TGA hub on the Unique Device Identification system for medical devices

Post last updated on 5 July 2021.

The TGA, Australia has created a hub on the Unique Device Identification (UDI) system for medical devices.

The hub brings together information about the Australian Unique Device Identification (UDI) system under the following headings and will be updated on a regular basis to ensure the content is current and relevant:

  • Strengthening patient safety
  • Benefits to consumers and industry
  • Progress to date
  • Communications and stakeholder engagement
  • News and updates
What is the UDI system for medical devices?

It is:

  • a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard, and applied to a specific model of medical device.
  • comprised of both device information and production information.
  • applied to the device label and all levels of packaging for that device in both machine readable (such as a barcode) and human readable forms. It allows the unambiguous identification of a specific model of medical device on the market.
  • used as the ‘access key’ to information stored in a UDI database and is the data that allows the linking of device information across other systems such as registries, and in patients’ My Health Record. 

When the UDI system is fully implemented, the label of most devices will include a UDI in both a human and machine-readable form (such as a barcode). Globally harmonised, core data about those devices will be made available to the public through the Australian UDI Database (AusUDID).

Why is the TGA establishing a UDI system for medical devices?

The TGA is establishing a UDI system for medical devices in order to strengthen patient safety.

This will be achieved by the UDI :

  • allowing tracking and tracing of medical devices including those that have been implanted in patients. This will enhance the ability for doctors to notify patients quickly if there is a safety issue with a medical device.
  • Enabling other reforms designed to improve the effectiveness of pre-market assessments of medical devices and management of post-market safety-related activities.
  • Becoming the identifier used in the context of business and clinical transactions e.g. in discharge summaries, patients’ records, registries, clinical notes and records, purchase orders, invoices, inventory maintenance/ management.
What is the implementation timeframe for the UDI?

The TGA is in the early planning stages for the Australian implementation and has not yet defined the new regulations, regulatory dates or the transition approach. 

On the basis that many manufacturers supply to multiple markets and are preparing to meet the new European Union (EU) regulations, Australia does not plan to implement before the EU dates.

Where can you find further information?

On 5 July, the TGA held a webinar on the UDI system. You can view it here.

Source: TGA website