TGA Publishes Guidance Documents for Reclassified Medical Devices

Australia’s Therapeutic Goods Administration (TGA) published several guidance documents dealing with the reclassification of medical devices and related transitional arrangements beginning on November 25, 2021.

Guidance documents address postponed reclassification of given medical device categories

This reclassification process is based on the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 and was originally scheduled to take effect on August 25, 2020. The TGA announced a delay to implementation of this step as a result of difficulties relating to the COVID-19 pandemic.

The newly published guidance documents cover three of the six categories subject to reclassification. All are being up-classified to reflect reevaluation of their risk levels, with the exception of active implantable medical devices (AIMDs), which are being eliminated as a separate device class and merged with Class III medical devices. The guidance documents address the following categories, with their new classifications provided alongside:

• Active medical devices for therapy with a diagnostic function - Class III
• Medical devices that administer medicines or biologicals by inhalation - Class IIa or Class IIb, as applicable
• Active implantable medical devices (AIMDs) - Class III

Deadlines and transitional arrangements for reclassified Australian medical devices

The guidance documents discuss the required actions and associated deadlines for reclassified devices in these categories. For devices included in the Australian Register of Therapeutic Goods (ARTG) prior to November 25, 2021, manufacturers or Sponsors must submit an online form before May 25, 2022 to notify the TGA that the device will need to be reclassified. They must subsequently file an application for the new classification before November 1, 2024.

Additionally, for AIMDs listed on the Prostheses List, an application to amend the Prostheses List billing code will be needed once the new ARTG listing number is issued, to avoid delays and inaccuracies in benefits paid by private health insurers.

More resources on Australian medical device regulation from Emergo by UL:

• Australian TGA medical device registration consulting
• Medical device vigilance reporting in Australia
• Australian TGA Sponsor in-country representation