We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Different steps apply for different categories and types of devices.
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PageSubmitting an application in TBS for Class I non-sterile, non-measuring and Class 1 IVD medical devices.
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PageSubmitting an application in TBS for Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only).
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PageSubmitting an application in TBS (for all classes except Class I non-sterile, non-measuring medical device, Class 1 IVD medical device and Class I medical device/Class 1 IVD medical device Export Only).