New TGA regulations for personalised medical devices (PMD)
1 Nov 2024
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 >>
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