Powered insulin infusion pumps & insulin pump administration sets

Published in the Commonwealth of Australia Gazette No. GN 49, 8 December 2004

THERAPEUTIC GOODS ACT 1989

THERAPEUTIC GOODS REGULATIONS

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 Section 42DF(1) of the Therapeutic Goods Act 1989, give notice that the restricted representation described in paragraph (a) below, has been approved for use in advertisements directed to consumers, for the category of products listed in paragraph (b) provided the conditions identified in paragraph (c) are met:

1. Representations to the effect that use of the goods described in paragraph (b) below:
   "used in the treatment of diabetes for people diagnosed with this condition";
2. Powered insulin infusion pumps and insulin pump administration sets; and
3.  
   1. The medical devices must first be included in the Australian Register of Therapeutic Goods.
   2. Advertisements in which the representation is made must comply with the Therapeutic Goods Advertising Code and must advise consumers to seek advice from their medical practitioner.
   3. Advertisements for the goods in which the representation is made must not refer, either directly or indirectly, to any (Schedule 4) prescription-only medicine.

Dated this 26th day of November 2004

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