Back to Frameworks
Australia Therapeutic Goods (Medical Devices) Regulations 2002
Australia (Commonwealth)
vCompilation No. 72 (F2026C00883), compilation date 8 September 2026, registered 11 September 2026, incorporating amendments up to the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026 (F2026L01167)
10 domains
67 controls
Australia's Therapeutic Goods (Medical Devices) Regulations 2002: the essential principles, classification rules and conformity assessment procedures for medical devices and IVDs, the automatic conditions on ARTG entries (adverse event reporting periods, complaint and distribution records, annual reports), exemption and clinical trial conditions, mandatory healthcare facility reporting and the unique device identification rules.
Verified
Australia Therapeutic Goods (Medical Devices) Regulations 2002 is a compliance framework from Australia (Commonwealth) with 10 domains and 67 controls. The largest domains are Schedule 1 Part 2: other essential principles (clauses 7 to 15) – Australia Therapeutic Goods (Medical Devices) Regulations 2002 (19 controls), Part 3 Division 3.2 and Schedule 3: conformity assessment procedures – Australia Therapeutic Goods (Medical Devices) Regulations 2002 (17 controls), Part 5 and Part 6: inclusion in the Register and automatic conditions of inclusion – Australia Therapeutic Goods (Medical Devices) Regulations 2002 (7 controls). Every control below carries what it requires and what an assessor expects to see.
Maintained by Gerard Blokdyk
Framework summaries on this platform are interpretations grounded in the published source, for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.
Framework Domains (10)
Part 1 to Part 3 Division 3.1: preliminary, essential principles and classification (regulations 1.1 to 3.3) – Australia Therapeutic Goods (Medical Devices) Regulations 2002
1 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-medical-devices-regulations-2002::r3.2-3.3 | Classify every device by its intended purpose under Schedule 2 (non-IVD) or Schedule 2A (IVD), applying the regulation 3.3 principles for combinations, accessories, software, production systems and packs |
Part 10: sponsor identification and custom-made device notices – Australia Therapeutic Goods (Medical Devices) Regulations 2002
2 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-medical-devices-regulations-2002::r10.2 | Sponsor identification: provide the sponsor's name and address with the device so users can readily identify the sponsor, located as clause 13.2 requires, and never let an added label adulterate the device or obscure the manufacturer's information |
| australia-therapeutic-goods-medical-devices-regulations-2002::r10.3-10.3A | Custom-made devices: notify the Secretary within 2 months of first manufacture in Australia or first import, and give an annual report on the approved form before 1 October covering all custom-made devices made or imported in the previous financial year |
Part 3 Division 3.2 and Schedule 3: conformity assessment procedures – Australia Therapeutic Goods (Medical Devices) Regulations 2002
17 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-medical-devices-regulations-2002::r3.11-sch3-8 | Apply the clinical evaluation procedures to every device (custom-made devices included): obtain clinical investigation data or a documented literature review, evaluate it through competent clinical experts and document the clinical evidence in writing |
| australia-therapeutic-goods-medical-devices-regulations-2002::r3.12 | Provide all records and correspondence on the application of the conformity assessment procedures in English |
| australia-therapeutic-goods-medical-devices-regulations-2002::r3.4-3.10 | Apply the conformity assessment procedures the Regulations set for the device's class (or a higher class's procedures if preferred), including the extra steps for sterile, measuring, in-house IVD and special purpose devices |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-1.3-1.4 | Full quality assurance: implement a quality management system covering design, production, packaging, labelling and final inspection, have it assessed, document it fully and build in post-market review, corrective action and notification of serious incidents and recall reasons |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-1.5-1.6 | Full quality assurance: notify and have assessed any substantial change to the system or to the devices it covers, and for Class III, Class 4 IVD and Class 4 in-house IVD devices arrange design examination before supply and for every later substantial design or performance change |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-1.7-1.9 | Full quality assurance: on request give the Secretary system documentation, design and manufacturing data and arrange tests; make a signed declaration of conformity with the clause 1.8 content; keep the clause 1.9 records for at least 5 years after the last device |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-2 | Type examination: arrange examination of a representative sample with complete design, manufacturing, standards, test, clinical and labelling documentation, supply samples on request, notify and have examined substantial design changes, and keep the records for 5 years |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-3 | Verification: have each device or a statistical batch sample examined and tested against the approved type or the technical documentation, keep production uniform, operate post-market review and notification, declare conformity and keep records |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-4 | Production quality assurance: implement and have assessed a quality management system for production and final inspection that ensures devices match the approved type or technical documentation, notify substantial changes, declare conformity and keep records |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-5 | Product quality assurance: implement and have assessed a product quality management system for final inspection and testing of each device or batch sample against the approved type or technical documentation, with post-market review, change notification, a declaration of conformity and records |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-6.3-6.4 | Declaration of conformity route: prepare and keep current technical documentation that would let the Secretary assess compliance, covering description, design drawings, sterilisation, standards, test results, connections, clinical evidence and labelling |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-6.5 | Declaration of conformity route: establish and keep up to date a post-marketing system that reviews post-production experience, applies corrective action and promptly notifies the Secretary or sponsor of serious incident information and recall reasons |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-6.6-6.7 | Declaration of conformity route: make a signed clause 6.6 declaration stating device identifiers, class, nomenclature code, any additional procedures and certificate numbers, and keep the technical file, change records and declaration for at least 5 years after the last device |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-6A | Class 1 to 3 in-house IVDs: notify the Secretary of every in-house IVD manufactured, maintain NATA (or approved body) accreditation to ISO 15189 or ISO/IEC 17025 and meet the NPAAC in-house IVD requirements, supply quality documentation and tests on request, and run a post-marketing system |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-6B | Class 4 in-house IVDs: implement a quality management system for design to final inspection, meet the blood and tissue GMP code and licence or NATA ISO 15189 accreditation with the NPAAC requirements, keep current technical documentation, run a post-marketing system, declare conformity, keep records and notify donor-screening assays for faecal microbiota transplant |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-7.2 | Custom-made devices: prepare and supply with each device a signed statement identifying the device, patient, requesting health professional and design characteristics and confirming essential principle compliance or explaining departures, keep design and production documentation, and notify serious incident and recall information |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3-7.5 | System or procedure packs: make a signed clause 7.5 declaration confirming conformity evidence for each device, registered medicines, compatible contents used within intended purposes and indications, manufacturer instructions included and documented internal control, ensure any modification leaves devices safe, run a post-marketing system and keep records |
Part 4 and Part 4A: conformity assessment certificates and Australian conformity assessment bodies – Australia Therapeutic Goods (Medical Devices) Regulations 2002
3 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-medical-devices-regulations-2002::r4.6-4.11 | Keep the certificate holder accurate: notify the Secretary within 3 months of the manufacturer's death, bankruptcy, winding up or change of name, apply within 3 months to change the name after a business disposal or amalgamation, give documentary evidence, and return superseded certificates |
| australia-therapeutic-goods-medical-devices-regulations-2002::r4A.10-4A.16 | Australian conformity assessment bodies: comply with Schedule 3AA, tell the Secretary of substantial changes within 10 working days and of planned cessation, allow entry and inspection (and bind contractors to allow it), produce information within the notice period, cooperate with reviews and keep compliance records |
| australia-therapeutic-goods-medical-devices-regulations-2002::r4A.17-4A.18 | Australian conformity assessment bodies: certify only where an appropriate procedure has been applied, vary, suspend or revoke certificates when no longer satisfied, notify the Secretary within 10 working days of refusals, suspensions, revocations, variations and significant safety concerns, notify clients of changes to the determination, agree transfers with successor bodies and check for parallel applications |
Part 5 and Part 6: inclusion in the Register and automatic conditions of inclusion – Australia Therapeutic Goods (Medical Devices) Regulations 2002
7 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-medical-devices-regulations-2002::r5.10 | Automatic condition: record complaint and adverse event information and each distribution of the device as soon as practicable and keep the records 10 years for Class III, implantable Class IIb and Class 4 IVD devices and 5 years for others |
| australia-therapeutic-goods-medical-devices-regulations-2002::r5.11 | Automatic condition: for Class III, implantable Class IIb and Class 4 IVD devices, give the Secretary an annual report before 1 October for the first three reporting periods after inclusion |
| australia-therapeutic-goods-medical-devices-regulations-2002::r5.12 | Automatic condition: for higher-risk IVDs, self-test and point-of-care IVDs and spinal fusion implants, notify the Secretary at least 20 business days before importing, supplying or exporting a device whose product name or intended purpose is not on the Register |
| australia-therapeutic-goods-medical-devices-regulations-2002::r5.13 | Automatic condition: do not supply in Australia a device containing a scheduled poison where that supply would breach Part 2 of the current Poisons Standard |
| australia-therapeutic-goods-medical-devices-regulations-2002::r5.7 | Automatic condition: report adverse events to the Secretary within 48 hours for a serious public health threat, 10 days for a death or serious deterioration, 30 days where recurrence might cause one, and otherwise within 60 days |
| australia-therapeutic-goods-medical-devices-regulations-2002::r5.8-5.8A | Automatic condition: hold and give, when required, information on any malfunction, deterioration, design, labelling, instruction or advertising inadequacy or use that led to any complaint however minor, and after a 48-hour, 10-day or 30-day report give a written follow-up report within 120 days |
| australia-therapeutic-goods-medical-devices-regulations-2002::r5.9 | Automatic condition: store and transport devices under the sponsor's control in line with the manufacturer's instructions for use and accompanying information |
Part 6A, Part 7, Schedule 3A and Schedule 4: exemptions, clinical trials, authorised supply and emergency devices – Australia Therapeutic Goods (Medical Devices) Regulations 2002
6 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-medical-devices-regulations-2002::r7.2 | Category A patients: use an unapproved device only with informed consent and at the treating medical practitioner's direction, complete the approved Category A statement, and send it to the Secretary within 28 days of use |
| australia-therapeutic-goods-medical-devices-regulations-2002::r7.3-sch4-2.3 | Clinical trials: notify the Secretary (CTN) before the device is used and before each new site starts, approve the trial on ethics committee advice no less restrictively, give National Statement assurances and information undertakings, allow inspection, follow the approved protocol, stop when the ethics committee says so, and provide safety data within 14 days of request |
| australia-therapeutic-goods-medical-devices-regulations-2002::r7.6-7.8 | Authorised prescribers: supply under an authority only as its directions allow, and when a health practitioner supplies a device under the authorised prescriber scheme notify the patient initials, condition, intended use, product, manufacturer, practitioner and practice details |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch3A | Unused emergency medical devices: when an emergency exemption ends, notify the devices on hand, store and dispose of them as the Secretary directs (destruction, export, supply or relocation) and keep disposal records |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch4-2.12-2.13 | Custom-made device exemption conditions: the manufacturer (or, for imports, the sponsor's procedures) must keep conformity or design and manufacturing information available, allow entry, inspection, testing and copying, and give the health professional's request within the period the Secretary sets |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch4-2.14-2.20 | Conditional exemptions for patient-matched devices, clinical decision support software, Class 1 to 4 in-house IVDs for specified purposes, surgical loan kits, therapeutic vaping devices, donor-screening assays and Defence use: meet each item's conditions (essential principles, conformity assessment, notices, records and information within 20 working days) |
Part 8, Part 8AA and Part 10 (regulations 10.4 and 10.4AA): information notices and adverse event reporting – Australia Therapeutic Goods (Medical Devices) Regulations 2002
2 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-medical-devices-regulations-2002::r8.1A-8.1 | Answer information notices under section 41JA within the set period and keep manufacturing records for 5 years and distribution records for 10 years (Class III and implantable Class IIb) or 5 years (others) so they can be produced |
| australia-therapeutic-goods-medical-devices-regulations-2002::r8AA | Healthcare facilities (hospitals and day hospitals): report to the TGA electronically adverse events involving Class III and Class 4 IVD devices within 10 days of a death or serious deterioration and within 45 days of a related intervention or treatment, with the facility's healthcare identifier and the event details |
Part 9A and Schedule 1 clauses 13.5, 13.6 and 13C: unique device identification – Australia Therapeutic Goods (Medical Devices) Regulations 2002
4 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-13.5-13.6 | UDI on the device: from the device's general start day provide the UDI device identifier and production identifier in human- and machine-readable form on the device, else its packaging (or outer packaging), else a leaflet or electronically for software, and put the packaging identifier on each packaging level |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-13C.1 | UDI identifiers: obtain the UDI device identifier and packaging identifiers from a single UDI issuing agency and allocate production identifiers under that agency's rules |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-13C.2-13C.4 | AusUDID entries: include each model's device identifier, issuing agency, packaging identifiers and the clause 13C.3 data elements within 30 days of first supply on or after the general start day, treat listed changes as a new model, and keep entries accurate and current |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-13C.5 | UDI direct marking: from the direct marking start day, directly mark reusable devices that are reprocessed between patients with the device and production identifiers, in both forms where practicable, unless implantable, made earlier, or marking would harm performance or is impracticable |
Schedule 1 Part 1: general essential principles (clauses 1 to 6) – Australia Therapeutic Goods (Medical Devices) Regulations 2002
6 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-1 | Essential principle 1: design and produce the device so that, used as intended by suitably trained users, it does not compromise the patient's condition or anyone's safety, and its risks are acceptable against the benefit |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-2 | Essential principle 2: choose design and construction solutions that follow safety principles and the state of the art, in the order identify hazards, design them out, protect against what remains, then tell users of residual risk |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-3 | Essential principle 3: the device must perform as the manufacturer intends and be designed, produced and packaged to suit a therapeutic purpose within the definition of a medical device |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-4 | Essential principle 4: within its stated safe-use life, under normal stresses and with maintenance and calibration done as instructed, the device must keep the safety and performance required by principles 1 to 3 |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-5 | Essential principle 5: design, produce and pack the device so that transport and storage done in line with the manufacturer's instructions do not degrade its characteristics or performance |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-6 | Essential principle 6: the benefits of using the device for its intended performance must outweigh any undesirable effects |
Schedule 1 Part 2: other essential principles (clauses 7 to 15) – Australia Therapeutic Goods (Medical Devices) Regulations 2002
19 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-10 | Essential principle 10: a device with a measuring function must measure accurately, precisely and stably within stated limits, use ergonomic scales and express results in Australian legal units or Secretary-approved units |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-11 | Essential principle 11: minimise patient, user and bystander exposure to intended and stray radiation, give users control and warnings for hazardous emissions, document radiation in the operating instructions, and control ionising radiation dose and image quality |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-12.1-a | Essential principle 12.1(1) to (4): programmed devices and software as a medical device must be safe, reliable, accurate, usable, secure and repeatable for their purpose, fail safely, warn on lost services or degraded performance, protect data integrity and privacy, follow state-of-the-art development, suit their computing platforms and state their operating requirements |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-12.1-b | Essential principle 12.1(5) and (6): build and maintain cybersecurity by best practice (protection against unauthorised access, vulnerability management, patching, disclosure and update information) and keep performance-influencing data representative, of sufficient quality, intact and managed to reduce bias |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-12.12-12.13 | Essential principles 12.12 and 12.13: devices that deliver energy or substances must set and hold the delivered rate and amount accurately, prevent accidental dangerous release, flag inadequate delivery and label controls clearly; active implants must carry a code readable without surgery identifying type, manufacturer and year |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-12.2-12.4 | Essential principles 12.2 to 12.4: where patient safety depends on power, provide a means to check an internal supply and an alarm for external power failure, and fit clinical-parameter monitors with alarms for dangerous patient states |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-12.5-12.11 | Essential principles 12.5 to 12.11: minimise electromagnetic interference with nearby equipment and protect people against electric shock, mechanical, vibration, noise, connector and surface-heat hazards |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-13.1-13.3 | Essential principles 13.1 to 13.3: provide in English, legibly and in the right place (device, packaging or leaflet), the information that identifies the device and manufacturer and explains safe use, including the clause 13.3 table items |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-13.4 | Essential principle 13.4: supply instructions for use carrying every applicable clause 13.4 table item, unless a Class I, IIa or Class 1 IVD device can be used safely without them |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-13A | Essential principle 13A: for implantable and active implantable devices in scope, make a patient implant card (or electronic equivalent) and a patient information leaflet (or electronic equivalent) available, in plain English, with the required identification, use, risk, lifetime and reporting content |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-13B | Essential principle 13B: make the current software version number and build number accessible and identifiable to users, in English |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-14 | Essential principle 14: hold clinical evidence suited to the device's use and class that demonstrates compliance with the applicable essential principles |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-15 | Essential principle 15: IVD devices must have analytical and clinical performance that supports the intended use, address accuracy, precision, sensitivity, specificity, stability, interference and measurement uncertainty, assure calibrator traceability, allow users to verify performance, and make self-tests robust and easy to use |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-7.1-7.3 | Essential principles 7.1 to 7.3: select materials for their chemical and physical properties and biocompatibility, minimise contaminants and residues, and make the device safe with the substances and medicines it contacts |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-7.4 | Essential principle 7.4: where a device incorporates a substance that would be a medicine if used alone and acts ancillary to the device, verify the substance's safety and quality as a medicine and its ancillary action for the device's purpose |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-7.5-7.7 | Essential principles 7.5 to 7.7: minimise risks from substances leaching out, from unintended ingress or egress of substances, and from released particles, with particular attention to nanomaterials |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-8.1-8.2 | Essential principles 8.1 and 8.2: eliminate or minimise infection risk, make the device easy to handle without cross-contamination, and control non-viable animal, microbial or recombinant tissues and substances with veterinary controls, origin records and validated viral inactivation |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-8.3-8.5 | Essential principles 8.3 to 8.5: supply sterile devices sterile by a validated method in controlled conditions with packaging that keeps them sterile, pack non-sterile devices to keep stated cleanliness, and label clearly which state a device is in |
| australia-therapeutic-goods-medical-devices-regulations-2002::sch1-9 | Essential principle 9: make the device safe in combination with other devices and equipment and remove or minimise physical, environmental, interference, maintenance, ageing, accuracy-loss, fire or explosion and waste disposal risks |
What is Australia Therapeutic Goods (Medical Devices) Regulations 2002 and who does it apply to?
Australia Therapeutic Goods (Medical Devices) Regulations 2002 is a compliance framework from Australia (Commonwealth) with 10 domains and 67 controls. Australia's Therapeutic Goods (Medical Devices) Regulations 2002: the essential principles, classification rules and conformity assessment procedures for medical devices and IVDs, the automatic conditions on ARTG entries (adverse event reporting periods, complaint and distribution records, annual reports), exemption and clinical trial conditions, mandatory healthcare facility reporting and the unique device identification rules. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does Australia Therapeutic Goods (Medical Devices) Regulations 2002 actually require?
Australia Therapeutic Goods (Medical Devices) Regulations 2002 has 67 controls organised across 10 domains. The largest domains are Schedule 1 Part 2: other essential principles (clauses 7 to 15) – Australia Therapeutic Goods (Medical Devices) Regulations 2002 (19 controls), Part 3 Division 3.2 and Schedule 3: conformity assessment procedures – Australia Therapeutic Goods (Medical Devices) Regulations 2002 (17 controls), Part 5 and Part 6: inclusion in the Register and automatic conditions of inclusion – Australia Therapeutic Goods (Medical Devices) Regulations 2002 (7 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of Australia Therapeutic Goods (Medical Devices) Regulations 2002 do I already cover?
Australia Therapeutic Goods (Medical Devices) Regulations 2002 does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.
How do I implement Australia Therapeutic Goods (Medical Devices) Regulations 2002?
Start your Australia Therapeutic Goods (Medical Devices) Regulations 2002 compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about Australia Therapeutic Goods (Medical Devices) Regulations 2002 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 67 controls and track your progress.
Start Your Compliance Journey
Create a free account to run self-assessments, get AI advisory, and track your compliance progress across 1,062 frameworks.
Get Started Free →Free forever, no credit card required