Australia - TGA Therapeutic Goods Amendments Act 2021

ARQon
Jul 8, 2021
2 min read

TGA has amended their Therapeutic Goods legislation and covered the prescription drug availability as well as protecting their citizen from therapeutic goods that are purposely forbidden. These amendments are done to reinforce their post-market monitoring system by improving the traceability and monitoring of the medical devices.

In Australia, there have been some recent incidents of mesh devices and breast implant failure. These incidents have brought to light the difficulty of tracing a medical device once it has been implanted in patients, posing a risk of post-market complications. New Unique Device Identification (UDI) system introduced by TGA allows them to identify and immediately recall the implanted medical devices if such incidents occur.

Current system has limitation on data collection of implanted medical devices in patients. With the new UDI system, more information can be gathered such as device model, batch number, serial number or manufacturing date. In the event of an AE incident, this information will allow for the rapid identification of a faulty unit/batch of the medical devices. Hence, the corrective actions can be taken in a very short period of time.

The data gathered from the UDI database is maintained in the Australian Medicare System. As per in the amendments, the whole or a part of the database is to be made available to specified persons, authorities or bodies; or publicly available.

This new UDI system will definitely improve the TGA’s post-market surveillance system by reducing the identification time and immediate the necessary actions.

Sources:

Therapeutic Goods Amendment (2020 Measures No. 2) Act 2021

Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020

Breast implants and anaplastic large cell lymphoma

Australian Medicare System