Meters for monitoring blood glucose levels

Published in the Commonwealth of Australia Gazette No. GN 5, 6 February 2008

This approval replaces a comparable approval which was issued on 29 September 2003 under the former Therapeutic Goods Regulation 7C.

THERAPEUTIC GOODS ACT 1989

I, RITA MACLACHLAN, Director, Office of Devices, Blood and Tissues, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing for the purposes of subsection 42DK(1) of the Therapeutic Goods Act 1989 give notice that the restricted representations described in paragraph (a) below, have been approved for use in advertisements directed to consumers, for the goods listed in paragraph (b) provided the conditions identified in paragraph (c) are met

1. Representations to the effect that advertisements to consumers for the goods described in paragraph (b):
   • "assist in the monitoring of blood glucose levels for people diagnosed with diabetes mellitus";
2. Meters for monitoring blood glucose levels;
3. The device must first be entered in the Australian Register of Therapeutic Goods. The advertisement in which the representation is made must comply with the Therapeutic Goods Advertising Code as defined in subsection 3(1) of the Therapeutic Goods Act 1989, and must advise consumers to seek advice from their medical practitioner.

Dated this 18th day of January 2008

RITA MACLACHLAN
Delegate of the Secretary to the Department of Health and Ageing