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AUSTRALIA: Information for Medical Practitioners on Up-Classification of Surgical Mesh Devices – March 2022

AUSTRALIA: Information for Medical Practitioners on Up-Classification of Surgical Mesh Devices – March 2022

  • 2022-03-25 10:23:24

In December 2018, TGA has announced that there will be an adjustment of Surgical Mesh Devices to transform from medium risk (Class IIb) to high-risk devices (Class III), in order to meet the highest levels of safety, quality and clinical performance.
Sponsors were given three years to comply with the changes, and from 1 December 2021 onwards TGA has already commenced on cancelling surgical mesh devices in the ARTG as Class IIb entries, who do not have obtained an appropriate conformity assessment certificate for Class III devices prior to the set deadline, or within six months of the conformity assessment certificate for the Class III device being issued.
TGA has listed out 3 different tables, categorising meshes that are eligible for transition, approved surgical mesh devices, and existing Class III surgical mesh devices. This is to inform medical practitioners and hospitals of potential supply disruption of some surgical mesh devices from 1st December 2021, and to provide alternative sources of supply.

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AUSTRALIA: Reclassification of Critical Medical Devices – December, 2021

AUSTRALIA: Reclassification of Critical Medical Devices – December, 2021

  • 2021-12-27 02:04:41

TGA regulates all medical devices that are for introduction into the body as Class IIa (low-medium risk) or Class IIb (medium-high risk) devices. Transitional arrangements are in place to ensure that manufacturers can continue to supply their previously registered devices while they apply for them to be included in the ARTG in accordance with the new classification.

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AUSTRALIA: Changes to ARTG's Inclusion Process for Non-Measuring, Non-Sterile Class I Medical Devices – July, 2021

AUSTRALIA: Changes to ARTG's Inclusion Process for Non-Measuring, Non-Sterile Class I Medical Devices – July, 2021

  • 2021-08-01 14:48:08

TGA's inclusion process for Class I in vitro diagnostic (IVD) medical devices in the Australian Register of Therapeutic Goods (ARTG) changed on 4 December 2020. This follows similar changes made on October 1, 2020, for Class I non-measuring, non-sterile medical devices. This article outlines the key changes about including Class I medical devices and Class 1 IVD medical devices in the ARTG.

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