Australasian Medical & Scientific Ltd - Glucose monitoring system, G6 Sensor Kit, Device System

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Australasian Medical & Scientific Ltd

I, Michael Shum, as a delegate of the Secretary to the Department of Health and Aged Care, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in paragraph (A), for use in advertising the products identified in paragraph (B) to consumers.

1. 1. Representations referring to “diabetes" in the context of the Applicant's and manufacturer’s trading names.
   2. Representations to the effect of “This product is a continuous glucose monitoring system indicated for the management of (type 1, type 2, gestational) diabetes in people age 2 years and older where self-monitoring of blood glucose (SMBG) is indicated”.
   3. Representations to the effect of “Anyone 2 years and older living with (type 1, type 2, gestational) diabetes may benefit from continuous glucose monitoring/CGM where self-monitoring of blood glucose (SMBG) is indicated”.
   4. “for people living with diabetes” this representation will only be used in advertisements that include the representation “this product is indicated for persons with diabetes mellitus age 2 years and older where self-monitoring of blood glucose (SMBG) is indicated”.
   5. “Integrates with diabetes management applications”.
   6. “Manage your diabetes with ZERO fingerpricks and no calibrations, even for treatment decisions” (the Fingerprick Statement).
   7. “If your glucose alerts and readings from the G6 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions” (the Advisory Statement), with the Advisory Statement prominently displayed or communicated adjacent, or in close proximity to the Fingerprick Statement, whenever the Fingerprick Statement is used in consumer advertising.
   together, (the Representations).
2. Glucose monitoring system, in vivo (ARTG 169241)
   G6 Sensor Kit - Subcutaneous glucose sensor (ARTG 330535)
   Self-care monitoring web-based application software (ARTG 285956)
   together, (the Device System).

Dated this 29th day of September 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