From Europe to Down Under: A Guide to TGA Approval with Your CE Mark

Medical Device Global Market Access

This episode breaks down the process of using your existing European CE Marking to register a medical device in Australia. We cover the essential role of Manufacturer's Evidence, the TGA's application process and timelines, potential audits, and the latest on fees and charges, providing a clear roadmap for MedTech companies looking to enter the Australian market. Key Questions: • What is "Manufacturer's Evidence" and why is it the key to TGA approval? • How does my EU device classification translate to the Australian system? • Can I still use a legacy MDD certificate for a new TGA application? • What recent changes affect high-risk Class III and IVD devices? • What are the typical timelines for a TGA review based on a CE mark? • Is my device guaranteed to be audited by the TGA? • How much does a TGA application cost, and have fees changed recently? • What is an Australian Sponsor and why do I need one? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide, including TGA submissions and Australian Sponsor services. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.