##  [Regulatory Framework for Personalized, Custom-Made Medical Devices in Australia](/white-papers/regulatory-framework-for-personalized-custom-made-medical-devices-in-australia) 

- [Medical Devices](/white-papers-categories/medical-devices)
- [Market Access](/white-papers-categories/market-access)





 ![Regulatory Framework for Personalized, Custom-Made Medical Devices in Australia]()

Custom-made devices are manufactured for sole use of a specific patient and is manufactured against a prescription issued by a qualified physician and as per specific design characteristics. Therapeutic Goods Administration (TGA) has issued a guideline on the regulation of Personalized Medical Devices (PMD), including 3D printed devices in Australia.

Earlier to publication of this Regulatory framework, Custom-made medical devices were not required to be included in the Australian Register of Therapeutic Goods (ARTG). In this guideline released on February 25, 2021, the definition of “custom-made medical devices” has been changed, due to which most of the high-risk devices previously supplied under the custom-made medical device exemption will have to be included in the ARTG.



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