Ascensia Diabetes Care Australia Pty Ltd - glucose monitoring system IVD, home-use/point-of-care

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Ascensia Diabetes Care Australia Pty Ltd

I, Michael Shum, as a delegate of the Secretary to the Department of Health and Aged Care, on receipt of an application from Ascensia Diabetes Care Australia Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in paragraph (A), for use in advertising the product identified in paragraph (B) to consumers.

1. Restricted representations to the effect of:
   1. "as an aid in measuring blood glucose levels and supporting a diabetes monitoring plan”
   2. "as an aid in measuring blood glucose levels and supporting a diabetes management plan”
   3. “for people with diabetes, including those on insulin therapy who rely on measuring blood glucose levels to make dosing adjustments”
      together, (the Representations).

The Representations will always be accompanied with an advisory statement to the effect “consult your healthcare professional to discuss if this product is right for you” (the Advisory Statement).

2.  
   1. Glucose monitoring system IVD, home-use/point-of-care (ARTG 196838)

Dated this 18th day of April 2023

Signed electronically

Michael Shum

Delegate of the Secretary to the Department of Health and Aged Care
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch