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.
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