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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PageLearn how Australia’s UDI framework aligns globally and fits within the Essential Principles.
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PageUnderstand how to get a UDI and which UDIs from other jurisdictions 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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PageUnderstand how UDI requirements may impact existing TGA processes.
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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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PageLearn about your obligations in meeting UDI requirements in Australia.
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PageLearn about UDI requirements for individual device types, such as implantable devices, software, and surgical loan kits.
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PageLearn about each type of identifier required under the Australian UDI framework.
Contact us
Email: UDI@health.gov.au
Product types