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Conformity Assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including IVD medical devices) complies with the Essential Principles.
We have developed guidance material specific to Conformity Assessment for medical devices. This guidance material reflects updates to 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.