
- searching by keyword (such as brand name, or manufacturer name)
- scanning the barcode on the device label or packaging using a mobile phone or a similar device with a camera or barcode scanning capabilities.
If you are unable to scan the barcode, you can also manually enter the numbers and alphabetic letters which you will find under the barcode.
More information
Five questions to ask your health professional before you get a medical implant
Overview of medical devices and IVD regulation
About Australian recall actions
Patient information materials for medical implants: a fact sheet for consumers
Contact us
UDI@health.gov.au
Australia: 02 6289 8557
International: +612 6289 8557