Medical devices (including IVD) have to be listed on the ARTG before they can be
- supplied in Australia
- imported into Australia
- exported from Australia
Understand that Colostat needs to be listed on ARTG in Australia any which way you look at it before selling into other jurisdictions.
Importing or exporting the product must be listed on ARTG. I'm going on what it says on TGA website.
I thought I explained this in my first post.
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- Why isn't Colostat being sold into European markets and NZ?
Why isn't Colostat being sold into European markets and NZ?, page-17
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