Please note as at Feb 21 2021 the TGA is changing this legislative pathway to Personalised Medical Devices Changes legislation .
Custom-made medical device: the definition of a custom-made medical device will change to exclude devices that meet the new definitions of patient matched medical device or an adaptable medical device. While medical devices that meet the new definition of a custom-made medical device will continue to be exempt from inclusion in the ARTG, there will be new conditions of exemption that sponsors and manufacturers of these devices must meet from 25 February 2021.
Note: Under the new personalised medical devices framework the majority of currently supplied custom-made medical devices will now meet the definition of a patient-matched device. Patient-matched medical devices will require inclusion in the ARTG before they can be legally manufactured, imported or supplied in Australia.
Patient-matched medical devices: a patient matched medical device is a medical device that is designed and manufactured within a specified design envelope to match:
anatomical and/or physiological features of a particular individual; or a pathological condition of a particular individual.
A patient-matched device is manufactured using production processes capable of being validated and/or verified, and reproduced. Manufacturers and sponsors of devices currently supplied in Australia under the custom-made medical device exemption that will become patient-matched under the new definition will be eligible for a transition period that will extend the deadline for inclusion from 25 February 2021 to 1 November 2024.
New patient-matched devices that have not been supplied in Australia as a custom-made medical device prior to 25 February 2021 will not be eligible for the transition arrangements. See 3.2.2 For devices not supplied as custom-made before 25 February 2021 for more information.
Note: Under the new personalised medical devices framework the majority of currently supplied custom-made medical devices will now meet the definition of a patient-matched device and will require inclusion in the ARTG (by 1 November 2024 for those eligible for the transition arrangements).
Devices produced using a Medical Device Production System: a Medical Device Production System (MDPS) is a complete system supplied to a health professional or healthcare facility so that personalised medical devices can be manufactured by a health professional (or other suitably qualified person within the healthcare facility). A unique feature of MDPSs is that it is the manufacturer of the system and not the user of the system (health professional or other suitably qualified person within the healthcare facility) that is the legal manufacturer of any devices produced using the system, providing the system is used in accordance with the manufacturer’s instructions for use.
Adaptable medical devices: a mass-produced medical device intended by the manufacturer to be assembled or adapted after it is supplied, in accordance with the manufacturer’s instructions, to:
address either or both of the anatomical and physiological features of a particular individual; or
address a pathological condition of a particular individual; or
otherwise perform as intended by the manufacturer.
Adaptable medical devices will continue to need to be included in the ARTG and meet all relevant Australian regulations before they can be supplied.
Please refer to : https://www.tga.gov.au/resource/personalised-medical-devices-including-3d-printed-devices