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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 |