Medical devices reforms: Enhancements to post-market monitoring

To enhance post-market surveillance and data analytics a new database has been developed with a sponsor compliance dashboard to facilitate a transparent, efficient, and secure way in which the TGA can notify sponsors of post-market reviews of medical devices and analyse the information that is provided. From 19 October 2020, a new Post Market Review Compliance Dashboard was published to replace the existing process of responding to a post-market review and sending associated documentation by email to the TGA.

The TGA is seeking feedback on the new dashboard and guidance through our online survey, available on the consultation hub.

Changes to the ARTG inclusion process for non-measuring, non-sterile Class I medical devices, Class 1 IVD devices, and export only IVDs and medical devices

On 20 May 2021, the Australian Register of Therapeutic Goods (ARTG) inclusion process for Class 1 in vitro diagnostic (IVD) export only devices and Class I export only medical devices was changed. This follows similar changes made on 4 December 2020 for Class 1 IVD medical devices and on 1 October 2020 for Class I medical devices.

Previously, applications for these classes of medical devices were included in the ARTG through a computer-generated decision process, with a self-declaration of compliance made by the sponsor. Some medical devices have been incorrectly included as Class I medical device or Class 1 IVDs, or applications have been found to be incomplete or inaccurate through this process.

To mitigate this the TGA made amendments to the medical device inclusion process, including publishing simplified versions of the Class I/1 Declaration of Conformity template.

More on these changes can be found at: Changes to ARTG inclusion process for non-measuring, non-sterile Class I medical devices

Reclassification of surgical mesh: Urogynaecological mesh devices

As a part of the Medical Devices Reforms, the Australian Government has strengthened the assessment of surgical mesh devices. From 1 December 2018, all new surgical mesh devices (including urogynaecological mesh devices) will be included in the Australian Register of Therapeutic Goods (ARTG) as Class III medical devices (the highest medical device classification).

From 1 December 2020 all existing Class IIb urogynaecological mesh devices were required to be up-classified and included in the ARTG as Class III medical devices. Devices were cancelled from the ARTG where the up-classification deadline was not met, noting a device may still be available via the Special Access Scheme.

More on surgical mesh reclassification can be found at: Reclassification of surgical mesh devices

More information for medical practitioners on reclassification of surgical mesh devices can be found at: Information for medical practitioners on pending up-classification of surgical mesh devices

Medical device patient information leaflets and implant cards

From 1 December 2018, manufacturers, and sponsors of all new implantable or active implantable medical devices (other than those excluded) have been required to make available to patients, patient information leaflets with the device.

From 1 December 2020, manufacturers, and sponsors of all new implantable or active implantable medical devices (other than those excluded) have been required to make available to patients, a patient implant card with the device.

A graduated transition period applies for existing medical devices. An "existing" device means one included in the ARTG because of application for inclusion was made before 1 December 2018, regardless of the date the device was included in the ARTG.

From 1 December 2019, manufacturers, and sponsors of all existing urogynaecological mesh devices have been required to make available to patients, a patient information leaflet, and a patient implant card with the device.

More on medical device patient information leaflets and implant cards can be found at: Medical device patient information leaflets and implant cards.