Evidence
Using overseas evidence for Australian market access.
Many manufacturers entering Australia already hold approvals or certificates from other markets. These materials can be valuable, but they still need to be mapped carefully to Australian expectations.
Useful evidence sources
Overseas evidence may include EU MDR or IVDR certificates, FDA clearance or approval documentation, UKCA evidence, Health Canada licences, MDSAP certificates, ISO 13485 certificates, clinical evaluation reports, performance evaluation reports, and post-market data.
The existence of overseas approvals does not remove the need to assess Australian classification, intended purpose, labelling, manufacturer evidence, and sponsor responsibilities. The evidence should be reviewed for relevance, currency, scope, and product coverage.
Questions to answer early
- Does the overseas approval cover the same model, variant, intended purpose, and manufacturer?
- Is the evidence current and supported by a valid quality system certificate?
- Does the Australian classification align with the overseas classification?
- Are clinical or performance claims consistent across labels, IFU, and promotional materials?
- Are post-market and change records available if TGA requests them?
How Ocevia helps
Ocevia reviews overseas evidence against the Australian market entry pathway and identifies what can support ARTG inclusion, what needs clarification, and what may require additional documentation before submission.