Explore the medical device requirements currently available for Australia, organized by topic and linked to official sources.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
An ARTG variation is limited to the same kind of device; variations are made under s 9D(1) of the Act and must meet the s 41BE criteria.
Implementing a variation to an ARTG entry before the Secretary has approved it breaches a condition of inclusion in the ARTG.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Sponsor Or Local Market Entry Owner
Australian sponsor
yes
Owns ARTG Inclusion And Market Entry Obligations
May Be Same But Each Sponsor Needs Own ARTG Entry
Can Be Separate
allowed
A health professional who supplies a device to the Australian market, including by using it in clinical practice, becomes the sponsor of the device.
Sponsor Transfer By Operation Of Law Or New ARTG Inclusion
No If Transfer Notified Yes If No Transfer
Sponsorship changes by operation of law under regs 10AB, 10F and 10H of the Therapeutic Goods Regulations 1990 at the time of the triggering event (death, bankruptcy, winding up, business transfer), regardless of notification
New sponsor must notify TGA as soon as possible after the event; current official guidance states no fee and no fixed statutory window
TGA updates the ARTG entries usually within 10 working days of a complete signed notification
The transfer form cannot be used without the current sponsor's consent; third parties such as manufacturers cannot lawfully transfer sponsorship
Sponsor transfer does not transfer Manufacturer Evidence; the new sponsor must arrange appropriate manufacturer evidence
Correction: the baseline claimed a 3-month notification window; the current official page urges notification as soon as possible and states no 3-month window, no fee, and 10-working-day ARTG update.
The sponsor must meet the definition of sponsor under the Therapeutic Goods Act 1989, which requires a recognised Australian-based legal entity; sponsors are usually the Australian importer of overseas-manufactured medical devices.
Which current law, regulation, guidance, and transition provisions apply?
Therapeutic Goods Act 1989 (Commonwealth) is the primary legislation: medical devices are defined in s 41BD, and ARTG inclusion, conformity assessment certification, suspension/cancellation and s 60 reconsideration all sit under this Act, supported by the Therapeutic Goods (Medical Devices) Regulations 2002.
Is the product a device, IVD, accessory, software, or borderline product locally?
A medical device is defined in s 41BD of the Therapeutic Goods Act 1989; in vitro diagnostic (IVD) devices are medical devices whose definition is set out in the Therapeutic Goods (Medical Devices) Regulations 2002. Software and accessories meeting the definition are regulated as devices.
Which registration, notification, listing, reliance, or conformity route applies?
Unless exempt, a device must be included in the Australian Register of Therapeutic Goods (ARTG) before supply: the Australian sponsor lodges an inclusion application via TGA Business Services after acceptable Manufacturer's Evidence is in place, and TGA performs a 20-working-day preliminary assessment plus any mandatory or discretionary audit before inclusion.
Manufacturer's Evidence must be submitted to and accepted by TGA before the sponsor commences the device inclusion application; documents attached to the application are assessed in addition to that evidence.
Which foreign decisions or evidence can be reused, with what effect and conditions?
geo:aus
EU CE under MDR/IVDR
Evidence Reuse
facilitated
Product Marking
Yes
Yes
geo:aus
US FDA 510(k), De Novo, or PMA
Evidence Reuse
facilitated
Product Marketing
Yes
Yes
geo:aus
Health Canada medical-device licence
Evidence Reuse
facilitated
Product Marketing
Yes
Yes
geo:aus
Japan MHLW/PMDA Ninsho or Shonin
Evidence Reuse
facilitated
Product Marketing
Yes
Yes
geo:aus
Singapore HSA product registration
Evidence Reuse
facilitated
Product Marketing
Yes
Yes
geo:aus
Great Britain UKCA
Evidence Reuse
facilitated
Product Marketing
Yes
Yes
geo:aus
Medical Device Single Audit Program
Qms Audit Reliance
Evidence Only
Qms Audit
Yes
Yes
Which establishment licences, importer permissions, and distribution controls apply?
Every sponsor must apply to the TGA to have its imported medical devices included in the ARTG, even when another sponsor already has an ARTG entry for the same device; there is no separate importer licence regime — the sponsor's ARTG inclusion authorises import and supply.
Which evidence, local deltas, formats, and signatures are required?
Class-specific documents (per Table 2 of TGA's market authorisation evidence guidance) must be attached to the TGA application to pass preliminary assessment
Certificates issued under MRAs may no longer be acceptable for some higher-risk devices including Class III and AIMDs
Which current form, portal, account, and submission package must be used?
Applications for ARTG inclusion are lodged through the TGA Business Services (TBS) portal; the sponsor needs a Client ID and TBS access before submitting a medical device application.
Which label and IFU elements, languages, symbols, and translation controls apply?
Device information may be supplied in multiple languages, but if the device is supplied in Australia one of those languages must be English; information supplied with the device must be clear, legible and provided in English. Labelling content requirements are in Essential Principle 13 (Schedule 1, MD Regulations) and the sponsor's name and address must appear on supplied devices under Regulation 10.2.
Which QMS, audit, inspection, and certificate scope is accepted or required?
Regulatory Qms Aligned With Iso
TGA audits the manufacturer's QMS as part of Conformity Assessment against regulatory requirements and ISO 13485:2016, with on-site or desktop assessments; surveillance audits continue after certificate issue
ISO 13485 certificates alone do not create ARTG inclusion; evidence of audits by comparable overseas regulators or MDSAP auditing organisations may support an abridged desktop assessment
Rac Member Audit Reuse
What regulator fee applies to this class, route, event, and date?
An audit fee must be paid only when an application is selected for mandatory audit by law; no audit fee is payable when an application is selected for non-mandatory audit, and the audit cannot start until fees are paid.
What review, validation, and applicant stop-clock rules apply?
Statutory assessment timeframes exclude any time the TGA is waiting for the applicant to respond to a notice, letter or request for information, or to pay assessment fees; audit work cannot begin until fees are paid.
What expires, what is retained periodically, and when must renewal start?
ARTG inclusion of a kind of medical device may be cancelled under s 41GL(f) of the Act (or suspended under s 41GA(1)(b)) if the annual charge is not paid within 20 working days of it becoming payable; TGA issues invoices for all non-ACE entries each July, so inclusion is retained by paying annual charges rather than by periodic renewal.
TGA Conformity Assessment certificates are issued for a finite period and expire: manufacturers must apply for recertification of a certificate that is about to expire, lodge new applications for substantial changes, and remain subject to TGA surveillance audits while certified.
Which UDI, device listing, database, and traceability duties apply?
Unique Device Identification (UDI) requirements are mandatory for high-risk medical devices from 1 July 2026 under the Therapeutic Goods (Medical Devices) Regulations 2002, with lower-risk classes to be phased in over later years; UDI data must be submitted to the Australian UDI Database (AusUDID).
Corrects the brief's hint that UDI is 'not mandatory' — Australia's UDI system was introduced by March 2025 amendments to the MD Regulations with mandatory compliance from 1 July 2026.
Sponsors of devices that do not comply with UDI requirements must seek TGA consent to import and supply under ss 41MA and 41MAA of the Therapeutic Goods Act 1989 (Consent to Supply, CtS), lodged and approved before the applicable mandatory compliance date; the CtS application fee is AUD 80 for the first ARTG entry plus AUD 10 for each additional entry in the same application, and consent is granted for limited periods in exceptional circumstances.
Which clinical or IVD performance evidence or study is required and accepted?
Clinical evidence is required to substantiate a kind of medical device's compliance with the Essential Principles (Schedule 1 and Part 8 of Schedule 3 of the MD Regulations); clinical evaluation procedures must be applied to the device under reg 3.11(1), and TGA's Clinical evidence guidelines for medical devices set out how to compile and present the evidence.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
Unapproved medical devices may be supplied for individual patients under the Special Access Scheme: Category A (notification by a medical practitioner for seriously ill patients), Category B (prior TGA approval; processed in about 2-5 days; generally inappropriate for reusable multi-patient devices), and Category C (established-history device lists, notification); the Authorised Prescriber scheme and clinical trial schemes are alternatives.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
Records must be retained for 10 years for Class 4 IVDs, Class III and Class IIb implantable devices, or 5 years for other devices, after the last product has been distributed (s 41FO of the Act; regs 5.9, 5.10 and 8.1(b) of the MD Regulations).
Sponsors must provide annual reports for the first three years where a Class III, Class IIb implantable, or Class 4 IVD device is included in the ARTG (s 41FO(2) of the Act; reg 5.11 of the MD Regulations).
What is reportable, by whom, where, in what format, and by what deadline?
It is an automatic condition of ARTG inclusion (cl 5.7, Part 5 Div 5.2 of the MD Regulations) that sponsors report adverse events and near adverse events to the TGA via IRIS; all adverse events for devices supplied in Australia are required to be reported.
48 hours for a serious threat to public health; 10 days for death or a serious deterioration; 30 days where an event might have led to death or serious deterioration
final report within 120 calendar days of the initial report
follow-up information at least every 30 calendar days
MDIR application in TGA Business Services; only Australian events are reportable, overseas remedial actions go to the TGA recalls team
Which recall, FSCA, notice, and authority-coordination duties apply?
The Procedure for Recalls, Product Alerts and Product Corrections (PRAC) took effect on 5 March 2025 and replaced the Uniform Recall Procedure for Therapeutic Goods (URPTG); recall notifications are lodged via TGA Business Services, TGA aims to agree notifications within 7 business days, and actions are classified Class I/II/III with wholesale, hospital, retail and consumer levels, published in the DRAC database.
Corrects the brief's hint that URPTG still applies.
Which claims, audiences, channels, approvals, and restrictions apply?
Advertising of therapeutic goods (including medical devices) must comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (F2021L01661), which specifies requirements to protect the public from unethical, inaccurate or misleading advertising practices.
Advertising material for medical devices must be limited to the approved intended purpose under the ARTG inclusion, and it is an offence to advertise a device by any means for any other purpose; the claim 'TGA approved' must not be used in advertising except with explicit TGA authorisation, and restricted representations require prior approval.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
A person whose interests are affected by a reviewable initial decision may request the Minister for Health to reconsider it under s 60 of the Act (or reg 48 TG Regs 1990 / reg 10.7 MD Regs 2002); requests incur no fee and must generally be made within 90 calendar days of notice; if no decision issues within 60 days the initial decision is taken to be confirmed. Preliminary-assessment refusals and s 41FH audit-selection or s 41JA information-request decisions are not reviewable.
A person dissatisfied with a Ministerial reconsideration decision may apply to the Administrative Review Tribunal (ART) for merits review; the application must be made in writing within 28 days after the day notice of the reconsideration decision is given, subject to the Administrative Review Tribunal Act 2024.
External merits review is now conducted by the Administrative Review Tribunal (ART), which replaced the Administrative Appeals Tribunal (AAT); all cases before the AAT immediately prior to 14 October 2024 were automatically transferred to the ART.
