Regulating medical devices
Safe and effective treatment: Regulations
In the Australian context, the Therapeutic Goods Administration regulates what can and can’t be done in terms of medical goods and devices. The TGA also stipulates the approved materials that can be 3D-printed for medical purposes.
3D printed Medical devices are classified into classes depending on the potential harm they may cause to a patient:
Class I: Low risk
Class IIa: Low to Medium risk
Class IIb: Medium to High risk
Class III: High risk
Active implantable medical devices: High risk
You can read more about these classifications on the TGA website.
At the end of 2017 the TGA proposed regulatory changes relating to personalised and 3D printed medical devices. The government issued document has been attached at the bottom of this step if you’re interested in reading more.
- Investigate the regulating body for medical goods in your country and share your findings in the discussion
© University of Wollongong, 2018