Changes to the regulation of personalised medical devices came into effect on 25 February 2021. Under these changes almost all medical devices previously supplied under the custom-made medical device exemption will now meet the definition of a patient-matched medical device.

For devices that meet this new definition suppliers need to either: 

• include the devices in the Australian Register of Therapeutic Goods (ARTG) before they are supplied, or 
• register patient-matched medical devices for transition to inclusion on the ARTG and apply for inclusion in the ARTG by 1 November 2024. 

Further refinements have since been made to the regulation of personalised medical devices with the introduction of the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021. 

These refinements include:

• Extending the deadline for stakeholders to register a patient-matched medical device for transition to inclusion in the ARTG by 12 months to 25 August 2022.
• Introducing an exemption for patient-matched medical devices that are supplied in very low volumes, allowing up to five (5) of a kind of patient-matched medical device to be supplied a year without an inclusion in the ARTG. 

The following web pages and guidance documents have been updated to reflect these refinements:

• The personalised medical devices landing page
• Personalised medical devices (including 3D-printed devices)
• Custom-made medical devices landing page

These refinements seek to address stakeholder concerns over their ability to meet their regulatory obligations and continue supplying personalised medical devices. Further consultation, both targeted and public, will be conducted to identify further refinements that could be made to ensure personalised medical devices are safe and fit for their intended purpose without imposing unnecessary administrative or regulatory burden.  More information about these activities will be made available as work progresses.