Tag: ARTG
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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 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 often bypass a full TGA conformity assessment entirely. Here’s what you need to know. Why Australia…