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The Therapeutic Goods Administration (TGA) has issued two infringement notices totalling $26,640 to Sydney-based company Healy World Australia Pty Ltd (Healy World), for advertising an "analgesic TENS system" in alleged breach of the Therapeutic Goods Act 1989 (the Act).
Healy World is the sponsor of a 'transcutaneous electrical nerve stimulation' (TENS) medical device included in the Australian Register of Therapeutic Goods (ARTG). The company allegedly advertised the TENS device for a purpose that is not the purpose of the device in the ARTG. Under the Act, this kind of conduct amounts to false advertising. Sponsors are reminded that they have ongoing responsibilities once a medical device has been included in the ARTG.
It is also alleged that the company's advertising contained a prohibited representation about the TENS device, being a reference to a serious condition, with references to depression, anxiety and associated sleep disturbances, without the relevant regulatory permission from the TGA.
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.