Resources

All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.

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Learn about the Australian TGA regulations which apply to medical devices
Australia TGA Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Australia. LOG INTO RAMS
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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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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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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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In Depth: Brazil Medical Device Approval and Compliance
Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK.
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Brazil QMS Requirements For Medical Device Manufacturers
Thinking about selling your medical device in Brazil? If so, you should know that the Brazilian medical device and IVD market is complex. The
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