Using Overseas Clinical Data
Overview
For most medical devices seeking ARTG inclusion, clinical evidence is drawn from overseas clinical data rather than Australian-specific trials. This is appropriate and accepted by the TGA — Australian patients are not significantly different from populations in most comparable countries, and the expense of conducting Australia-specific clinical trials for every device would be disproportionate. However, overseas clinical data must be carefully evaluated for relevance and quality before it can be relied upon.
Overseas Clinical Data in the CER
The Clinical Evaluation Report (CER) may draw on:
- Clinical investigation data generated in any country for the same or an equivalent device
- Peer-reviewed published literature on the device or equivalent devices
- Post-market surveillance data from overseas markets (adverse event reports, registry data, PMCF data)
- Clinical data from overseas regulatory submissions (e.g., FDA PMA summaries, EU clinical evaluation reports)
The key requirements are that the data is relevant to the intended Australian use, is of adequate quality (published in peer-reviewed journals, or from well-conducted studies), and is applicable to the Australian patient population.
Relevance to Australian Use
Overseas clinical data should be reviewed for potential differences between the overseas patient population and the Australian population that might affect generalisability. In most cases, these differences are minimal. However, for devices where intended use, clinical practice, or patient demographics may differ significantly between countries, this should be explicitly addressed in the CER.
Data from EU CE-Marking and FDA Approval
Clinical data submitted to support EU CE marking (under MEDDEV 2.7.1 or EU MDR Annex XIV) or FDA clearance/approval is generally relevant and well-documented. The TGA accepts overseas regulatory data as evidence in Australian applications. Sponsors may provide clinical evaluation reports, FDA 510(k) summaries, PMA summaries, and EU notified body assessment reports to support their ARTG applications.
Limitations on Equivalence Claims
Where overseas clinical data relates to a device claimed to be equivalent to the subject device, the equivalence must be rigorously documented. For higher-risk devices, regulators globally are applying stricter standards for what constitutes an acceptable equivalence claim. If clinical data from an equivalent device is used, the differences between the devices must not affect safety or clinical performance, and this must be argued with specific technical justification.