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To help you determine if UDI requirements apply to your device, see: Does UDI apply to my device.
Medical devices required to meet UDI requirements
Medical devices and IVDs that you supply in Australia that must be included in the ARTG must comply with UDI requirements, unless otherwise exempt from these requirements.
The following table describes which medical device classes must meet UDI requirements. These devices must meet all UDI requirements, unless specifically exempt.
| Device classification | UDI required? |
|---|---|
| Class I nonmeasuring nonsterile | No |
| Class Im (measuring) | No |
| Class Is (supplied sterile) | Yes |
| Class IIa | Yes |
| Class IIb | Yes |
| Class III | Yes |
As a manufacturer, you may allocate and apply UDI(s) to Class I and Class Im medical devices. If you do, we recommend meeting all UDI requirements to reduce confusion for end users such as healthcare professionals.
As a sponsor, you may submit and maintain UDI records for Class I and Class Im medical devices. If you do, data must pass AusUDID validation checks.
Note: Your UDI record must be linked to at least one ARTG inclusion for its data to appear in the AusUDID and meet your compliance obligations.
In vitro diagnostic (IVD) devices required to meet UDI requirements
The following table describes which IVD classes must meet UDI requirements. These devices must meet all UDI requirements, unless specifically exempt.
| IVD classification | UDI required? |
|---|---|
| Class 1 | Partial* |
| Class 2 | Yes |
| Class 3 | Yes |
| Class 4 | Yes |
*Class 1 IVDs that are instruments or software must meet UDI requirements. These typically fall under these Global Medical Device Nomenclature Collective Terms:
instrument/analyser IVDs (GMDN Code CT943)
software IVDs (GMDN Code CT944).
As a manufacturer, you may allocate and apply UDI(s) to exempt IVDs. If you do, we recommend meeting all UDI requirements to avoid confusion for end users, such as healthcare professionals.
As a sponsor, you may submit and maintain UDI records for exempt IVDs. If you do, data must pass AusUDID validation checks.
Note: Your UDI record must be linked to at least one ARTG inclusion for its data to appear in the AusUDID and meet your compliance obligations.
Devices exempt from UDI requirements
You are not required to meet UDI requirements for:
- devices exempt from ARTG inclusion
- Class I nonmeasuring nonsterile medical devices
- Class I measuring (Im) medical devices
- in house IVDs
- custom-made medical devices
- patient-matched medical devices with a volume of 5 or less supplied each financial year
- medical devices exempt under Special Access Scheme (SAS) or Authorised Prescriber (AP) Scheme
- Surgical Loan Kits (SLKs) at kit level.
While these devices are exempt from complying with UDI requirements, you may choose to meet UDI requirements for these devices.
To submit UDI records to the AusUDID, you must link an ARTG ID and provide all mandatory data. Devices exempt from ARTG inclusion cannot be submitted to the AusUDID, as they lack an ARTG ID.
You also cannot submit UDI records for therapeutic goods that are not regulated as medical devices, as the AusUDID only permits goods regulated as a medical device.
You may still choose to meet labelling and packaging requirements for these products.
Export only devices
You do not need to meet UDI requirements for medical devices and IVDs that are:
- intended for export only from Australia
- strictly not for supply in Australia.
However, you may need to meet UDI requirements of the country you supply the device to.