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Australia: TGA released guidance to clarify the regulatory obligations of sponsors and manufacturers with exempt medical devices - August/September 2024

Australia: TGA released guidance to clarify the regulatory obligations of sponsors and manufacturers with exempt medical devices - August/September 2024

  • 2024-09-17 06:17:58

Australia's TGA has issued new guidelines for exempt medical devices, clarifying that while not requiring ARTG registration, these products still face strict oversight. Manufacturers must adhere to reporting, recall, advertising, and quality standards to ensure patient safety. Non-compliance can result in penalties.

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