If you are thinking about entering the Australian market for the first time, understanding the Therapeutic Goods Association (TGA) regulatory requirements can be overwhelming. Information about medical device regulations on the TGA website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer.
To help medical device manufacturers who want to export medical devices to Australia, we assembled a packet that includes the basic information you need before deciding to enter the Australian market. It outlines the registration requirements and ongoing obligations to maintain compliance.
If you set aside just one hour to read these items, we guarantee you will have a MUCH better understanding of how the TGA's regulatory process works.
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Thinking about selling your medical device or IVD in Australia or New Zealand? If your device already has CE Marking or approvals in other key mark
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