The approval process lost its in-principle stage and two Schedule 1 entries changed. The information communication and reporting Sixth Edition 2026 applies now, and the in-house IVD Sixth Edition 2026 applies from 1 July 2027 to laboratories that develop or use in-house IVDs.
Eight items remove the words "in principle" from the parent provisions that describe the Minister's approval powers, the object, the approval test, the six-month bar, the assessment-report condition, the amended-application route and the two interim approval provisions. Two items substitute Schedule 1 entries. Item 9 replaces the ICR standard with the Sixth Edition 2026, which the Explanatory Statement says amends Standard 4 so that laboratories conform with an Australian-approved electronic messaging standard, with a minimum of HL7 Version 2.4 as localised for Australia and flexibility to adopt HL7 FHIR. Item 11 replaces the in-house IVD standard with the Sixth Edition 2026 from 1 July 2027, adding quality standards for in-house IVD software and changing the companion diagnostics wording. Item 10 replaces the free-access note.
Did the high-confidence test change?
No. The threshold remains. The amendment removes the in-principle branch, not the standard of confidence.
Did the assessment report requirement change?
The requirement remains: the report must support the approval for the kinds of service and the category applied for. The amendment removes the reference to an in-principle approval.
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.