"any instrument intended to be used for human beings for the purpose of modification of the anatomy...that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means"
Check: bicycle helmets & condoms
But then just as we get our heads around that, section 41BD goes on to perform some classic legislative acrobatics by stating in subsection (3) that:
"the Secretary may, by order published in the Gazette, declare that a particular instrument, is not, for the purposes of this Act, a medical device."...and that declarations under section 7 subsection 4 can have this affect too!
Talk about 'mingy'! - and weirdly just to add to our confusion, there's a little 'note' placed after that 'subsection 3 mingy bit' which in turn notes that "a declaration under this section does not stop articles from being therapeutic goods." !!!!
So off we go in an 'Alice in Wonderland' sort of fashion to the TGA's section 3 interpretation where we now find that 'therapeutic goods' are, among other things, 'medical devices'!!
Check: bicycle helmets & condoms (I think)
I feel it's now imperative that we have a peep at the Secretary's order in the Gazette so that we can step back and marvel at Government's attention to detail!!! No way were they ever going to countenance leaving bicycle helmets as medical devices - you see they can't force people to wear medical devices - there's the tricky little issue of consent!!!!
Conveniently the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 published in the 'Commonwealth of Australia Gazette, No. S91, 31 May 2011' sets out neatly for us 'Goods that are not therapeutic goods' and 'Goods that are not therapeutic goods when used, advertised, or presented for supply in a particular way'...
...and it's where item no. 4 in Table 1 jubilantly declares "non-sterile protective or safety apparel or equipment" goods when their "specified use, advertisement or presentation for supply" is "use in the home or for occupational or recreational use" that finally eliminates bicycle helmets as medical devices - poor show, Dr Rohan Hammett, Delegate of the Secretary of the Department of Health and Ageing, making that Order under subsection 7(1) of the Act!
Maybe it's the 'non-sterile' element that let bicycle helmets down in the medical device department - but then not all bandages are sterile are they?