Changes to the regulation of custom-made medical devices

23 March 2021

In February 2021, the Therapeutic Goods Administration (TGA) published information about changes to the regulation of custom-made medical devices. This new framework changes how many custom made medical devices are regulated and will affect anyone who manufactures, imports or supplies personalised medical devices.

The new framework introduces new definitions for 'custom made' 'patient-matched' and 'adaptable' medical devices.

What does this mean for members of the AHTA?

The TGA have advised that there will be a transition period until 25 August 2021.

The AHTA is partnering with the Australian Physiotherapy Association (APA) and Occupational Therapy Australia (OTA) to bring representatives of these stakeholder groups to form a steering group. The steering group will be formed and chaired by Dan Miles, Deputy General Manager, Policy and Government Relations, APA. Its purpose will be to collaborate with the TGA to ascertain how members will be impacted, before the transition period ends on 25 August 2021.  The AHTA invites individuals to express interest to join this steering group by contacting Wendy Rowland, CEO via email

The AHTA will provide regular updates through eNEWS and this website page.

If you would like to read more visit the TGA website.

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