Tag: Australian Sponsor
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Do I Need an Australian Sponsor for My Medical Device? | Practical RA
Do I Need an Australian Sponsor for My Medical Device? If you’re an overseas manufacturer looking to sell your medical device or IVD in Australia, the short answer is almost certainly yes: you need an Australian Sponsor. But what exactly does that mean, what are they responsible for, and what happens if you don’t have…
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CE Marking to TGA: How to Use Your EU MDR Certification to Enter the Australian Market
CE Marking to TGA: How to Use Your EU MDR Certification to Enter the Australian Market If your medical device already holds CE Marking under EU MDR 2017/745, you may be closer to selling in Australia than you think. The TGA recognises EU MDR certification as valid manufacturer evidence for ARTG inclusion, meaning you can…