The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Project overview
The Australian Government has strengthened the assessment of surgical mesh devices as part of the Reforms.
From 1 December 2018, all new applications for surgical mesh devices (including urogynaecological mesh devices) seeking approval from the TGA were required to meet the higher evidentiary requirements of a Class III medical device.
A transition period applied for surgical mesh devices already included in the Australian Register of Therapeutic Goods (ARTG):
- Urogynaecological mesh devices, a two-year transition period applied. This means sponsors needed to lodge a reclassification application by no later than 1 December 2020.
- Any other type of surgical mesh, a three-year transition period applied. This means sponsors needed to lodge a reclassification application by no later than December 2021.
Consultations
| Consultation | Status |
|---|---|
| Alignment with European medical device regulatory framework - Up-classification of surgical mesh & patient implant cards | Consultation closed 25 August 2017 |