Getting a UDI

All identifiers required under the UDI framework must be issued by a TGA recognised Issuing Agency. This same Issuing Agency must issue the:

• UDI-DI
• Direct Marking DI
• Unit of Use DI
• Package DI.

Secondary DIs and Previous DIs can be issued by a different Issuing Agency.

The UDI-PI is not issued by an Issuing Agency. Instead, it is created using your device’s production information and must conform with the coding standard provided by your chosen Issuing Agency.

UDI-DIs issued by any other organisation or unrecognised Issuing Agency do not comply with Australia’s UDI requirements.

You will not be compliant if you create your own UDI-DI(s).

Manufacturer and sponsor responsibilities

In most scenarios, it is the manufacturer’s responsibility to obtain and apply a UDI to a device. This is because this process is most effectively and efficiently carried out during the manufacture process.

As a manufacturer, you are responsible for selecting a TGA recognised Issuing Agency to issue identifiers for the devices you manufacture.

As a sponsor, you should liaise with your manufacturer(s) if you have a preferred Issuing Agency.

TGA recognised UDI Issuing Agencies

We recognise the below UDI Issuing Agencies, consistent with those accepted in the United States and European Union.

United States (US) and European Union (EU) UDI compliant labels

We accept UDI Carriers that meet EU or US UDI requirements, if:

• the UDI-DI has been issued by a TGA recognised Issuing Agency, and
• the label complies with Australia’s existing regulatory and labelling requirements.

Example

A device bears a US FDA compliant UDI Carrier and meets all existing Australian regulatory and labelling requirements. The UDI-DI was issued by a TGA recognised Issuing Agency. This UDI Carrier can be used in Australia to meet UDI requirements.

You may supply devices in Australia with US or EU UDI-complaint labels, even if those devices are exempt from UDI requirements. However, we recommend submitting a UDI record to the AusUDID for these devices to help reduce confusion for end users.

If you are an Australian manufacturer exporting to the US or EU, you may use the same UDI Carrier for devices supplied in Australia. It is your responsibility to determine if there are any additional requirements you must meet for these other jurisdictions.