NOTIFICATION FORM: Transition arrangements for custom-made medical devices

Overview

This form should be used by manufacturers and sponsors of medical devices that are eligible for the transition period for custom-made medical devices that will be patient-matched medical devices from 25 February 2021. Devices are eligible for transition if:

• the device has been supplied under the custom-made medical device exemption before 25 February 2021;
• a notification of the manufacture or import of that kind of custom-made medical device has been submitted to the TGA; and
• the device meets the definition of a patient-matched medical device under the new regulatory framework for personalised medical devices commencing on 25 February 2021.

Please note: This form is being hosted on a consultation platform, however it is not a consultation and none of the information that you provide using the form will be published.

Details of the changes

Under the Australian regulatory framework for medical devices, 'custom-made' medical devices are exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG). 

From 25 February 2021, new definitions for medical devices that are personalised to suit an individual patient or health professional will commence. The majority of the medical devices currently supplied under the custom-made exemption will meet the new definition of a patient-matched medical device and will therefore require inclusion in the ARTG.

If you are manufacturing or supplying these devices, transitional arrangements are in place to ensure you can continue to supply your device while you apply for it to be included in the ARTG. To access these arrangements you must submit this form before 25 August 2021. Once you have submitted this form, you will have until 1 November 2024 to submit an application for inclusion in the ARTG. More information about the inclusion process can be found on our website: https://www.tga.gov.au/publication/medical-device-inclusion-process