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Ashman
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roddy000, post: 182967 wrote:
We are selling a acupressure mat, sort of a massage device, which we get manufactured overseas under our brand name.

I was just haveing a look at http://www.tga.gov.au to understand if any “therapeutic” approvals via TGA apply to us. TGA doesn’t mention anything about massage devices so I’m looking for advice on whether our product requires any TGA approvals. It seems TGA is mainly relevant to medical appliances and medicines. But – I just want to confirm for peace of mind.

There is a page about excluded goods http://www.tga.gov.au/industry/legislation-excluded-goods-order-1101.htm#.UvGC4fmSz94 but this didn’t help me either.

Any help is much appreciated

Roddy

I have been dealing with the TGA since 2005. Your product needs to be registered if it makes any claims about efficacy. So if your product claims that it has the ability to produce a desired or intended result regarding health and well being then it needs to be registered.