Wednesday, February 15, 2017

Bicycle helmets are medical devices - yes/no

(The TGA got back to me today!)
Good Afternoon Sue 
Thankyou for your email to the Therapeutic Goods Administration 
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. Bicycle helmets when presented in such a way are captured by this order therefore these products are declared not to be therapeutic products under the Therapeutic Goods Act 1989.
Hence there are no entries for these products on the Australian Register of Therapeutic Goods.
I trust this is of some assistance
Kind regards
Medical Devices Information Unit
Medical Devices Branch
Therapeutic Goods Administration

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