Tag: Australian market access
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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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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…