The Therapeutic Goods Administration (TGA) controls medical devices in Australia according to criteria prescribed by the Therapeutic Goods (Medical Devices) Regulations 2002. The regulatory environment in Australia is quite similar to that in Europe. Indeed, if a device has the European CE Marking, the classification will probably be consistent and the approval process will be easier since the CE Marking is generally accepted by the TGA.
Regulations for other markets, Page 1 of 2
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