Australian regulatory evidence options for a medical device application

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.