The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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.