New TGA regulations for personalised medical devices (PMD)

New TGA regulations for personalised medical devices (PMD)

1 Nov 2024

New TGA regulations for personalised medical devices (PMD)
 

The Therapeutic Goods Administration (TGA) has introduced new regulations for personalised medical devices (PMD) which includes patient-matched medical devices, custom and adaptable orthoses.

PMDs are not limited to orthoses and can include other materials used to create devices such as poron, otto-form, and felt padding.

What you need to know as a practitioner

From 1 July 2029 you will need to ensure that the PMDs you provide to your patients that are supplied to you by an orthotic lab or consumables supplier are registered with the TGA, included on the ARTG and are being used for their intended purpose.

Further information

APodA members can access further resources including TGA and APodA guidance resources and FAQ's relating to PMDs here >>

Not yet a member? Please click here to join us.

If you have any questions or need further clarification, please call the member support team at (03) 9416 3111.
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