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Qualtech Webinar: Unlocking ANZ Market Access – Australia TGA Updates & New Zealand Entry Made Simple – June 2026

Qualtech Webinar: Unlocking ANZ Market Access – Australia TGA Updates & New Zealand Entry Made Simple – June 2026

  • 2026-05-29 07:54:15

Join Qualtech's free webinar on June 18, 2026, to explore the latest regulatory developments and market access considerations for Australia and New Zealand. This session will provide practical insights into Australia TGA application pathways, key TGA updates in 2026, and the current regulatory framework in New Zealand, helping medical device manufacturers better prepare their ANZ market entry strategies.

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Australia: Australia Aligns with US FDA Standards: Faster Market Access for Class IIa and III Devices – December/January 2025

Australia: Australia Aligns with US FDA Standards: Faster Market Access for Class IIa and III Devices – December/January 2025

  • 2024-12-16 09:17:34

The updated Therapeutic Goods regulations in Australia, effective October 19, 2024, introduce streamlined documentation for medical devices assessed by the US FDA. By aligning with international standards, the changes simplify compliance for Class IIa and Class III devices, reducing burdens while ensuring safety and quality, offering manufacturers faster market access.

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