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Alcohol wipes (regulation)
Since the gazettal of the Section 41BD(3) Order in April 2004, sponsors of alcohol swabs used on skin prior to injection have been advised that such products are considered to be antiseptic wipes and asked to submit an application for registration for an OTC medicine, with supporting data. However, manufacturers have been claiming that the intended purpose of alcohol wipes is to clean skin, not to disinfect.
The Therapeutic Goods (Medical Devices) Regulations 2002 require the TGA to respond to the manufacturer's intended purpose. If the manufacturer's intended purpose is only to clean the skin, then the product is a medical device. This is to clarify that the TGA will regulate alcohol swabs according to the claims made by the manufacturer as follows:
- Alcohol swab (with antiseptic claim) will be regulated as an over the counter medicine;
- Alcohol swab (with no claims other than cleaning skin) will be regulated as a medical device.
The Australian Medical Devices Guidance Document Number 35, Device - Medicine Boundary Products has been updated to clarify this position.