NOTIFICATION FORM: Transition arrangements for software-based medical devices

Closes 25 Aug 2021

Opened 4 Feb 2021

Overview

This form should be used by sponsors and manufacturers of software-based medical devices that will need to be included in the ARTG at a higher classification as a result of the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for transition if:

  • They are software-based medical devices intended for:
    • diagnosing and screening for a disease or condition; or
    • monitoring the state or progression of a disease or condition; or
    • specifying or recommending a treatment; or
    • providing therapy (via provision of information)

and either:

  • The device has been included in the Australian Register of Therapeutic Goods (ARTG) prior to 25 February 2021;  or
  • An application to include the device in the Australian Register of Therapeutic Goods (ARTG) is submitted prior to 25 February 2021.

Once you have submitted this form, you have until 1 November 2024 to submit an application for inclusion in the ARTG for the medical device as classified under the new applicable rules. More information about the inclusion process can be found on our website: https://www.tga.gov.au/publication/medical-device-inclusion-process

Details of the changes

From 25 February 2021, Part 4 of Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 will be amended to include four new classification rules (rules 4.5, 4.6, 4.7 and 4.8) for programmable and software-based medical devices (Note: these rules do not apply to in vitro diagnostic (IVD) devices). The rules specifically consider potential harm caused by providing incorrect information to users of these medical devices. The new rules apply to software-based medical devices intended for:

•         Rule 4.5: Diagnosing and screening for a disease or condition

•         Rule 4.6: Monitoring the state or progression of a disease, condition, etc.

•         Rule 4.7: Specifying or recommending a treatment

•         Rule 4.8: Providing therapy (via provision of information)

For further information about the new classification rules, please refer to the guidance document.

The new rules can be found in full in Part 4 of Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002.

If you have an eligible 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 under the new classification. 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 the medical device under the new classification. More information about the inclusion process can be found on our website: https://www.tga.gov.au/publication/medical-device-inclusion-process

 

Notification form

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