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Australia Therapeutic Goods Act 1989
Australia (Commonwealth)
vCompilation No. 89 (C2025C00525), compilation date 5 September 2025, registered 18 September 2025, incorporating amendments up to Act No. 38, 2025
8 domains
38 controls
Australia's Therapeutic Goods Act 1989, built around medical devices, sponsor obligations and advertising: ARTG inclusion and certification, automatic and imposed conditions, conformity assessment, adverse event, tampering and medicine shortage reporting, recalls, manufacturing licences, advertising controls, counterfeit goods and the offences, civil penalties and executive officer liability that enforce them.
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Australia Therapeutic Goods Act 1989 is a compliance framework from Australia (Commonwealth) with 8 domains and 38 controls. The largest domains are Chapter 3: sponsor duties for medicines and other therapeutic goods (standards, registration and listing, conditions, adverse effects, recalls, shortages, manufacturing) – Australia Therapeutic Goods Act 1989 (8 controls), Chapter 4A and Chapter 5: vaping goods, advertising and generic information, counterfeit goods and product tampering – Australia Therapeutic Goods Act 1989 (8 controls), Chapter 4 Part 4-11: offences and civil penalty provisions relating to medical devices – Australia Therapeutic Goods Act 1989 (7 controls). Every control below carries what it requires and what an assessor expects to see.
Maintained by Gerard Blokdyk
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Framework Domains (8)
Chapter 3: sponsor duties for medicines and other therapeutic goods (standards, registration and listing, conditions, adverse effects, recalls, shortages, manufacturing) – Australia Therapeutic Goods Act 1989
8 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-act-1989::s14-14A | Do not import, supply or export therapeutic goods that fail an applicable standard (other than labelling or packaging) without the Secretary's written consent, and comply with any consent conditions |
| australia-therapeutic-goods-act-1989::s19B-21 | Deal only in therapeutic goods that are registered or listed in relation to you, exempt, or covered by a section 19 or 19A approval, notify the Secretary of every manufacturer and manufacturing premises before dealing, and supply wholesale only goods that are registered, listed, exempt or approved |
| australia-therapeutic-goods-act-1989::s22 | Never print a false registration or listing number, never advertise goods for an indication not accepted for their ARTG entry, and comply with the conditions of exemptions, approvals and authorities |
| australia-therapeutic-goods-act-1989::s28 | Comply with every condition of registration or listing: the ministerial determination of standard conditions and any conditions the Secretary imposes on inclusion or later by notice |
| australia-therapeutic-goods-act-1989::s29A-29AA | As soon as you become aware of it, tell the Secretary in writing of information that contradicts information already given, shows a possible unintended harmful effect or reduced effectiveness in recommended use, or indicates unacceptable quality, safety or efficacy |
| australia-therapeutic-goods-act-1989::s30EA-30EC | Comply with every recall and public notification requirement the Secretary imposes on non-conforming goods: recall distributed goods, inform the public or specified classes, publish manufacturing or distribution information and tell the Secretary who received the goods |
| australia-therapeutic-goods-act-1989::s30EF-30EG | For reportable medicines, notify the Secretary of a shortage within 2 working days if it has critical impact or otherwise within 10 working days, and of a decision to discontinue supply permanently 12 months ahead (critical impact) or 6 months ahead |
| australia-therapeutic-goods-act-1989::s35-40 | Carry out manufacturing steps for human-use goods in Australia only under a licence covering that step and site, observe the manufacturing principles and applicable standards, report adverse quality information, and allow inspection, questioning and document and sample production |
Chapter 4 Part 4-11: offences and civil penalty provisions relating to medical devices – Australia Therapeutic Goods Act 1989
7 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-act-1989::s41MA-41MD | Do not import, supply or export a medical device that fails the essential principles (other than labelling) without the Secretary's consent, apply for consent with the fee, and comply with every condition of a consent |
| australia-therapeutic-goods-act-1989::s41ME-41MG | Manufacturers must not supply, and sponsors must not import, export or supply, a device to which the conformity assessment procedures have not been applied, unless the gap is covered by a conformity assessment standard or overseas regulator evidence is in force |
| australia-therapeutic-goods-act-1989::s41MH | Make no false or misleading statement in a declaration of conformity or related statement about applying conformity assessment procedures or comparable requirements to a device you manufacture |
| australia-therapeutic-goods-act-1989::s41MI-41MK | Import, export, supply or manufacture a medical device in Australia only if it is included in the Register in relation to you or is covered by an emergency exemption, an exempt device, a section 41HB approval, a section 41HC authority or your section 41HD approval, and supply wholesale only such devices |
| australia-therapeutic-goods-act-1989::s41ML-41MLB | Do not advertise an included device for a purpose not accepted for its ARTG inclusion, and never falsely represent that a device is on the Register, exempt, approved or authorised |
| australia-therapeutic-goods-act-1989::s41MP-41MPB | Give the Secretary, within the regulation periods, information on malfunctions, design, labelling, instruction or advertising inadequacies or use that might lead or have led to death or serious deterioration, recall reasons, essential principle non-compliance and restricted, suspended or revoked supporting certificates |
| australia-therapeutic-goods-act-1989::s41MQ-41MR | If an ARTG device application is withdrawn or lapses and the Secretary asks within 10 working days, say in writing within 20 working days whether you know of adverse event information and give it, accurately |
Chapter 4 Parts 4-1 to 4-4A: medical device interpretation, essential principles, conformity assessment and certificates – Australia Therapeutic Goods Act 1989
3 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-act-1989::s41EB-41EI | Conformity assessment certificate applications: apply on the approved form with the fee, give no false or misleading information, and allow the Secretary's inspection of manufacturing premises, equipment, processes and facilities (including overseas) when required |
| australia-therapeutic-goods-act-1989::s41EJ | Conformity assessment certificate holders: allow entry, inspection, testing, sampling and recording at any premises dealing with covered devices, produce documents on the devices and quality system, cooperate with reviews, notify planned substantial changes in writing and pay review fees |
| australia-therapeutic-goods-act-1989::s41EWD | Australian conformity assessment bodies: keep the certification records their determination requires for as long as they are a body and for 15 years after ceasing to be one |
Chapter 4 Parts 4-5 and 4-6: including medical devices in the Register, conditions, suspension and cancellation – Australia Therapeutic Goods Act 1989
5 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-act-1989::s41FC-41FE | ARTG applications for medical devices: give no false or misleading information and certify accurately that the products are medical devices with a specified purpose, correctly classified, compliant with the essential principles, conformity-assessed, advertised lawfully and free of prohibited substances |
| australia-therapeutic-goods-act-1989::s41FN-1-2 | Automatic ARTG conditions: let authorised persons enter, inspect, test, sample and record at any premises (including overseas) where the devices are dealt with, produce and allow copying of device documents, and deliver a reasonable number of samples within at least 10 working days of request |
| australia-therapeutic-goods-act-1989::s41FN-3 | Automatic ARTG conditions: always hold, or be able to obtain from the manufacturer within 20 working days, the essential principle evidence, conformity assessment evidence and information on changes to the device, product range or quality system; give it to the Secretary on request; report adverse events within the prescribed periods; and pass relevant information back to the manufacturer |
| australia-therapeutic-goods-act-1989::s41FN-5 | Automatic ARTG condition: keep all advertising material for the device consistent with the intended purpose certified in the ARTG application |
| australia-therapeutic-goods-act-1989::s41FO-41FP-41MN | Comply with conditions the Secretary imposes on an ARTG device entry (manufacture, custody, purpose, supply, disposal, records including post-supply tracking, extra essential principle matters) and with prescribed and ministerial conditions, because any breach is an offence and civil penalty |
Chapter 4 Parts 4-6A and 4-7: emergency exemptions, exempt devices, approvals and authorities – Australia Therapeutic Goods Act 1989
2 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-act-1989::s41GS-41GY | Emergency exemptions: deal in exempted devices only within the conditions the Minister specifies (quantity, source, persons, supply and stockpile use, storage and security, UDI, records, disposal) and dispose of unused devices as the regulations require |
| australia-therapeutic-goods-act-1989::s41HA-41HD-41MO | Exempt devices, special access, clinical trial, authorised prescriber and shortage approvals: deal under each exemption, approval or authority only within its conditions, use experimental devices only under the prescribed conditions, and notify supplies under prescriber rules within 28 days |
Chapter 4 Parts 4-8 to 4-10: information, mandatory healthcare facility reporting, recall and fees – Australia Therapeutic Goods Act 1989
3 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-act-1989::s41JA-41JJ | Information notices: give the Secretary the information or documents demanded about compliance, conformity assessment, conditions, advertising, supply, prohibitions, safety and efficacy or overseas regulatory history within the period set (at least 10 working days), in the form required, and never give false or misleading information |
| australia-therapeutic-goods-act-1989::s41JM | Healthcare facilities: the chief executive must report to the Secretary any death or serious deterioration from use of a reportable device in the facility, any averted use that would likely have caused one, and any treatment for a serious deterioration caused by such a device, unless already reported to the Commission or the State health department |
| australia-therapeutic-goods-act-1989::s41KA-41KC | Comply with recall and public notification requirements for devices that fail the essential principles, were not conformity assessed or breach prohibitions: recall distributed devices, inform the public or specified classes, publish manufacturing or distribution information and tell the Secretary who was supplied |
Chapter 4A and Chapter 5: vaping goods, advertising and generic information, counterfeit goods and product tampering – Australia Therapeutic Goods Act 1989
8 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-act-1989::s42DD-42DK | Use a restricted representation (a reference to a serious form of a disease or condition identified in the Code) only with an approval or permission, include every required representation, use prohibited representations only with the Secretary's written permission, and keep to any conditions |
| australia-therapeutic-goods-act-1989::s42DL-42DLC | Do not advertise therapeutic goods with unapproved prohibited or restricted representations, without required representations, with references to the Act, with implied government endorsement, or referring to Schedule 3, 4 or 8 substances, biologicals or prescribed unregistered goods, and obey any notice banning a false representation |
| australia-therapeutic-goods-act-1989::s42DM-42DMA | Make every public advertisement for therapeutic goods comply with the Therapeutic Goods Advertising Code, noting each day of continuing non-compliance is a separate contravention |
| australia-therapeutic-goods-act-1989::s42DN-42DQ | When disseminating generic information about ingredients or components of therapeutic goods to the public, comply with the Advertising Code provisions prescribed for generic information |
| australia-therapeutic-goods-act-1989::s42DR-42DX | Answer the Secretary's advertising or generic information substantiation notices within the period set (at least 14 days) and comply with directions to cease, retract, correct, recover or destroy advertisements or stop a claim |
| australia-therapeutic-goods-act-1989::s42E-42F | Never manufacture, supply, import or export counterfeit therapeutic goods, meaning goods whose label, presentation, records or advertising falsely represent their identity, composition, ingredients, strength, size, sponsor, source, manufacturer or place of manufacture |
| australia-therapeutic-goods-act-1989::s42T-42U | Notify the Secretary within 24 hours of becoming aware of actual or potential tampering, or a substantial risk of it, with any therapeutic goods you supply, manufacture or sponsor, and within 24 hours of receiving any information or demand about tampering |
| australia-therapeutic-goods-act-1989::s42V-42W | Comply with tampering recall and public notification requirements, and do not supply or export goods of a kind or batch subject to a tampering recall without the Secretary's written consent |
Chapters 5A, 6 and 7: enforcement, administration, charges, scheduling and executive officer liability – Australia Therapeutic Goods Act 1989
2 controls
| Code | Title |
|---|---|
| australia-therapeutic-goods-act-1989::s43-44 | Pay the annual charges for ARTG entries and other charges when they fall due, because unpaid charges are recoverable and non-payment can cancel an entry |
| australia-therapeutic-goods-act-1989::s54B-54BA | Executive officers who know a listed offence or a civil penalty contravention by their company will occur, and can influence its conduct, must take all reasonable steps to prevent it or become personally liable |
What is Australia Therapeutic Goods Act 1989 and who does it apply to?
Australia Therapeutic Goods Act 1989 is a compliance framework from Australia (Commonwealth) with 8 domains and 38 controls. Australia's Therapeutic Goods Act 1989, built around medical devices, sponsor obligations and advertising: ARTG inclusion and certification, automatic and imposed conditions, conformity assessment, adverse event, tampering and medicine shortage reporting, recalls, manufacturing licences, advertising controls, counterfeit goods and the offences, civil penalties and executive officer liability that enforce them. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does Australia Therapeutic Goods Act 1989 actually require?
Australia Therapeutic Goods Act 1989 has 38 controls organised across 8 domains. The largest domains are Chapter 3: sponsor duties for medicines and other therapeutic goods (standards, registration and listing, conditions, adverse effects, recalls, shortages, manufacturing) – Australia Therapeutic Goods Act 1989 (8 controls), Chapter 4A and Chapter 5: vaping goods, advertising and generic information, counterfeit goods and product tampering – Australia Therapeutic Goods Act 1989 (8 controls), Chapter 4 Part 4-11: offences and civil penalty provisions relating to medical devices – Australia Therapeutic Goods Act 1989 (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 Act 1989 do I already cover?
Australia Therapeutic Goods Act 1989 does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.
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