The UDI system supports the identification of medical devices and other medical device reforms. It is designed to improve the effectiveness of the regulatory framework, including management of post-market safety-related activities such as recalls.
The UDI system can support the tracking and tracing of medical devices.
If UDI is widely adopted, it can enable:
- faster identification of devices
- improved data quality
- reduction in data errors and inconsistencies
- support for anti-counterfeiting measures
- consistency in data capture and greater automation.
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PageThe TGA has a streamlined Consent to Supply process for Unique Device Identification related Essential Principles.
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PageLearn how Australia’s UDI framework aligns globally and fits within the Essential Principles.
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PageLearn how to obtain a UDI and which internationally issued UDIs are accepted in Australia.
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PageLearn which changes to a device are considered a UDI Trigger, and how to manage these changes.
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PageUnderstand and apply the UDI labelling and packaging requirements to your medical devices.
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PageLearn how UDI requirements relate to other TGA processes and regulatory activities.
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PageLearn about the Australian Unique Device Identification Database (AusUDID) and how to use the database to comply with UDI requirements.
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PageUnderstand the responsibilities of sponsors and manufacturers in meeting UDI requirements.
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PageLearn about UDI requirements for specific device types, including implantable medical devices, Software as a Medical Device (SaMD), and surgical loan kits.
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PageLearn about each type of identifier required under the Australian UDI framework.
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User guideLearn how to complete an application for consent to import, supply or export medical devices that do not meet UDI-related Essential Principles.
Contact us
Email: UDI@health.gov.au
Product types