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Conformity assessment is the systematic and ongoing examination of evidence and the application of procedures to ensure a medical device complies with the Essential Principles for medical devices.
Evidence that a device has undergone an appropriate Australian conformity assessment procedure, or comparable overseas regulatory pathway, must be held by the manufacturer before a device can be included in the Australian Register of Therapeutic Goods (ARTG).
The guidance document Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) provides an overview of suitable regulatory evidence options.
Refer to Table 2 for details of the information that must accompany ARTG inclusion applications for the purpose of passing preliminary assessment.