3D printed titanium heel

Regulating medical devices

Safe and effective treatment: Regulations

The TGA

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.

Proposed changes

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.

Conversation starter

  • Investigate the regulating body for medical goods in your country and share your findings in the discussion

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This article is from the free online course:

Bioprinting: 3D Printing Body Parts

University of Wollongong