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TGA · East Asia & Pacific

Australia medical device regulatory resources

Every Australia dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

131,192 ARTG entry records11 free resources25/25 requirements covered10 regulations trackedAug 2026 fees reviewed
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Everything we track for Australia

Medical device registration database

Search official TGA device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official TGA regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

Review current TGA application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely TGA pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent TGA policy, guidance, and compliance updates.

AI medical device classifier

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Australia requirements.

AI similar registered product finder

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Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Structured regulatory requirements

Explore all 42 source-linked facts →

25 of 25 research dimensions currently covered · 24 official sources · latest verification 2026-08-30

Market entry

D01

Authority & regime

Verified
Competent authority
Therapeutic Goods Administration (TGA), part of the Australian Government Department of Health, Disability and Ageing, is the regulator for medical devices and IVDs under the Therapeutic Go…
Penalties for supplying unapproved devices
Supplying or importing medical devices not included in the ARTG (absent an exemption) is a criminal offence carrying up to five years imprisonment and/or 5,000 penalty units (one penalty un…
2 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Primary legislation
Therapeutic Goods Act 1989 (Commonwealth) is the primary legislation: medical devices are defined in s 41BD, and ARTG inclusion, conformity assessment certification, suspension/cancellation…
1 source-linked fact
Checked 2026-08-25
Open details →
D03

Device definition & scope

Verified
Device definition
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…
1 source-linked fact
Checked 2026-08-25
Open details →
D04

Classification rules

Verified
General-device classes I, Is, Im, IIa, IIb, III and AIMD.
Class I, Class Is, Class Im, Class IIa, Class IIb, Class III, AIMD
1 maintained scheme
Checked 2026-08-25
Open details →
D05

Registration pathways

Verified
Market-access route or official registration surface
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 Servic…
Manufacturer's Evidence prerequisite
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 additio…
2 source-linked facts
Checked 2026-08-25
Open details →
D06

Reliance & recognition

Verified
EU CE under MDR/IVDR — evidence reuse
target: geo:aus · sourceApproval: EU CE under MDR/IVDR · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marking · localApplicationRequired: Yes · ta…
US FDA 510(k), De Novo, or PMA — evidence reuse
target: geo:aus · sourceApproval: US FDA 510(k), De Novo, or PMA · edgeType: evidence reuse · marketAccessStrength: facilitated · regulatoryLayer: product marketing · localApplicationRequir…
7 source-linked facts
Checked 2026-08-25
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D07

Economic-operator roles

Verified
Local market-entry role
archetype: sponsor or local market entry owner · name: Australian sponsor · required for foreign: yes · registration relation: owns ARTG inclusion and market entry obligations · importer re…
Representative or holder change
path code: sponsor transfer by operation of law or new ARTG inclusion · fresh registration: no if transfer notified yes if no transfer · timing: Sponsorship changes by operation of law unde…
3 source-linked facts
Checked 2026-08-26
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D08

Establishment, import & distribution

Verified
Each sponsor needs its own ARTG entry
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…
1 source-linked fact
Checked 2026-08-25
Open details →
D09

Dossier requirements

Verified
Documents required to pass preliminary assessment
requirement: Class specific documents (per Table 2 of TGA's market authorisation evidence guidance) must be attached to the TGA application to pass preliminary assessment · australian delta…
1 source-linked fact
Checked 2026-08-25
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D10

Official forms & portals

Verified
Submission portal and account
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.
1 source-linked fact
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
English language requirement
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 cle…
1 source-linked fact
Checked 2026-08-25
Open details →
D12

QMS, audit & inspection

Verified
QMS and audit evidence for market access
iso relation: regulatory qms aligned with iso · local regime: TGA audits the manufacturer's QMS as part of Conformity Assessment against regulatory requirements and ISO 13485:2016, with on…
1 source-linked fact
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Verified
TGA electrical/EMC evidence
Electrical safety
EESS
Adapters / components
ACMA RCM
Wireless / radio
4 maintained overlays
Checked 2026-08-29
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D14

Fees

Verified
Annual Charge - Class I (other)
AUD 121
Annual Charge - Class I (measuring/sterile)
AUD 879
11 maintained fee lines · 1 related fact
Checked 2026-08-25
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D15

Review clocks

Verified
Class I — ARTG inclusion · Inclusion in the Australian Register of Therapeutic Goods
20 working days
Class IIa — ARTG inclusion · Inclusion in the ARTG on overseas or TGA conformity assessment evidence
20 working days
Class IIb — ARTG inclusion · Inclusion in the ARTG on overseas or TGA conformity assessment evidence
20 working days
7 maintained pathways · 1 related fact
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Retention via annual charge
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 becomi…
Conformity assessment certificate expiry
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 applicatio…
2 source-linked facts
Checked 2026-08-25
Open details →

Lifecycle & post-market

D17

Change control

Verified
Change-control outcomes
outcomes: notification or administrative update; prior approval amendment or variation; new registration or new application · description: An ARTG variation is limited to the same kind of d…
New-application triggers
change creating a different kind of medical device (kind defined by unique product identifier for Class III/AIMD/Class 4 IVD and companion diagnostics, reg 1.6); change to the manufacturer'…
3 source-linked facts
Checked 2026-08-26
Open details →
D18

UDI, listing & traceability

Verified
UDI mandatory for high-risk devices
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…
Consent to Supply for non-UDI-compliant devices
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), l…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical evidence requirement
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 evalu…
1 source-linked fact
Checked 2026-08-25
Open details →
D20

Special access & derogation

Verified
Special Access Scheme for unapproved devices
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…
1 source-linked fact
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Record retention periods
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…
Annual PMS reports for high-risk devices
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…
2 source-linked facts
Checked 2026-08-25
Open details →
D22

Vigilance & incident reporting

Verified
Automatic vigilance reporting condition
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 ev…
Adverse event reporting deadlines
initial: 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: final…
2 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
PRAC recall procedure
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 notifica…
1 source-linked fact
Checked 2026-08-25
Open details →
D24

Advertising, claims & promotion

Verified
Advertising Code instrument
Advertising of therapeutic goods (including medical devices) must comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (F2021L01661), which specifies requi…
Off-label advertising offence
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 pur…
2 source-linked facts
Checked 2026-08-25
Open details →
D25

Submission communications & appeal

Verified
Ministerial reconsideration
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…
External merits review deadline
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…
3 source-linked facts
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (11 lines) →

TGA registration fees in AUD · reviewed 2026-08-25

Fee lineAmountProvenance
Annual Charge - Class I (other)AUD 121Verified
Annual Charge - Class I (measuring/sterile)AUD 879Verified
Annual Charge - Class IIa/IIbAUD 1,305Verified
Annual Charge - Class III/AIMDAUD 1,662Verified
7 more fee lines on the full schedule · 11 of 11 rows source-verified

Registration timeline

Full registration timeline →

Therapeutic Goods Administration (TGA) review clocks and planning ranges · 5-class (I, IIa, IIb, III, AIMD) classification

Class / pathwayReview clockPlanning totalProvenance
Class I — ARTG inclusion(Inclusion in the Australian Register of Therapeutic Goods)20 working days0.5-1 monthsVerified
Class IIa — ARTG inclusion(Inclusion in the ARTG on overseas or TGA conformity assessment evidence)20 working days1-1.5 monthsVerified
Class IIb — ARTG inclusion(Inclusion in the ARTG on overseas or TGA conformity assessment evidence)20 working days1.5-2 monthsVerified
Class III — ARTG inclusion(Inclusion in the ARTG on overseas or TGA conformity assessment evidence)20 working days6-9 monthsVerified
3 more pathways on the full timeline · 7 of 7 clocks source-linked
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(20 working days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Australia regulation news →

Newest official TGA headlines from the daily-refreshed feed — every row links directly to the authority publication.

Aug 12TGTGAConsultation on improving the sharing of information about medical devicesAustraliaJul 23TGTGAAdoption of International Scientific Guidelines in Australia - R01/2025AustraliaJun 30TGTGANew UDI requirements for medical devices commence 1 July 2026AustraliaMay 12TGTGAIndonesia: New halal certification requirements for medicines and medical devicesAustralia

Key regulations

All 10 Australia regulations →

Official TGA rules and guidance · 10 of 10 documents linked to official sources

Therapeutic Goods Act 1989Therapeutic Goods Act 1989
GeneralVerified
Therapeutic Goods (Medical Devices) Regulations 2002Therapeutic Goods (Medical Devices) Regulations 2002
GeneralVerified
Medical Devices Regulations 2002Therapeutic Goods (Medical Devices) Regulations 2002 - TGA Summary
GeneralVerified
ARGMDAustralian Regulatory Guidelines for Medical Devices (ARGMD)
GeneralVerified

Registry insights

Full registry statistics →

Computed from 131,192 official TGA ARTG entry records · data as of 2025-03-27

New ARTG entries by year
2019202020212022202320242025
VerifiedTGA registry · as of 2025-03-27
131,192
ARTG entries
12,017
Manufacturers
4,164
Sponsors
66
Origin countries
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Australia market-launch workpaper

Connect the TGA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

Australia dossier reuse and delta

Compare an existing authorization and evidence set against TGA administrative, testing, labeling, and dossier needs.

Australia change notification workpaper

Map a product or manufacturing change to TGA evidence, notification, timing, and implementation questions.

Australia regulatory change impact

Assess a current TGA update against one product and turn it into an owner-ready action workpaper.

Australia cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Australia (TGA).

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