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The way that custom-made medical devices are regulated is changing.


A new framework for regulating personalised medical devices will commence on 25 February 2021. Under the new framework most custom-made medical devices that are currently supplied in Australia will no longer be exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG).  Any devices that will continue to be exempt will need to meet new requirements.

If you manufacture, import or supply a custom-made medical device, you will be impacted by the changes and should review the guidance available on the Therapeutic Goods Administration (TGA) website.

There is a transition period available if you are currently manufacturing or supplying custom-made medical devices, you will now need to seek TGA approval and include your devices in the ARTG. If you access the transition period, you will have until 1 November 2024 to submit an application to the TGA for inclusion in the ARTG. Accessing the transition period is a two-step process:

  1. You must notify the TGA that you are a manufacturer or supplier of custom-made medical devices before 25 February 2021; and
  2. You must then apply for the transition period before 25 August 2021.

Other changes introduced by the new framework include:

  • New definitions for categories of personalised medical devices;
  • The new concept of a Medical Device Production System (MDPS); and
  • New classification rules for devices that record patient images, and anatomical models.

More information about the changes is available on the TGA website: https://www.tga.gov.au/resource/personalised-medical-devices-including-3d-printed-devices

The Pedorthic Association of Australia will be partnering with the TGA in the coming months to provide more information to members, including a dedicated educational webinar. For now, you are encouraged to make sure you have notified the TGA if you are manufacturing, importing or otherwise supplying custom-made devices to ensure you will be eligible for the transition period if you need to access it.

Kind regards,
The PAA Board


PAA – Pedorthic Association Australia