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Government Approval - TGA Registration Details
The Australian Therapeutic Goods Administration (TGA) is the government body responsible for setting and maintaining the standards for medicines and medical devices in Australia.
Any device that is intended to treat a disease* must be registered with the TGA before it can legally be sold to the public in Australia. Unfortunately this doesn't seem to be very well policed, and plenty of unregistered devices are available, especially on the internet.
*The definition of "disease" includes snoring. I have a letter from the TGA to prove it!
Before a device can
be registered, the applicant must convince the TGA that
(1) the device performs as claimed and
(2) the benefit to Australians outweighs any side effects.
On 13th December 2004 the Snorer's Friend™ was granted registration as a Class 1 Medical Device under number ARTG#115164.
The registration specifically allows the Snorer's Friend to be sold to the public as a treatment for snoring, and specifically prohibits its sale as a treatment for OSA. So please don't ask me to sell you one as a treatment for your OSA. It would be a serious offence for both of us. If you want to try using the Snorer's Friend to treat your OSA please get your doctor to contact me. It's OK to use the device for OSA if a doctor supervises you. So just get them to call me or write to me and confirm that they are supervising your use of the device. My contact details are here.
Remember to look for TGA registration if you are considering other anti-snoring devices! If they have a TGA registration number, they are probably OK to use. If they don't, well, I'll let you make up your own mind as to why they aren't registered.
Here's my TGA certificate. Click thumbnails to see larger, legible version. It's fascinating reading, very hard to put down once you start, so be warned!