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: TGA Updates Application Audit Rules for Medical Devices and IVDs: What Manufacturers Need to Know – February/March 2025

• 2025-02-21 05:10:50

The Therapeutic Goods Administration (TGA) has updated its application audit guidance for medical devices and in-vitro diagnostics (IVDs), to streamline regulatory processes and focus on high-risk devices. Additionally, the transition from the EU In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) introduces stricter requirements and extended transition periods for compliance. Medical device manufacturers must ensure thorough documentation and timely submissions to meet these evolving standards.

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Australia: TGA updates its guidance for software based medical devices - August/September 2024

• 2024-09-17 05:57:50

Australia's TGA has issued two new guidance on software-based medical devices. Sponsors must comply with the new classification rules with the transition period ending by November 1, 2024. Additionally, the TGA clarified which software products are subject to regulation, providing clear guidelines for industry.

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