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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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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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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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Brazil ANVISA Regulatory Approval Process for IVDs
Manufacturers need to obtain ANVISA (​ Agência Nacional de Vigilância Sanitária ) approval prior to selling their products in Brazil. Brazil has four
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Introduction to Brazil's Medical Device Approval Process
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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