Advertising exemption: Non invasive blood pressure monitors

Published in the Commonwealth of Australia Gazette No. GN 40, 10 October 2007

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 Section 42DF(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 products 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) may refer to:
   "high blood pressure / hypertension and that this can lead to serious health problems";
2. Non invasive blood pressure monitors that are entered in the Australian Register of Therapeutic Goods as "Included Medical Devices" and have an "intended purpose" to the effect of being devices which are used to measure blood pressure, comprising a cuff to restrict blood flow and a monitor to measure pressure; and
3. Subject to the conditions that all advertisements include explicit statements to the effect:
   1. that the advertising is directed at those patients with medically diagnosed hypertension only;
   2. that a medical practitioner is the only person qualified to evaluate the meanings of recorded blood pressure; and
   3. the device should be recalibrated every six (6) months to ensure on-going accuracy.

Dated this 2nd day of October 2007

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