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IVD guidance documents

In vitro diagnostic medical devices

The TGA is developing guidance specific for IVDs as part of the Australian Regulatory Guidelines for Medical Devices (ARGMD). The first of these chapters are now available. Further chapters are under development and are referenced in the current documents. These chapters will be available in the near future. In instances where there is no specific IVD guidance available the corresponding documents from the ARGMD may provide useful information.

Please note that these documents are provided for guidance. All regulatory decisions are made using legislation as set out in the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.

Any comments on the content of the IVD guidance can be directed to 1800 141 144 or email