Skip to main content

Custom-Made Devices

Overview​

A custom-made medical device is one manufactured specifically in accordance with a written prescription for a named individual patient (or user). Custom-made devices are exempt from ARTG inclusion requirements under Schedule 4 of the MD Regulations, but this exemption is narrowly defined and does not exempt manufacturers from Essential Principles compliance or other obligations.

The Custom-Made Exemption​

A device qualifies as custom-made (and is exempt from ARTG inclusion) if:

  • It is manufactured specifically for a named patient or user
  • It is made in accordance with a written prescription from a registered health professional
  • It is not manufactured using a mass production process — the key distinction is that the device cannot be manufactured in advance in different sizes or configurations that a professional then selects from

What is NOT a custom-made device:

  • A device selected from a range of pre-manufactured sizes based on patient measurements (even if called "custom")
  • A device manufactured to a patient template using a standard manufacturing process
  • 3D-printed devices manufactured using a standard model with patient-specific dimensions — whether these qualify as custom-made depends on the specific process

Ongoing Obligations for Custom-Made Device Manufacturers​

The ARTG exemption does not remove all obligations. Manufacturers of custom-made devices must still:

  • Comply with the Essential Principles for the device
  • Maintain technical documentation for each device
  • Have an appropriate quality management system
  • Maintain records of the prescription and documentation for each device
  • Report adverse events to the TGA
  • Not supply the device to any person other than the named patient

Personalised Devices vs Custom-Made​

The TGA distinguishes between custom-made devices (a strict regulatory category) and patient-matched or personalised devices (a broader practical category that includes some manufactured devices). Patient-matched devices that do not meet the strict custom-made definition must be included in the ARTG. See the Personalised and Patient-Matched Devices page for more detail.

Official Sources​