Medtronic Australasia Pty Ltd – CareLink Personal - Information system (ARTG 303062) Guardian - Diabetes patient management software (ARTG 398010) CareLink Connect / MiniMed Mobile - Diabetes patient management software (ARTG 408370)

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Medtronic Australasia Pty Ltd

I, Rowena Love, as a delegate of the Secretary to the Department of Health, Disability and Ageing, on receipt of an application from Medtronic Australasia Pty Ltd, have, under section 42DF of the Therapeutic Goods Act 1989, approved with a condition: 

• the restricted representations:
  •  Representations referring to “diabetes” in the context of the name “Medtronic Diabetes”.
  • For People Living with Diabetes.
  •  For People Living with Diabetes.
  • For People living with Type 1 Diabetes.
  • You can now view diabetes data on your smartphone.
  •  <Device Name or “the App” > Displays historical glucose trend data received from the compatible device.
  • CareLink Personal collects data from compatible devices. It generates reports that display glucose trends, insulin delivery, and other relevant data.
  • CareLink Personal allow you to review and analyse your diabetes data for personal management and to share reports with healthcare professionals.
    • for use in advertisements for the products:
      •  CareLink Personal - Information system (ARTG 303062)
      • Guardian - Diabetes patient management software (ARTG 398010).
      • CareLink Connect - Diabetes patient management software (ARTG 408370).
      • MiniMed Mobile - Diabetes patient management software (ARTG 408370).
• the restricted representation:
  • <Device Name or “the App”> Provides notifications on compatible devices when glucose levels are trending towards or reach user-defined high or low thresholds.
    • for use in advertisements for the products:
      • Guardian - Diabetes patient management software (ARTG 398010).
      • CareLink Connect - Diabetes patient management software (ARTG 408370).
      • MiniMed Mobile - Diabetes patient management software (ARTG 408370).
• the restricted representation:
  • The CareLink Connect app gives care partners remote access to pump and CGM data.
    for use in advertisements for the product ‘CareLink Connect - Diabetes patient management software’ (ARTG 408370).
• the restricted representations:
  •  MiniMed Mobile App for people living with Diabetes.
  • With the MiniMed Mobile app, you can track your glucose levels and receive notifications on your phone and Apple Watch if you are going high or low.
    • for use in advertisements for the product ‘MiniMed Mobile - Diabetes patient management software’ (ARTG 408370).

(together, the Representations)

This approval is subject to the following condition:

.  Advertisements in which any one of the Representations is used must comply with the Therapeutic Goods Advertising Code.

Dated this 28th day of May 2025

Signed electronically
Rowena Love
Delegate of the Secretary to the Department of Health, Disability and Ageing
Education, Policy and Guidance Section
Regulatory Compliance Branch