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Australian regulatory evidence options for a medical device application
Information on Australian evidence options including TGA conformity assessment certification.
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. Link is at bottom of the guidance document.
- GuidanceSelf-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.
- 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