TGA & Industry Updates
Regulatory reform, sponsorship and reimbursement, explained for sponsors working the Australian pathway.
Entering The Australian Medical Device Market: A Practical Guide
Entering the Australian medical device market requires more than submitting an application to the Therapeutic Goods Administration (TGA). Instead, the appropriate pathway depends on your device, its intended…
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What The Latest TGA UDI Guidance Means For Medical Device Manufacturers
Australia's Unique Device Identification (UDI) framework has moved from preparation to implementation. As a result, it brings new compliance responsibilities for medical device manufacturers and sponsors supplying devices…
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A Guide To Appointing Your Australian Sponsor
What your Australian Sponsor is responsible for — and the questions to ask before appointing one. For an overseas medical device manufacturer planning to enter the Australian market,…
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