Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025
The Australian Unique Device Identification Database, UDI labelling and identifier rules, mandatory adverse event reporting by healthcare facilities, and fee refunds, as made in F2025L00414.
Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 is a compliance framework from Australia with 6 domains and 21 controls. The largest domains are The database (7 controls), Adverse event reporting (4 controls), Labelling and patients (4 controls). Every control below carries what it requires and what an assessor expects to see.
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Framework Domains (6)
Adverse event reporting
Units of F2025L00414 grouped under Adverse event reporting.
| Code | Title |
|---|---|
| day-hospital | Day-hospital facilities are healthcare facilities |
| reporting-deadlines | Report within 10 or 45 days, electronically |
| stage-1-devices | Report Class III and Class 4 IVD events |
| stage-2-devices | Class IIa and IIb devices join on 1 April 2028 |
Fees
Units of F2025L00414 grouped under Fees.
| Code | Title |
|---|---|
| fee-refund | Claim the refund of certain condition fees |
Identifiers
Units of F2025L00414 grouped under Identifiers.
| Code | Title |
|---|---|
| issuing-agency | Use a recognised UDI issuing agency |
Labelling and patients
Units of F2025L00414 grouped under Labelling and patients.
| Code | Title |
|---|---|
| device-labelling | Provide the UDI on the device or pack |
| direct-marking | Directly mark reusable devices |
| package-identifier | Provide the package identifier |
| patient-card | Put both identifiers on the patient card |
Privacy and personal information
Units of F2025L00414 grouped under Privacy and personal information.
| Code | Title |
|---|---|
| public-database | Publish the database without representative data |
| removal | Remove information from the UDI database |
| representative-consent | Personal information and written consent |
| retention | Keep device records after suspension or cancellation |
The database
Units of F2025L00414 grouped under The database.
| Code | Title |
|---|---|
| 30-day-identifiers | Enter identifiers within 30 days |
| accuracy | Keep every entry accurate and current |
| application | Know which transaction triggers the duty |
| correction | Correct a database entry |
| device-data | Enter the 17 device data elements |
| review | Review a removal decision |
| udi-database | Establish and maintain the UDI database |
What is Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 and who does it apply to?
Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 is a compliance framework from Australia with 6 domains and 21 controls. The Australian Unique Device Identification Database, UDI labelling and identifier rules, mandatory adverse event reporting by healthcare facilities, and fee refunds, as made in F2025L00414. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 actually require?
Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 has 21 controls organised across 6 domains. The largest domains are The database (7 controls), Adverse event reporting (4 controls), Labelling and patients (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 do I already cover?
Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.
How do I implement Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025?
Start your Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 21 controls and track your progress.
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