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Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by SiSU Wellness Pty Ltd
I, Michael Shum, as a delegate of the Secretary to the Department of Health, Disability and Ageing, on receipt of an application from SiSU Wellness Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representation described in paragraph (A), for use in advertisements for the product identified in paragraph (B), and under section 42DF(3) of the Act, I have decided to impose a condition on the approval of the use of the restricted representation, which is outlined in paragraph (C).
(A)
- ‘Diabetes risk’
(B)
- SiSU Health Station – Patient monitor module, multifunction (ARTG 317543)
(C)
- The restricted representation ‘diabetes risk’ must only be used in advertising about the ‘SiSU Health Station – Patient monitor module, multifunction (ARTG 317543)’ when referring to an established health questionnaire about the risk of developing type 2 diabetes that is relevant to the Australian population, such as ‘The Australian Type 2 Diabetes Risk Assessment Tool (AUSDRISK)’.
Dated 1 August 2025
Signed electronically
Michael Shum
Delegate of the Secretary to the Department of Health, Disability and Ageing
Education Policy and Guidance Section
Regulatory Compliance Branch