Australia TGA Medical Device Registration: 20 Questions on ARTG, Sponsors, Audits and Fees (2026)

Australia’s medical device market is regulated centrally by the Therapeutic Goods Administration (TGA). Market entry may appear straightforward, but the evidence requirements are exacting: devices cannot legally be supplied without inclusion in the Australian Register of Therapeutic Goods (ARTG), overseas manufacturers must rely on a local Sponsor to hold the ARTG entry, and the overseas evidence accepted by the TGA and the circumstances that trigger a mandatory audit directly affect project timelines and costs.

These 20 frequently asked questions explain Australia’s medical device regulatory framework, classification rules, Sponsor system, conformity assessment evidence, application audits, official fees for FY 2026-27 and post-market obligations, providing a practical reference for planning an Australian market-entry pathway.

1. Regulatory framework and key concepts

Q1. Which authority regulates medical devices in Australia, and what is the legal basis?

The regulator is the Therapeutic Goods Administration (TGA), which forms part of the Australian Government Department of Health and Aged Care. The core legal instruments are the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. In principle, all medical devices supplied in Australia are subject to this legislative framework.

Q2. What is the ARTG, and why is it so important?

The Australian Register of Therapeutic Goods (ARTG) is the market-authorisation database maintained by the TGA. Unless an exemption applies, a medical device must be included in the ARTG before it can legally be supplied, imported or exported in Australia. An ARTG entry has no fixed expiry date, but an annual charge must be paid to maintain it, and the entry may be cancelled if the conformity assessment evidence on which it relies ceases to be valid. In simple terms, an ARTG entry is the Australian equivalent of a registration certificate, except that the legal holder is the Sponsor rather than the manufacturer.

2. Classification, Sponsors and the registration process

Q3. How are medical devices classified in Australia?

Devices are classified by increasing risk as Class I, Class I supplied sterile, Class I with a measuring function, Class IIa, Class IIb, Class III and active implantable medical devices (AIMDs). The 22 classification rules in Schedule 2 to the Therapeutic Goods (Medical Devices) Regulations 2002 closely follow the logic of the EU Medical Devices Regulation (MDR), including rules for invasive and active devices and special rules. From 25 November 2021, Australia amended its classification rules to align them more closely with the EU MDR. Some products were upclassified, including spinal fusion implants to Class III, while rules for certain surgically invasive devices and software were also adjusted. Classification is the starting point for registration because it determines the evidence required, whether an audit is mandatory, and the applicable fees and timeline.

Q4. How are in vitro diagnostic medical devices (IVDs) classified?

IVDs have a separate classification system in Australia, with four risk levels from Class 1, the lowest, to Class 4, the highest. Class 4 covers high-risk products such as HIV and blood-grouping screening reagents; Class 3 includes most infectious disease assays; Class 2 covers moderate-risk products; and Class 1 covers low-risk products such as general reagents and instruments. IVD registration fees and audit requirements differ from those for other devices, as shown in the fee discussion below.

Q5. Can an overseas manufacturer register a product in Australia itself? What is a Sponsor?

No. An overseas manufacturer must appoint a local Australian Sponsor to hold the ARTG entry and act as the legally responsible entity. The Sponsor must be an individual who is an Australian resident, or a body corporate incorporated and carrying on business in Australia. Its role is similar to that of an EU authorised representative, but its responsibilities are greater because the Sponsor bears direct legal responsibility to the TGA.

Q6. What legal responsibilities does a Sponsor have?

The core responsibilities are: (1) holding the manufacturer’s evidence and declaration of conformity and making them available to the TGA on request; (2) ensuring that the device continues to comply with the Essential Principles; (3) reporting adverse events, as explained in Q19; (4) cooperating with recalls and corrective actions under the Uniform Recall Procedure for Therapeutic Goods (URPTG); (5) notifying the TGA within 60 days of becoming aware that an overseas certificate relied upon has been suspended, revoked or has otherwise ceased to be valid; (6) paying annual charges and managing changes to ARTG entries; and (7) cooperating with TGA audits and post-market monitoring. Choosing an unsuitable Sponsor or a Sponsor’s failure to discharge its duties can lead directly to cancellation of the ARTG entry, so the Sponsor’s competence and independence are critical.

Q7. What is the overall registration process in Australia?

The standard pathway has six steps: (1) determine whether the product is a medical device and establish its classification; (2) appoint an Australian Sponsor; (3) obtain the manufacturer’s conformity assessment evidence, comprising quality management system (QMS) certification and product evidence; (4) have the Sponsor submit and pay for an ARTG inclusion application through TGA Business Services; (5) undergo a TGA application audit if selected; and (6) obtain ARTG inclusion and lawfully place the device on the market. Annual charges and post-market regulatory obligations then apply throughout the product’s time on the market.

Q8. What is conformity assessment evidence, and which overseas evidence does the TGA recognise?

Conformity assessment is the statutory process used to demonstrate that a device complies with the Essential Principles. Since October 2018, the TGA has recognised evidence issued by comparable overseas regulators and assessment bodies (CORs), including EU notified body certificates under the MDR 2017/745 and IVDR 2017/746, as well as legacy directive certificates during applicable transition periods; the US Food and Drug Administration (FDA); Health Canada, including certificates issued by MDSAP auditing organisations; Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA); and Singapore’s Health Sciences Authority (HSA). MDSAP certification is the most widely used route for covering Australian QMS requirements. Australia is one of the five MDSAP participating countries, and an MDSAP certificate together with its audit report can be submitted directly as evidence of the manufacturer’s QMS.

3. Overseas evidence and clinical evaluation

Q9. Can FDA 510(k) clearance be used as evidence for TGA registration?

This is one of the most common misconceptions: FDA 510(k) clearance generally cannot be used on its own as conformity assessment evidence. The TGA recognises FDA premarket approval (PMA), whereas 510(k) clearance is based on substantial equivalence and does not include a complete assessment of the manufacturer’s quality system. It therefore does not meet the TGA’s manufacturer-evidence requirements. In practice, a company holding only FDA 510(k) clearance still needs QMS evidence such as MDSAP or ISO 13485 certification. This distinction must be considered when planning the evidence package, because 510(k) clearance alone does not provide an Australian registration pathway.

Q10. Can Chinese NMPA registration certificates and test reports be used directly?

A Chinese NMPA registration certificate cannot be used directly as TGA conformity assessment evidence because the NMPA is not on the TGA’s COR list. However, Chinese type-test reports, clinical data, risk management documentation and similar materials can substantively support the technical documentation when used with recognised QMS certification, such as MDSAP or ISO 13485, and product-level evidence such as CE certification or FDA PMA. In short, the conformity evidence framework must come through an accepted COR pathway, while the underlying technical and clinical data can be reused globally.

Q11. Does an EU CE (MDR) certificate provide a faster route in Australia?

Yes, and this is currently the most efficient pathway for Chinese manufacturers. A device covered by a valid EU MDR certificate can use that certificate directly as manufacturer evidence supporting an ARTG application. In addition, an MDR certificate can exempt products from a mandatory application audit in circumstances that would otherwise require one, including Class III devices, AIMDs, devices containing medicinal substances or animal- or human-derived materials, and Class 4 IVDs. This broader exemption followed the repeal of Regulation 4.1 on 28 July 2021. However, the Australian and EU classifications must correspond; although the classification rules are highly convergent, differences remain. The TGA also retains the power to conduct non-mandatory audits.

Q12. What clinical evidence is required? Can an EU CER be reused?

Essential Principle 14 requires the manufacturer to hold clinical evidence commensurate with the device’s risks to demonstrate its safety and performance. Class IIb and Class III devices and implantable devices generally require a systematic clinical evaluation report (CER). A CER prepared under the EU MDR or MEDDEV 2.7/1 Rev.4 framework can generally be reused in Australia, provided its references are mapped to the Australian Essential Principles. If a clinical trial is conducted in Australia, approval from a Human Research Ethics Committee (HREC) is required first, and the TGA must be notified or must approve the trial under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTX) scheme. The trial must also comply with the good clinical practice requirements of ISO 14155.

4. Application audits, fees and registration timelines

Q13. What is an application audit, and when is an audit mandatory?

An application audit is the TGA’s substantive review of application materials before a device is included in the ARTG. It can be triggered in two ways. A mandatory audit is required by law for high-risk circumstances, including Class III devices, AIMDs, Class 3 and Class 4 IVDs, self-testing and point-of-care IVDs, and devices containing medicinal substances or materials of animal, microbial, recombinant or human origin. A non-mandatory audit may instead be selected by the TGA on a risk basis. An important exemption applies where the product already holds a TGA or Australian conformity assessment body certificate, an EU MDR/IVDR notified body certificate, a Canadian Medical Device Licence (MDL), FDA PMA, Japanese MHLW/PMDA approval or Singapore HSA registration: the mandatory audit may be waived. This is a central benefit of obtaining CE certification or PMA before applying in Australia. Requested audit materials must be submitted within 20 working days of the TGA’s request, or the application may be refused.

Q14. What is the difference between a Level 1 and Level 2 audit?

A Level 1 audit focuses on application compliance: whether the classification is correct, which conformity assessment procedure has been applied, and whether device information such as labels and instructions for use complies with Essential Principle 13. A Level 2 audit goes beyond Level 1 into the technical documentation, including clinical evidence, the risk management report, notified body audit reports and performance verification data. Level 2 audits mainly apply to high-risk products such as Class III devices. The key to responding successfully is to have a complete, retrievable technical file when the application is submitted, rather than trying to assemble it only after selection for audit.

Q15. What are the official fees? (FY 2026-27, effective 1 July 2026)

The TGA operates on a cost-recovery basis, and fees are adjusted each financial year on 1 July. The core fees for this financial year are set out below in Australian dollars (AUD):

Application audit fees are charged separately: AUD 4,926 for a Level 1 audit and AUD 18,118 for a Level 2 audit of a Class III device. IVD audit fees are AUD 8,364 for Class 1 and Class 2 products and approximately AUD 25,350 for Class 3 and Class 4 products, although rates differ in some circumstances. If overseas evidence cannot be used and a conformity assessment certificate must instead be sought directly from the TGA, costs are substantial: a QMS assessment starts at approximately AUD 36,000 and a design examination costs approximately AUD 65,000, with timelines measured in years. This demonstrates the economic value of using accepted COR evidence. In addition, entries for devices that are no longer supplied can be declared for an annual charge exemption under the Annual Charge Exemption (ACE) Scheme, preventing inactive entries from continuing to incur annual charges.

Q16. How long does the full registration process take?

The timeline depends on the classification and whether an audit is triggered. Indicative timeframes are as follows: Class I devices that are neither sterile nor measuring follow a self-declaration pathway and can usually be included within about 1-2 weeks once the documentation is complete. Class I sterile or measuring devices and Class IIa/IIb devices usually take about 2 weeks to 1 month if not selected for audit, while a Level 1 audit can extend this to about 2-4 months. Class III devices, AIMDs and high-risk IVDs generally take about 1-3 months where MDR or other COR evidence supports an exemption from mandatory audit; if a Level 2 audit is triggered, the process typically takes 6-12 months. Documentation quality is the greatest variable. Failure to provide acceptable documents within the 20-working-day response period can jeopardise the entire application.

5. ARTG entry maintenance and post-market obligations

Q17. How many models can be included in one ARTG entry?

The ARTG is organised around the concept of a single ‘kind of medical device’. Multiple sizes and models can be grouped under one entry if they have the same Sponsor, the same manufacturer, the same classification and the same Global Medical Device Nomenclature (GMDN) term. Fees are charged per entry rather than per model. Careful planning of entry structures can therefore significantly reduce annual charges and is an important part of application strategy.

Q18. What must be done to keep an ARTG entry valid after inclusion?

Three ongoing activities are essential. First, pay the annual charge for each entry every year; overdue entries may be cancelled. Second, maintain valid evidence: MDSAP, CE and other certificates must be updated when they expire or are revoked, and the Sponsor must notify the TGA within 60 days of becoming aware that evidence relied upon has ceased to be valid. Third, manage changes: significant changes to the manufacturer, manufacturing site, device design or intended purpose must be assessed to determine whether an entry variation or a new inclusion application is required. Entry information, including GMDN terms and Unique Device Identification (UDI) information, must also remain accurate.

Q19. What are the critical post-market obligations?

Two requirements are particularly important. First, adverse event reporting deadlines: events resulting in death or serious deterioration in a person’s state of health must be reported to the TGA within 10 calendar days, while other reportable events must be reported within 30 calendar days. Second, recalls must follow the Uniform Recall Procedure for Therapeutic Goods (URPTG), including risk assessment, a communication strategy and effectiveness checks. Product advertising must also comply with the Therapeutic Goods Advertising Code, and claims must not exceed the intended purpose approved in the ARTG. The TGA also has authority to conduct post-market reviews and manufacturing-site inspections.

Q20. What recent regulatory developments are worth monitoring?

Four developments merit ongoing attention. First, classification rules were aligned more closely with the EU MDR from November 2021, upclassifying certain products and introducing reclassification transitions for existing entries. Second, reforms to software-based medical devices, including Software as a Medical Device (SaMD), took effect from February 2021, introducing software-specific classification rules and excluding or exempting some low-risk software from regulation. Third, the framework for personalised medical devices was restructured, changing the regulatory pathway for custom-made devices. Fourth, the TGA has expanded streamlined pathways using COR assessment reports, while implementation of UDI continues to be discussed. UDI was not yet mandatory in Australia at the time of publication, but early preparation is advisable. The overall direction is towards closer alignment with EU rules and greater expectations for real-world data and software transparency.

This article provides general regulatory information based on requirements current as of October 2026 and does not constitute legal or regulatory advice. Requirements, fees and transition arrangements may change; confirm the current TGA requirements for the specific device before applying.