NOTIFICATION FORM: Transition arrangements for medical devices that record patient images, and anatomical models

Closes 25 Aug 2021

Opened 21 Sep 2020

Overview

This form should be used by manufacturers and sponsors of medical devices that record patient images or that are anatomical models, and that will be reclassified by the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for transition if:

  • they are medical devices intended to record patient images that are acquired using a method that relies on energy outside the visible spectrum; or
  • they are medical devices that are virtual or physical anatomical models; or
  • they are programmed or programmable medical devices, or software that is a medical device, intended to be used to generate a virtual anatomical model; and
  • the patient images or anatomical models are to be used for the diagnosis or monitoring of a disease, injury of disability and/or the investigation of the anatomy or of a physiological process; and
  • the device has been included in the Australian Register of Therapeutic Goods (ARTG) as a Class I medical device prior to 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

From 25 February 2021, clause 5.4 (also called classification rule 5.4) of Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 will be updated to capture a broader range of technologies now being used to record patient images. It will be revised to state:

(1)  If:

(a)  a medical device is intended by the manufacturer to be used to record patient images that are to be used for either or both of the following:

(i)  the diagnosis or monitoring of a disease, injury or disability;

(ii)  the investigation of the anatomy or of a physiological process; and

(b)  the images are to be acquired through a method that relies on energy outside the visible spectrum;

the device is classified as Class IIa.

(2)  A medical device that is an anatomical model (whether physical or virtual) that is intended by the manufacturer to be used for either or both of the following:

(a)  the diagnosis or monitoring of a disease, injury or disability;

(b)  the investigation of the anatomy or of a physiological process;

is classified as Class IIa.

 (3)  A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to generate a virtual anatomical model that is to be used for either or both of the following:

(a)  the diagnosis or monitoring of a disease, injury or disability;

(b)  the investigation of the anatomy or of a physiological process;

is classified as Class IIa.

If you have a Class I medical device inclusion in the ARTG with a start date before 25 February 2021 for a device described above, 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 as a Class IIa medical device. To access these arrangements you must submit this form before 25 August 2021. Once you have submitted this form, you have until 1 November 2024 to submit an application for inclusion in the ARTG for a Class IIa medical device. More information about the inclusion process can be found on our website: https://www.tga.gov.au/publication/medical-device-inclusion-process

 

Audiences

  • Anyone from any background

Interests

  • Health technology