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TGA Definition: Medical Device

The TGA defines a Medical Device according to the Therapeutic Goods Act 1989:

41BD What is a medical device

<ol>
<li>A medical device is:
<ol type=”a”>
<li>any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
<ol type=”i”>
<li>diagnosis, prevention, monitoring, treatment or alleviation of disease;</li>
<li>diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;</li>
<li>investigation, replacement or modification of the anatomy or of a physiological process;</li>
<li>control of conception;</li>
</ol>
and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or</li>
<li>an accessory to such an instrument, apparatus, appliance, material or other article.</li>
</ol>
</li>
</ol>
</blockquote>
<p style=”text-align: left;”></p>

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