Australia Will Develop UDI System for Medical Devices Following New Regulatory Amendment

Australia’s Therapeutic Goods Administration (TGA) has issued the Therapeutic Goods Amendment (2020 Measures No. 2) Act 2021, which amends the Therapeutic Goods Act 1989. Schedule 2 of the amendment establishes provisions for the creation of a unique device identification (UDI) system to be used for medical devices. It also stipulates that the TGA will establish and maintain its own UDI database, known as the Australian Unique Device Identification Database. Official guidance is expected to provide further details on the implementation of UDI requirements in the near future.

Amendment provides language to restrict international commerce in medical devices

The amendment also includes provisions that may be used to prohibit the import, export, manufacture, and/or supply in Australia of therapeutic goods (including medical devices), in line with international agreements to which Australia is a party.

More provisions impacting therapeutic goods available for review

The ten sections of the amendment deal with a number of issues, many of them pertaining to pharmaceutical or to therapeutic goods in general. The current consolidated copy of the Therapeutic Goods Act 1989, in which the latest amendment is incorporated, may be found here.

Related resources on Australian medical device regulation:

• Australian TGA medical device registration consulting
• Medical device vigilance reporting in Australia
• Australian TGA Sponsor in-country representation