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Conformity assessment

30 June 2021

The TGA is developing guidance material specific to conformity assessment for medical devices to update the regulatory requirements in the Australian Regulatory Guidelines for Medical Devices (ARGMD).

The ARGMD provides more information on conformity assessment for medical devices. As the ARGMD is currently under review, any guidance listed here (which is also covered in the ARGMD) should be considered the latest version.

General information

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