Dear Medical Devices Information Unit,
Thank you for your response to my email.
Given that the Therapeutic Goods
(Excluded Goods) Order No 1 of 2011 specifically excludes non-sterile
protective or safety apparel or equipment used in the home or for occupational
or recreational use from regulation by the TGA and that bicycle helmets when
presented in the way I presented them to you in my email are captured by
this order, I can only conclude that a bicycle helmet is a medical device.
I do not use a bicycle helmet in
the home or for occupational use or recreational use, and should I choose to
wear a bicycle helmet on a bicycle, it would be for the purposes of transport
and traffic and not for the purposes for use in the home or for occupation or
recreational use.
Prima facie I remain of the
opinion that a bicycle helmet in my particular situation is a medical device
and therefore requires my informed consent rather than compulsory regulation by law.
Kind regards,
Sue Abbott
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