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.
