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.
-
TopicIn some circumstances you may need to obtain TGA conformity assessment certification.
More information
- Australian Conformity Assessment Bodies (Australian CABs)
- Conformity assessment certificates, changes to requirements for certain medical devices
- Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices
- Comparable overseas regulators for medical device applications
- Overseas regulator evidence options for a medical device application