Following the US FDA and now the EU Commission’s EUDAMED, Australia’s Therapeutic Goods Administration (TGA) also has announced the introduction of the unique device identification database for medical devices marketed in Australia...

1. Australia’s TGA Introduces UDI
By: Nikita Angane
Following the US FDA and now the EU Commission’s EUDAMED, Australia’s
Therapeutic Goods Administration (TGA) also has announced the introduction of the unique
device identification database for medical devices marketed in Australia.
The announcement first came on October 6th, 2020 that the database will be established
in 2021 and has already been incorporated in the 2020-2021 budget. The rule was first proposed
and open to public comments until Feb 2019 and soon after the public consultation period
ended, TGA was seeking consultation from the industry on ways to implement the UDI system.1
TGA believes that implementation of the UDI will allow for effective tracking and tracing
of medical devices throughout their supply, procurement, distribution, and clinical uses. It will
allow for doctors to notify patients in case of a safety issue with a device and thus strengthen
Australia's post-market surveillance system. The initiation of this project is also an important
element of the Government’s response to the Senate’s inquiry on the number of women in
Australia who have had transvaginal mesh implants.1
An amendment has been issued already to the Therapeutic Goods Act of 1989 to include
the UDI schedule. As per this amendment, TGA will own and operate a database of UDI called
the ‘Australian Unique Device Identification Database’. The accredited issuing agencies have not
been announced yet and more details will be provided on the implementation once the guidance
document is available.2
The system is the first of its kind in Australia and will allow for harmonization across the
world. It will be interesting to see how the implementation plan is rolled out for the industry and
how long of a transition period will be provided. EMMA International is here to help you
throughout the UDI registration process for the US, EU, and even Australia. Call us today at
248-987-4497 or email us at info@emmainternational.com to learn more!
1 AUS Government (2021) Medical devicereforms: Establishmentof a Unique Device Identification system
retrieved on 04/05/2021 from https://www.tga.gov.au/medical-device-reforms-establishment-unique-device-
identification-system
2 AUS Government (2021) Therapeutic Goods Amendment (2020 Measures No. 2) Act 2021 retrieved on
04/05/2021 from https://www.legislation.gov.au/Details/C2021A00008/Html/Text