Australia’s TGA Introduces UDI

by Nikita Angane | Apr 12, 2021 | Labeling, Labels, Medical Devices, Regulatory, UDI

UDI labels for Australian medical devices

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 6^th, 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!

¹AUS Government (2021) Medical device reforms: Establishment of a Unique Device Identification system retrieved on 04/05/2021 from https://www.tga.gov.au/medical-device-reforms-establishment-unique-device-identification-system

²AUS 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

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.