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Every duty in F2025L00414, one page each

The register holds 21 units that place a duty or set a date. Each page states the duty in our own words, the binding party, the evidence an auditor or regulator asks for, the dates and the exact citation. The source pointer is on every field.

Schedule 1: The database

• Sch 1 item 1, reg 9A.1(1) to (3)Establish and maintain the UDI databaseThe Secretary of the Department of Health and Aged Care, for the Commonwealth
• Sch 1 item 1, reg 9A.1(12)Correct a database entryThe Secretary as database operator
• Sch 1 item 2, reg 10.7(1)(e)Review a removal decisionA person affected by a decision under reg 9A.1(9), in practice.
• Sch 1 item 6, reg 13C.2(1) to (5)Enter identifiers within 30 daysThe sponsor or manufacturer responsible for the model, in practice. The clause is passive and does not name the party that lodges the entry.
• Sch 1 item 6, reg 13C.3(1) to (3)Enter the 17 device data elementsThe sponsor or manufacturer responsible for the device, in practice. The clause is passive and does not name the party that lodges the entry.
• Sch 1 item 6, reg 13C.4Keep every entry accurate and currentThe sponsor or manufacturer responsible for the entry, in practice. The clause is passive and does not name the party that keeps it current.
• Sch 1 item 8, reg 11.85(1) to (2)Know which transaction triggers the dutyThe party to the supply, import or export, in practice. The provision describes the transactions, not a named duty holder.

Schedule 1: Privacy and personal information

• Sch 1 item 1, reg 9A.1(4) to (5)Personal information and written consentThe Secretary as database operator. A sponsor or manufacturer that supplies representative information should apply the same limit in practice.
• Sch 1 item 1, reg 9A.1(6) to (7)Keep device records after suspension or cancellationThe Secretary as database operator
• Sch 1 item 1, reg 9A.1(8) to (11)Remove information from the UDI databaseThe Secretary as database operator, on a request from a sponsor or manufacturer or from an authorised representative
• Sch 1 item 1, reg 9A.1(13)Publish the database without representative dataThe Secretary as database operator. A sponsor or manufacturer that builds a public extract should keep representative information out in practice.

Schedule 1: Labelling and patients

• Sch 1 item 4, reg 13.5(1) to (4)Provide the UDI on the device or packThe manufacturer and the sponsor that supplies the device, in practice. The clause is passive.
• Sch 1 item 4, reg 13.6(1) to (2)Provide the package identifierThe manufacturer and the sponsor that supplies the device, in practice. The clause is passive.
• Sch 1 item 5, reg 13A.2(1)(a)(ii) and (b)(ii)Put both identifiers on the patient cardThe manufacturer and the sponsor that supplies the device, in practice. The clause is passive.
• Sch 1 item 6, reg 13C.5(1) to (2); Sch 1 item 7 direct marking start dayDirectly mark reusable devicesThe manufacturer. The clause says the mark must be made by the manufacturer.

Schedule 1: Identifiers

• Sch 1 item 6, reg 13C.1(1) to (4)Use a recognised UDI issuing agencyThe manufacturer, in practice. The clause is passive.

Schedule 2: Adverse event reporting

• Sch 2 item 1, reg 8AA.1Day-hospital facilities are healthcare facilitiesA day-hospital facility that meets the Act definition of healthcare facility.
• Sch 2 item 1, reg 8AA.2(a) to (b)Report Class III and Class 4 IVD eventsThe chief executive officer (however described) of a healthcare facility.
• Sch 2 item 1, reg 8AA.3(1) to (3)Report within 10 or 45 days, electronicallyThe chief executive officer (however described) of a healthcare facility.
• Sch 2 item 2; s 2 table item 4Class IIa and IIb devices join on 1 April 2028The chief executive officer (however described) of a healthcare facility, from 1 April 2028.

Schedule 3: Fees

• Sch 3 item 1, reg 43AG; Sch 3 items 2 to 3Claim the refund of certain condition feesThe Secretary, for a person who paid a qualifying fee

The four markets

The rule is Australian. A sponsor or facility that also operates in another market may owe a parallel duty there. The held rule sets below are the ones the scan selected for this buyer. Where a market has no held device rule, the section says what is named rather than held.

The other markets are named for context and are not included in the kit. The United States section names HIPAA and MDS2. No federal US unique device identification rule is held in the estate, so it is named, not stated. The European Union section names the MDR and the GDPR. The United Kingdom section names the UK GDPR and the Data Protection Act 2018. No UK device identification rule is held. The Australian section holds the instrument, the regulations it amends, the Act and the privacy law.

How to use the register

1. Start with the free check to get the start day for the device in front of you.
2. Open the unit pages that the check names. Each page has the requirement, the evidence, the gaps and the preparation steps.
3. Put the owner, the due date and the evidence in one register. The paid kit is that register, rendered from this record.