The Therapeutic Goods Administration (TGA) has introduced medical device reforms to strengthen the regulation of medical devices in Australia to improve patient safety.
These reforms include changes to:
- personalised medical devices
- software-based medical devices
- reclassification of medical devices.
Personalised medical devices
Personalised medical devices are designed, adapted or manufactured to meet the needs of an individual patient. Examples include patient-matched devices and some devices produced using 3D printing technology.
As part of the reforms, most devices previously classified as custom-made medical devices have been reclassified as patient-matched medical devices.
These changes introduce additional regulatory requirements to support patient safety and improve oversight of personalised medical devices supplied in Australia.
Depending on how a device is manufactured and supplied, it may need to be included in the Australian Register of Therapeutic Goods (ARTG).
Software-based medical devices
Software-based medical devices are software products that have a medical purpose or perform a medical function.
Examples include:
- smartphone applications that monitor atrial fibrillation
- smartphone applications that monitor sleep apnoea
- artificial intelligence text-based products
- cardiac MRI analysers
- ECG machines.
Since 2021, many software-based medical devices are required to be included in the Australian Register of Therapeutic Goods (ARTG). Some exclusions apply. Refer to TGA guidance: Is my software regulated for more information.
Reclassification of medical devices
As part of the reforms, some medical devices have been reclassified to reflect their level of risk and ensure appropriate regulatory oversight.
This includes the reclassification of certain medical devices, including some surgical mesh products.
Resources
- Strategy 1: Improve how new devices get on the market fact sheet
- Personalised medical devices (including 3D-printed devices) (PDF 154.2 KB)
- Reclassification of medical devices fact sheet (PDF 215.7 KB)
- Software-based medical devices fact sheet (PDF 182.1 KB)