Mar 15, 2021
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.
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.
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.
The listed products, including both physical devices and software as a medical device (SaMD), will not be listed on the Australian Register of Therapeutic Goods (ARTG) or subject to regulatory scrutiny by the TGA.
Australia’s Therapeutics Goods Administration published a regulatory amendment and corresponding guidance on the DoC requirement for low-risk IVDs.
The impact of the COVID-19 pandemic can be seen in the postponement of the new amendments, as well as in a special discount included in this fiscal year’s fee schedule.
The impact statement explores implementing a new regulatory scheme covering 3D-printed devices.