Vasyli Medical Asia Pacific - Orthosis, footwear, orthopaedic, shoe

Therapeutic Goods Act 1989

Approval under section 42DF for use of a restricted representation by Vasyli Medical Asia Pacific

I, Jane Cook, Office Head, Office of Product Review, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing, on receipt of an application by Vasyli Medical Asia Pacific, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representation described in paragraph (a) below for use in advertisements directed to consumers, for the product identified in paragraph (b), provided the condition identified in paragraph (c) is met:

1. "Diabetic" when used in the context of "diabetic foot complications"
2. 'Orthosis, footwear, orthopaedic, shoe' with the Australian Register of Therapeutic Goods entry number 159115.
3. The restricted representation "diabetic" must not be used in any context other than referring to "diabetic foot complications".

Dated this 11 day of April 2012

Jane Cook
Delegate of the Secretary to the Department of Health and Ageing; and
Office Head
Office of Product Review