Latest / Medical Device Global Market Access
From Europe to Down Under: A Guide to TGA Approval with Your CE Mark
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…
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