Snorex Qld - Mandibular advancement splint

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Snorex Qld Pty Ltd

I, Mick O'Connor, A/g Head, Office of Product Review, 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 identified in paragraph (b), provided the condition identified in paragraphs (c) is met:  

1. Representations to the effect that advertisements to consumers for the goods described in paragraph (b) may refer to: "sleep apnoea".
2. "Mandibular Advancement Splint" (custom made medical device).
3. The advertisements in which the representation is made must:
   • Only be used in the context of the question: "Have you ever been diagnosed by your Medical Health Professional or Doctor with sleep apnoea" and this question must only be used in the context of the questionnaire used for assessment of consumer by Snorex staff and must not be used as a standalone question.

Dated this 2 day of July 2013

Mick O'Connor
Delegate of the Secretary to the Department of Health and Ageing; and
A/g Head
Office of Product Review