Keep the ICR edition in the document register and a Standard 4 gap assessment with interface and conformance evidence. Keep the in-house IVD inventory, classification and risk assessment. Keep the revised approval procedure and the reconciliation between the NATA report, the approval and the application.
For the ICR limb, keep the document register entry naming the Sixth Edition 2026, an inventory of every messaging interface and version, vendor conformance statements, the My Health Record upload evidence and the FHIR position. For the in-house IVD limb, keep the inventory of devices and software, the class 1 to 3 classification and its reasoning, the risk assessment including data governance and cybersecurity, the validation records and the change control procedure. For the approval machinery, keep the procedure with no in-principle stage, the revised forms, the delegation and the scope reconciliation between the NATA report, the approval and the application. Each provision page on this site lists the artefacts an assessor commonly samples.
Where do the evidence lists come from?
Each provision page lists the artefacts an assessor commonly samples. They are our statement, not a quotation from NATA guidance.
Does the kit add evidence?
No. It puts the same evidence into a working register with owner, status and due date columns.
Where this comes from
The register states each provision in our own words and cites the section or item. The dates page separates the two commencements. The official text is F2026L00927 on the Federal Register.
Not legal advice; does not certify. The standards themselves are separate documents and are not reproduced here.