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I, Tracey Lutton, as delegate of the Secretary of the Department of Health, Disability and Ageing, make the following permission.
Dated 28 January 2026
Tracey Lutton
Assistant Secretary
Regulatory Compliance Branch
Health Products Regulation Group
Department of Health, Disability and Ageing
Contents
- Name
- Commencement
- Authority
- Definitions
- Permission
- Repeals
Schedule 1 - Permission
Schedule 2 - Repeals
Meters for monitoring blood glucose levels
Powered insulin infusion pumps & insulin pump administration sets
1 Name
This instrument is the Therapeutic Goods (Restricted Representations—Diabetes Devices) Permission 2026.
2 Commencement
- Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information | ||
|---|---|---|
Column 1 | Column 2 | Column 3 |
Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | The day after this instrument is made. | 29 January 2026 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
- Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under section 42DK of the Therapeutic Goods Act 1989.
4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
accessory;
advertise;
device number;
included in the Register;
medical device;
Register;
Therapeutic Goods Advertising Code.
In this instrument:
Act means the Therapeutic Goods Act 1989.
active implantable medical device has the same meaning as in the MD Regulations.
Class I medical device has the same meaning as in the MD Regulations.
Class IIa medical device has the same meaning as in the MD Regulations.
Class IIb medical device has the same meaning as in the MD Regulations.
Class III medical device has the same meaning as in the MD Regulations.
Class 3 IVD medical device has the same meaning as in the MD Regulations.
device for measurement of blood glucose levels means an IVD medical device for self-testing that:
- is included in the Register; and
- is classified as a Class 3 IVD medical device, other than an implantable medical device or an active implantable medical device; and
- has an intended purpose, certified under section 41FD of the Act and accepted in relation to the inclusion of the device in the Register, that relates to the use of the device by a lay person in relation to diabetes mellitus.
device for measurement of blood glucose levels that incorporates ketone test strips means an IVD medical device for self-testing that:
- is included in the Register; and
- has the same ARTG number as a device for measurement of blood glucose levels; and
- is classified as a Class 3 IVD medical device when in combination with a device for measurement of blood glucose levels, other than an implantable medical device or an active implantable medical device; and
- has an intended purpose, certified under section 41FD of the Act and accepted in relation to the inclusion of the device in the Register, that relates to the use of the device by a lay person in relation to diabetes mellitus.
device for measurement of interstitial-fluid glucose levels means a medical device for self-testing, that:
- is included in the Register; and
- is classified as a Class IIb medical device, other than an implantable medical device or an active implantable medical device; and
- has an intended purpose, certified under section 41FD of the Act and accepted in relation to the inclusion of the device in the Register, that relates to the use of the device by a lay person in relation to diabetes mellitus.
diabetes includes diabetes mellitus.
implantable medical device has the same meaning as in the MD Regulations.
intended purpose has the same meaning as in the MD Regulations.
IVD medical device for self-testing has the same meaning as in the MD Regulations.
MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
prominently displayed or communicated has the same meaning as in the Therapeutic Goods Advertising Code.
relevant companion software application means a software application that is:
- included in the Register; and
- classified as a Class I, Class IIa, Class IIb or Class III medical device.
relevant insulin pump means an insulin pump that:
- is included in the Register; and
- is classified as a Class IIb or Class III medical device, other than an implantable medical device or an active implantable medical device; and
- has an intended purpose, certified under section 41FD of the Act and accepted in relation to the inclusion of the device in the Register, that relates to the use of the device by a lay person in relation to diabetes mellitus.
relevant medical device means a medical device that:
- is included in the Register as any one of the following:
- pen needle;
- insulin syringe;
- electronic insulin pen;
- lancets or lancing device;
- test strips designed to measure blood glucose in blood when used in combination with a dedicated blood glucose meter; and
- has an intended purpose, certified under section 41FD of the Act and accepted in relation to the inclusion of the device in the Register, that relates to the use of the device by a lay person in relation to diabetes mellitus.
relevant subsidised medical device means a medical device that:
- is included in the Register; and
- is included as a subsidised product on the National Diabetes Services Scheme; and
- has an intended purpose, certified under section 41FD of the Act and accepted in relation to the inclusion of the device in the Register, that relates to the use of the device by a lay person in relation to diabetes mellitus.
restricted representation means a representation referred to in section 42DD of the Act.
5 Permission
For subsection 42DK(1) of the Act, in relation to each item in the table in Schedule 1, the representations specified in column 2 (to the extent that those representations are restricted representations) are permitted to be used in advertisements about the therapeutic good specified in column 3, subject to the conditions (if any) specified in column 4.
6 Repeals
Each instrument that is specified in Schedule 2 to this instrument is repealed as set out in the applicable items in that Schedule.
Schedule 1 - Permission
Note: See section 5.
Permitted use of restricted representations | |||
|---|---|---|---|
Column 1 | Column 2 | Column 3 | Column 4 |
Item | Restricted representation | Therapeutic good | Conditions |
| 1 | one or more of the following:
| a device for measurement of interstitial-fluid glucose levels | all of the following:
|
| 2 | one or more of the following:
| a device for measurement of blood glucose levels | all of the following:
|
| 3 | one or more of the following:
| a relevant insulin pump | the advertisement must not be inconsistent with the intended purpose of the therapeutic good or with any conditions relating to the inclusion of the good in the Register |
| 4 | one or more of the following:
| a relevant companion software application:
| all of the following:
|
| 5 | a representation to the effect that the therapeutic good is intended for any of the following:
| a relevant companion software application:
| all of the following:
|
| 6 | a representation to the effect that the therapeutic good is intended for any of the following:
| a relevant companion software application:
| all of the following:
|
| 7 | one or more of the following:
| a medical device for measurement of blood glucose levels that incorporates ketone test strips when used as an accessory to the therapeutic good specified in column 3 of item 2 | all of the following:
|
| 8 | one or more of the following:
| a relevant medical device | the advertisement must not be inconsistent with or extend beyond the intended purpose of the therapeutic good or with any conditions relating to its inclusion in the Register |
| 9 | one or more of the following:
| a relevant subsidised medical device | the advertisement must not be inconsistent with or extend beyond the intended purpose of the therapeutic good or with any conditions relating to its inclusion in the Register |
Schedule 2 - Repeals
Note: See section 6.
Meters for monitoring blood glucose levels
1 The whole of the instrument
Repeal the instrument.
Powered insulin infusion pumps & insulin pump administration sets
2 The whole of the instrument
Repeal the instrument.