Only a few days remain for completion of the online survey made available by the TGA, which closes on 13 December 2021. The TGA website explains:
Following the Senate Inquiry into the Number of women in Australia who have had transvaginal mesh implants and related matters which highlighted that the number, range, and complexity of medical devices will increase over time, the Australian Government supported working closely with healthcare facilities and state and territory health departments to find ways to increase rapid information sharing about medical device safety and effectiveness. An Action Plan for Medical Devices: Improving Australia’s medical device regulatory framework, 2019 endorsed the TGA exploring whether it should be mandatory for healthcare facilities to report adverse events/safety problems with medical devices to the TGA.
The Action Plan document is available here.
The Discussion Paper is available here.
The Online Survey links are on this page.
With thanks to Bruce Baer Arnold for noting this consultation on his blog Barnold Law.
[BillMaddensWordpress #1919]