You are here

Medical devices/IVDs

14 April 2022
Agenda

The Medical Devices Action Plan Consumer Working Group (MDCWG) met via teleconference on 25 February 2022. The agenda included updates on the:

the TGA medical device reform projects; and the Medical Device Adverse Events reporting processes and reports produced for the public via the...
14 April 2022
Agenda

The Medical Devices Action Plan Consumer Working Group (MDCWG) met via teleconference on 15 December 2021. The agenda included:

an overview of the Action Plan for Medical Devices (released in 2019) and the work progressed to date by the TGA and consumers / consumer groups; the...
18 March 2022
Update to post-market review of rapid-antigen test including third party testing details
17 March 2022

Nucleic acid tests (NATs) detect a range of different gene targets within the SARS-CoV-2 genome and may be particularly vulnerable to sequence mutations, which could lead to false negative results. Therefore, it is important to assess the potential impact of emerging viral variants on the...

1 February 2022
New feature added to the consent application form on TBS portal.
1 February 2022

The TGA is reviewing all ventilators, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) devices in the Australian Register of Therapeutic Goods (ARTG) to clarify what devices incorporate sound abatement features. This action follows the identification of...

26 November 2021
New guidance on the regulation of system or procedure packs and using the special conformity assessment procedure.
26 November 2021
This guidance applies to manufacturers of medical devices that are regulated as 'system or procedure packs' and supplied using the special conformity assessment procedure regulatory pathway.
22 November 2021
Updated guidance to reflect new amendments made to the regulations.
29 October 2021
Conditions which placed limitations on the supply of a HIV self-test changed on 22 October 2021 to improve the accessibility of HIV testing.

Pages

Subscribe to Medical devices/IVDs