Tag: TGA
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AusUDID: Everything Australian Medical Device Sponsors Need to Know Before July 2026
REGULATORY ALERT – AUSTRALIA AusUDID: Everything Medical Device Manufacturers Need to Know Before July 2026 The TGA’s mandatory Unique Device Identification database is live and the compliance clock is ticking for Class IIb and Class III device sponsors. ⏱ 1 July 2026: Mandatory AusUDID compliance deadline for Class IIb & Class III medical devices What Is AusUDID —…
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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…
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CE Marking in Australia: How to Use EU MDR Certification for TGA Registration | Practical RA
REGULATORY ALERT – AUSTRALIA CE Marking in Australia : How to Use Your EU MDR Certification for TGA Market Access CE Marking can pave the way for market access all around the globe. Here’s why Australia should be at the top of your list of markets to expand into. If your medical device already holds…