A plan with two clocks
Eight moves, and only one of them waits for 1 July 2027.
The plan starts with the ICR edition, because that change is already in force. The in-house IVD work starts now as an inventory and a classification, not as a policy, and the gap assessment follows. The last move re-dates the record after the accreditation conversation.
| When | Move | What it involves | Provision | Evidence to keep |
|---|---|---|---|---|
| Now | Confirm the edition in the document register | Replace the ICR Fifth Edition 2022 with the Sixth Edition 2026. Record the retrieval date and the working address. Check that the parent compilation you cite is dated on or after 13 July 2026. | Sch 1 item 9; s 2 | A register entry with the edition and the date. |
| Within 14 days | Gap-assess Standard 4 | Compare the messaging you run with the Sixth Edition wording: an Australian-approved electronic messaging standard, a minimum of HL7 Version 2.4 as localised for Australia, and flexibility to adopt HL7 FHIR. Record the interfaces, the versions and the vendor evidence. | Sch 1 item 9; Explanatory Statement | A Standard 4 gap assessment with owners and dates. |
| Within 30 days | Remove approvals in principle | Search the application guide, the delegation schedule, the forms and the quality manual for the phrase. Remove the step and annotate any legacy file. Brief the approver on the single approval test. | Sch 1 items 1 to 8 | A revised procedure, form and delegation. |
| Within 30 days | Reconcile the scope | Check that the NATA assessment report, the approval scope and the application use the same kinds of service and the same category. Record the reconciliation. | 2017 Principles ss 11(2) and 11(4) | A line-by-line scope reconciliation. |
| Within 60 days | Inventory the in-house IVDs | List every in-house IVD and every in-house IVD software item, including embedded, device-driving and standalone software and any AI or machine learning component. Name an owner for each. | Sch 1 item 11; Explanatory Statement | A complete inventory with owners. |
| Within 90 days | Classify and risk-assess | Record the class 1, 2 or 3 classification under the Therapeutic Goods (Medical Devices) Regulations 2002 and the reasoning. Add data governance and cybersecurity controls to the risk assessment. | Explanatory Statement, 2026 In-house IVD Standard | A classification record and a risk assessment per item. |
| Before 1 July 2027 | Gap-assess the Sixth Edition and validate | Map the quality system to the Sixth Edition 2026, close the gaps, validate each item and put software change control on the audit programme. Record the companion diagnostics wording change. | Sch 1 item 11 | A mapped gap assessment, validation records and a change control procedure. |
| After the assessment | Re-date the record | Replace the plan with the date NATA gives and the edition it confirms. Ask NATA in writing which edition it will assess against at the next visit. | Accreditation relationship | A written answer and a re-dated plan. |
Put it on the annual document review
Add the two Sixth Edition 2026 documents to the annual document review agenda, with a named reviewer and a date. The review is where the edition, the retrieval date and the owner are checked together.
A one-page board note
Write one page for the board that separates the ICR change already in force from the in-house IVD change in 2027. Name the money and the risk: the ICR messaging work, the in-house IVD inventory and the assessment date. Do not give the board a single countdown.
What the kit adds
The free plan is the sequence. The USD 799 kit carries the same moves in a working register with an owner, a status, a due date and an evidence pointer on every provision, plus the evidence sheet and the party map, in PDF, CSV and XLSX. See the kit.
Not legal advice; does not certify. The in-house IVD date is in the instrument. The day counts are planning aids, not deadlines created by this site.