New guidance on regulatory changes for custom-made medical devices


New guidance on personalised medical devices (PMD), including 3D printed devices, has been released by the TGA. New regulatory requirements will apply under the framework from 25 February 2021.

The new rules are applicable to manufacturers, sponsors or suppliers of devices that are, or can be, personalised to address the particular needs of an individual. Actions to comply with the amended regulations will depend on whether or not the device is currently included in the Australian Register of Therapeutic Goods (ARTG).

Custom-made medical devices are currently exempt from being included in the ARTG. New definitions are being introduced will affect the majority of devices under this pathway; the new regulations will impact differently depending on which of the PMD definitions are met.

This includes:

  • custom-made medical devices;
  • patient-matched medical devices;
  • medical device production systems;
  • diagnostic images; and,
  • anatomical models.

The concept of a Medical Device Production System (MDPS) will be introduced, together with a framework for regulating these systems, to enable healthcare providers to produce PMD for treating their patients without the need for manufacturing certification.

The new guidance document includes a decision tree to help manufacturers and sponsors determine which new definition the PMD will be regulated under; case study examples, checklists to action, and a statement template.

AusBiotech’s AusMedtech Regulatory Affairs Advisory Group fed into the framework consultation through its participation the TGA’s RegTech Forum. Alongside consulting with industry on the new framework, the TGA also consulted with global regulators.

Download the guidance document on the TGA’s website here.