Medical Developments International - Portable Nebulizer

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Medical Developments International Ltd

I, Leanne McCauley, Director, Advertising Compliance Unit, Regulatory Practice, Education and Compliance Branch and Delegate of the Secretary to the Department of Health, on receipt of an application from Medical Developments International Limited, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in advertisements directed to consumers, for the product identified in paragraph (b), provided the conditions identified in paragraph (c) are met:

1. Representations to the effect that the product identified in paragraph (b) is:
   • Designed to deliver asthma and COPD medication into the lungs.
   • Intended for delivering asthma and COPD medication where pMDI and spacer cannot be utilised.
2. Portable Nebulizer (nebulizer, non-heated - ARTG No. 265972)
3. This approval is subject to the conditions that:
   1. the representations may only be used in advertisements for the Device which contain the advisory statement:
      Only to be used on the advice of your doctor (or words to that effect);
   2. the representation: 'Designed to deliver asthma and COPD medication to the lungs' must only be used in conjunction with the representation: 'Intended for delivering asthma and COPD medication where pMDI and spacer cannot be utilised'; and
   3. the acronym pMDI and/or the term 'pressurised Metered Dose Inhaler' must always be clarified by including the word 'puffer' in brackets immediately adjacent.

Dated this 7th day of December 2016

Leanne McCauley
Delegate of the Secretary to the Department of Health; and
Director
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch