Tag: medical device registration Australia
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Singapore HSA Registration & Australian TGA: The Abridged ARTG Pathway | Practical RA
REGULATORY ALERT – AUSTRALIA How your Singapore HSA Approval Can Fast-Track TGA Registration in Australia If your medical device is registered with Singapore’s Health Sciences Authority, you already have most of what you need for Australian ARTG inclusion. Singapore-based manufacturers and Asia-Pacific distributors If your device is registered with Singapore’s Health Sciences Authority (HSA), you’re…
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Choosing an Australian Sponsor for Your Medical Device: What to Look For
REGULATORY ALERT – AUSTRALIA Choosing an Australian Sponsor for Your Medical Device: What to Look For The partnership between a manufacturer and Sponsor is a critical piece of your Australian market access puzzle. This guide will help you perform your due diligence and identify a competant a trusted partner for long-term success. Once you’ve established…
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Do I Need an Australian Sponsor for My Medical Device? | Practical RA
REGULATORY ALERT – AUSTRALIA Do I Need an Australian Sponsor for My Medical Device? If you’re an overseas medical device manufacturer looking to sell in Australia, you almost certainly need an Australian Sponsor. Here’s exactly when it’s required, what the Sponsor is responsible for, and what happens if you try to supply without one. Who…