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Get smart about Australia in 1 hour
If you are thinking about entering the Australian market for the first time, understanding the Therapeutic Goods Association (TGA) regulatory
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What To Expect From Your Regulatory Representative
Are you hoping to export your device to other medical device markets? If so, most countries require you to appoint an in-country representative if
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Medical device registration in Australia and New Zealand
Medical Device Registration in Australia & New Zealand
Thinking about selling your medical device or IVD in Australia or New Zealand? If your device already has CE Marking or approvals in other key
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TGA - Australia Therapeutic Goods Administration
The Therapeutic Goods Administration is the Australian regulatory authority for therapeutic goods such as pharmaceuticals, blood products and tissues
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Transitioning to Medical Device Single Audit Program (MDSAP) Compliance
As the first year of its operational phase ends, the Medical Device Single Audit Program (MDSAP) is finally gaining traction among medical device
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Learn about basic demographic and healthcare market data on Australia
AUSTRALIA – Overview of medical device industry and healthcare stats
Below you will find basic demographic and healthcare market data on Australia, plus specific information about the medical device and healthcare
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Learn about the Australian TGA regulations which apply to medical devices
Australia TGA Medical Device Regulations
All documents listed below are available from the Australian Therapeutic Goods Administration (TGA) website. Please note that this information is
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