Australia TGA ARTG Inclusion & Australian Sponsor Services
Your Partner for Successful Market Access in Australia
End-to-end regulatory, technical and compliance support for Medical Devices, IVDs and Software as Medical Devices to achieve TGA compliance, ARTG inclusion and long-term market access in Australia.
Deep TGA Regulatory Expertise
Specialized team with extensive TGA experience
High Approval Success Rate
Proven strategies for faster market access
Australian Sponsor You Can Rely On
Full compliance with ongoing Sponsor obligations
Global Perspective, Local Execution
International experience with local Australia focus
Strong Lab Network
Access to NATA-accredited testing laboratories
End-to-End Support
From strategy to ongoing compliance
Our Australia Regulatory Services
1. Australia Regulatory Strategy & Classification
- •Determine correct GMDN term and classification
- •Classify under the right risk class: I, Is, Im, IIa, IIb, III
- •Regulatory pathway assessment & roadmap
2. ARTG Inclusion & Application Support
- •Prepare and submit ARTG inclusion applications
- •Justify 'kind of medical device'
- •Respond to TGA audit & information requests
3. Australian Sponsor Services
- •Provision of compliant Australian Sponsor
- •Ongoing Sponsor obligations & governance
- •Change management & licence maintenance
4. Technical Documentation & Essential Principles
- •Review against Schedule 3 (Essential Principles)
- •Technical File gap assessment & remediation
- •IMDRF ToC structure alignment
5. Testing Strategy & Laboratory Coordination
- •Test plan development based on risk & device type
- •Coordination with NATA-accredited labs
- •Test report review & acceptability assessment
6. TGA Application Audit & Submission Support
- •Application dossier review before submission
- •TGA audit readiness & mock audit
- •Information request management
7. IVD Market Access & Performance Evidence
- •IVD classification (Class 1 to Class 4)
- •Analytical & clinical performance studies
- •Performance evaluation report (PER) support
8. SaMD / Software & Cybersecurity Compliance
- •SaMD classification (MD vs IVDMD)
- •IEC 62304, ISO 14971 & ISO 27001 alignment
- •Cybersecurity risk management & SBOM
9. Post-Market Surveillance & Vigilance (IRIS)
- •PMS plan development
- •Incident reporting in IRIS database
- •Field safety corrective actions (FSCA)
10. Labelling, IFU & Advertising Compliance
- •Australian labelling requirements
- •IFU in English (and other required languages)
- •Advertising compliance under TGA guidelines
11. Manufacturer, Importer & Supply Chain Compliance
- •Manufacturer obligations under the Act
- •Australian importer requirements
- •Distributor & supply chain compliance
12. Change Management & Variations
- •Assess impact of changes on ARTG inclusion
- •Submit variations (if required)
- •Update technical docs, labelling & IFU
Our End-to-End Australia Regulatory Process
Strategy & Qualification
Confirm regulatory status, intended purpose, classification, UDI horizon and market-access pathway.
Conformity & Evidence
Determine acceptable TGA or comparable overseas evidence and establish the Manufacturer Evidence strategy.
Technical Evidence & Testing
Assess Essential Principles, risk, technical documentation, clinical/performance evidence and lab testing gaps.
Sponsor & ARTG Application
Establish Sponsor readiness, GMDN/kind-of-device strategy, Manufacturer Evidence linkage and submit ARTG inclusion.
TGA Review / Audit
Respond to audit or information requests with structured evidence and regulatory rationale.
UDI, PMS & Lifecycle
Maintain UDI / AusUDID, vigilance, annual reporting where applicable, market actions, variations and change control.
Australian Medical Device Licensing Pathways
(Low Risk)
- • Self-assessment by manufacturer
- • ARTG inclusion (No Conformity Assessment for Class I non-sterile non-measuring)
(Low-Moderate Risk)
- • Conformity Assessment by a TGA-recognised CAB or overseas regulator
- • Manufacturer Evidence + ARTG inclusion
(Moderate-High / High Risk)
- • Conformity Assessment by a TGA-recognised CAB or overseas body
- • Manufacturer Evidence + ARTG inclusion
(Risk-Based IVD Rules)
- • Risk-based approach (Class 1 to 4)
- • Manufacturer Evidence + ARTG inclusion
About TGA
The Therapeutic Goods Administration (TGA) regulates medical devices under the Therapeutic Goods Act 1989 and associated regulations. ARTG is the public register of medical devices included in Australia.
tga.gov.auAustralian Sponsor Obligations
- • Must be an Australian-based legal entity
- • Responsible for compliance with all sponsor obligations
- • Ensure devices comply with the Act and Regulations
- • Maintain records and make them available to TGA
Post-Market Obligations
- • Maintain a PMS system
- • Report incidents in IRIS (10/30 days)
- • Annual Report (for higher risk devices)
- • Conduct trend analysis & CAPA
- • Support TGA recalls and FSCA
Key Timelines
Serious Incident: Report to TGA within 10 days
Other Incident: Report to TGA within 30 days
TGA May Audit Your Application
TGA may select applications for audit. Ensure your dossier is complete, accurate and audit-ready to avoid delays.
Why Choose NKB Regovanta for Australia?
Ready to Bring Your Device to Australia?
Partner with our Australia regulatory experts to achieve TGA compliance and ARTG inclusion with confidence.
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Success in Australia
Comprehensive Australia Regulatory & TGA Compliance
Explore our in-depth methodologies, strategic frameworks, and regulatory decision pathways for the Australian market.
1. Australia Regulatory Strategy & Product Classification
Classification is not an administrative label. It drives the minimum conformity evidence, ARTG pathway, application-audit exposure, UDI timing and post-market obligations. NKB Regovanta reviews the intended purpose and the device characteristics that actually trigger the Australian classification rules before the market-access plan is fixed.
When This Support Is Needed
- • Launching a new device or IVD in Australia
- • Changing intended purpose, indications, duration of use, anatomical site or user population
- • Adding software functionality or converting a hardware feature into software
- • Introducing sterile, measuring, implantable or active functionality
- • Using an overseas classification as the starting point and needing to confirm whether Australian rules produce the same outcome
- • Building a multi-market product family where Australian grouping and evidence must be aligned early
Our Support Includes
- • Product qualification as a medical device, IVD, software-based medical device or other therapeutic good
- • Intended purpose and claims review
- • Class I, Is, Im, IIa, IIb and III classification strategy for non-IVD medical devices
- • IVD Class 1, 2, 3 and 4 classification strategy under the risk-based IVD rules
- • Accessory, system and procedure pack considerations
- • Software / SaMD classification and exemption / exclusion assessment
- • GMDN term and “kind of medical device” assessment
- • Conformity assessment route determination & initial UDI timing
Senior Regulatory Question:
If the intended purpose changes, does the classification still hold — and does the existing conformity evidence still cover the Australian kind of device?
2. Manufacturer Evidence & Conformity Assessment Strategy
Manufacturer Evidence is a core gate in the Australian pathway. For most device and IVD applications, the Sponsor must hold an accepted Manufacturer Evidence identifier before the ARTG application can proceed. The evidence must be current, applicable to the manufacturer and appropriate for the risk class and product scope.
When This Support Is Needed
- • Preparing a first Australian ARTG application
- • Using EU, UK, US, Canadian or other overseas regulatory evidence to support Australia
- • Changing certification body, conformity assessment certificate, manufacturing site or legal manufacturer
- • Transitioning from older EU certificates to MDR / IVDR certificates
- • Extending a product family or adding models under existing evidence
- • Responding to a TGA question about the adequacy or scope of manufacturer evidence
Our Support Includes
- • Review of TGA Conformity Assessment Certificates where applicable
- • Review of acceptable comparable overseas regulator / assessment body evidence
- • Manufacturer Evidence application and variation strategy
- • QMS certificate and product-assessment evidence review
- • Declaration of Conformity review
- • Certificate scope, device family and classification alignment
- • Manufacturer legal name and site consistency
- • Strategy for certificate lapse, replacement or variation
Senior Regulatory Question:
Can the Sponsor demonstrate, document by document, that the conformity assessment evidence applies to the same manufacturer, same device scope and same intended purpose being represented in Australia?
3. ARTG Inclusion Strategy & Application Preparation
ARTG inclusion is not a simple product-by-product registration. The application is built around the Australian concept of a “kind of medical device”, with classification, GMDN, manufacturer, conformity assessment evidence and grouping logic determining how devices are represented in the ARTG.
Our Support Includes
- • ARTG inclusion pathway assessment
- • Kind-of-device and grouping strategy
- • GMDN assessment
- • Manufacturer and Sponsor data alignment
- • Manufacturer Evidence linkage review
- • Declaration of Conformity review
- • Intended purpose and classification consistency review
- • TGA Business Services application support & post-inclusion quality check
What We Challenge Before Submission
- • Grouping products that do not meet the same kind-of-device criteria
- • GMDN term that does not accurately represent intended purpose or technology
- • Mismatch between ARTG application and Declaration of Conformity
- • Manufacturer Evidence identifier that does not cover the proposed class / scope
- • Claims or model information in Australian labelling that exceed the ARTG regulatory basis
Senior Regulatory Question:
If TGA asks for the Declaration of Conformity, conformity evidence and technical dossier today, will every document support the same device scope represented by the ARTG application?
4. Australian Sponsor Services & Regulatory Governance
A foreign manufacturer needs an Australian-based Sponsor to interface with the TGA and hold the ARTG inclusion. The Sponsor role is regulatory and ongoing: it requires access to technical and safety information, control of regulatory communications, vigilance readiness and the ability to act when the manufacturer changes the device or a safety issue emerges.
Our Support Includes
- • Pre-market Sponsor readiness and ARTG coordination
- • Manufacturer–Sponsor regulatory responsibilities
- • Access to technical, clinical, performance and safety information
- • Conditions of inclusion monitoring
- • TGA information / sample request coordination
- • Complaint and adverse-event escalation
- • Medical Device Incident Reporting (MDIR) coordination
- • Recall / product alert / product correction support under PRAC
- • UDI / AusUDID responsibilities and data maintenance
What We Challenge Before Submission
- • Manufacturer informs the Sponsor only after a change has already been implemented
- • Sponsor cannot access current technical or post-market records
- • Complaints reach distributors but not the Sponsor
- • Overseas recall or regulator action is not assessed for Australian impact
- • UDI, ARTG, labelling and technical-file changes are managed in separate silos
Senior Regulatory Question:
Could the Sponsor independently demonstrate to TGA why the device remains compliant, what changed, what incidents occurred and what corrective actions were taken?
Frequently Asked Questions (Australia & TGA)
Key questions manufacturers ask when entering and maintaining medical devices on the Australian market.
Do all medical devices need ARTG inclusion before supply in Australia?
Most medical devices and IVDs must be included in the ARTG before lawful supply unless a valid exemption, exclusion or other specific pathway applies. Regulatory status should be confirmed before commercial supply.
Does a foreign manufacturer need an Australian Sponsor?
Yes. The Sponsor applying for ARTG inclusion must be an Australian-based legal entity and must maintain the regulatory interface with the TGA and the manufacturer.
What is Manufacturer Evidence?
Manufacturer Evidence is accepted conformity assessment evidence linked to the manufacturer and used to support ARTG inclusion. For most medical device and IVD applications, the Sponsor needs an accepted Manufacturer Evidence identifier before the ARTG application can proceed.
Can EU, UK, US or other overseas regulatory evidence be used in Australia?
Australia recognises certain evidence from comparable overseas regulators and assessment bodies. Whether it can support the Australian application depends on the device, risk class, evidence source, scope, intended purpose and current TGA requirements.
Can an ARTG application be audited by TGA?
Yes. TGA may select medical device and IVD applications for audit. The Sponsor may need to provide technical, clinical, performance, risk, labelling and conformity evidence before inclusion.
When does Australian UDI apply?
UDI is being implemented in phases. Mandatory requirements began for Class III and Class IIb devices on 1 July 2026, with later dates for other classes. Each portfolio should be assessed against the current TGA implementation timetable and any transitional provisions.
What are the sponsor adverse-event reporting timelines?
For sponsors, serious threats to public health are generally reportable within 48 hours, events that led to death or serious deterioration within 10 days, and events whose recurrence might lead to death or serious deterioration within 30 days.
Which devices require annual reports after ARTG inclusion?
Certain higher-risk devices — including implantable Class IIb devices, Class III devices and Class 4 IVDs — have annual-reporting obligations for the first three years of inclusion, subject to the applicable regulatory conditions.
Can NKB Regovanta coordinate testing laboratories?
Yes. Where external testing is required, we can help define the regulatory testing strategy, coordinate with established laboratories, review protocols and assess final reports for use in the Australian regulatory evidence package.
Does an existing CE certificate automatically mean the device can be sold in Australia?
No. Overseas evidence may be useful and, where accepted, can support Australian market authorisation. The Sponsor must still confirm Australian classification, acceptable evidence, Manufacturer Evidence requirements, ARTG inclusion, labelling and ongoing Sponsor obligations.
What happens if the device changes after ARTG inclusion?
The change should be assessed for impact on conformity evidence, Manufacturer Evidence, ARTG representation, UDI, labelling and post-market obligations. Depending on the change, a variation, new inclusion, additional validation or other regulatory action may be needed.
Is Australian UDI the same as US FDA UDI or EU MDR UDI?
Australia recognises aspects of global UDI implementation, but Australian UDI requirements and AusUDID data obligations must still be assessed separately. Existing identifiers may be reusable in some circumstances, but Australian compliance should not be assumed automatically.
Your Regulatory Partner for Australian Market Access
Whether you are classifying a new device, validating overseas conformity evidence, preparing Manufacturer Evidence, applying for ARTG inclusion, appointing an Australian Sponsor, planning laboratory testing, preparing for TGA audit, implementing UDI or strengthening post-market compliance, NKB Regovanta supports the regulatory lifecycle from strategy through ongoing market maintenance.