Australia TGA Medical Device Registration & ARTG Consulting
Navigate Australia's Therapeutic Goods Administration requirements with confidence. NexorTest provides end-to-end TGA medical device registration, ARTG inclusion, and Australian Sponsor services to get your devices to market faster.
TGA Medical Device Risk Classes
The TGA classifies medical devices into ascending risk categories. Understanding your device classification is the critical first step toward ARTG inclusion.
Class I / I(s) / I(m)
General non-invasive devices, including sterile (I(s)) and measuring (I(m)) variants. Lowest regulatory burden with manufacturer self-assessment.
- ⏰ ~4 weeks to ARTG listing
Class IIa
Short-term invasive devices, diagnostic devices, and devices that interact with the body in a limited manner. Requires third-party conformity assessment.
- ⏰ ~4 weeks to ARTG listing
Class IIb
Long-term invasive devices and implants with moderate risk profiles. More stringent conformity assessment and clinical evidence requirements.
- ⏰ ~6 weeks to ARTG listing
Class III / AIMD
Life-sustaining implants and Active Implantable Medical Devices. Requires full TGA conformity assessment with comprehensive clinical data review.
- ⏰ ~6 months to ARTG listing
Comprehensive TGA Consulting Services
From initial classification to post-market compliance, NexorTest delivers the full spectrum of TGA regulatory consulting services across Australia and New Zealand.
TGA ARTG Inclusion
End-to-end management of your ARTG inclusion application, from documentation preparation through submission and TGA liaison to successful listing of your medical device.
Australian Sponsor Services
Full Australian Sponsor representation for international manufacturers. We act as your in-country legal entity, managing all TGA obligations and post-market responsibilities.
TGA Classification
Expert device classification under TGA rules, ensuring correct risk categorization and identification of the appropriate conformity assessment pathway for your device.
Conformity Assessment
Navigation of TGA conformity assessment procedures, including Essential Principles compliance, quality system evidence, and coordination with TGA-recognized bodies.
Technical Documentation TGA
Preparation and review of complete technical files meeting TGA requirements, including risk management, clinical evidence, biocompatibility, and Essential Principles checklists.
IVD Registration TGA
Specialized In Vitro Diagnostic device registration with TGA, covering IVD classification, performance evaluation, analytical and clinical evidence, and ARTG inclusion.
SaMD TGA Registration
Software as a Medical Device regulatory strategy and TGA registration, including SaMD classification, clinical evaluation of algorithms, and cybersecurity documentation.
Post-Market Reporting Australia
Ongoing post-market surveillance, adverse event reporting to TGA, periodic safety updates, and field safety corrective actions to maintain ARTG compliance.
NZ Medsafe Registration
Medical device registration with New Zealand's Medsafe regulatory authority, leveraging TGA documentation to streamline dual-market access across Australia and New Zealand.
Why NexorTest for TGA Registration
Our dedicated Australia-New Zealand regulatory team combines deep TGA expertise with practical market access strategies.
TGA-Specialist Regulatory Team
Our consultants have direct TGA submission experience across all device classes, understanding the nuances of Australian regulatory requirements that generalist consultancies miss.
Fast-Track Submission Process
Our proven submission templates and established TGA relationships enable faster application processing, with Class I/IIa listings achieved in as little as 4 weeks.
98% First-Time Approval Rate
Our thorough pre-submission reviews and quality-first approach delivers industry-leading first-time approval rates, avoiding costly rejections and re-submissions.
In-Country Sponsor Capability
Unlike many consultancies, we offer direct Australian Sponsor services, eliminating the need for you to find a separate sponsor entity and streamlining your market entry.
AU + NZ Dual-Market Access
Leverage our expertise in both TGA and Medsafe to achieve simultaneous market entry across Australia and New Zealand, maximizing your Oceania market opportunity.
Full Lifecycle Compliance
Beyond initial registration, we provide ongoing ARTG maintenance, annual fee management, adverse event reporting, and certificate renewal services to keep your listing active.
Your Path to ARTG Listing
Our proven 6-step methodology takes your device from initial assessment to successful ARTG inclusion with predictable timelines and full transparency.
Device Classification & TGA Strategy
Determine TGA device classification, applicable Essential Principles, and develop a tailored regulatory strategy for ARTG inclusion.
Australian Sponsor Appointmen
Establish the required Australian Sponsor arrangement, whether through your own entity or NexorTest’s sponsor services for international manufacturers.
Conformity Assessment & Testing
Complete all required conformity assessment procedures, coordinate testing, and compile evidence against TGA Essential Principles requirements.
ARTG Application Submission
Prepare and submit the complete ARTG inclusion application package through the TGA Business Services portal with all supporting documentation.
TGA Review & Approval
Manage TGA review interactions, respond to any information requests or deficiency notices, and guide the application through to approval.
ARTG Listing & Post-Market Compliance
Secure your ARTG listing and establish ongoing post-market surveillance, adverse event reporting, and annual compliance management systems.
TGA Registration Across All Device Sectors
Our TGA consulting experience spans the complete range of medical device categories registered in Australia.
- 🏥 Cardiovascular Devices
- 🦴 Orthopaedic Implants
- 🔬 In Vitro Diagnostics (IVD)
- 💻 Software as Medical Device (SaMD)
- 🧬 Dental Devices
- 👁 Ophthalmic Devices
- 🩺 Patient Monitoring Systems
- 💉 Drug Delivery Devices
- 🧠 Neurological Devices
- ❤ Wound Care Products
- 🏋 Rehabilitation Equipment
- 💡 AI/ML-Based Medical Devices
- 🩸 Blood Bank Equipment
- 📊 Imaging & Radiology Devices
- 🧪 Laboratory Instruments
- 🛡 Sterilization Equipment
TGA Registration FAQs
Common questions about TGA medical device registration and ARTG inclusion in Australia.
What is TGA ARTG registration?
TGA ARTG registration is the process of including a medical device on the Australian Register of Therapeutic Goods (ARTG), administered by the Therapeutic Goods Administration (TGA) under Australia’s Department of Health. All medical devices must be included in the ARTG before they can be legally supplied in Australia. The process involves device classification, appointing an Australian Sponsor, completing conformity assessment, and submitting an application to the TGA for review and approval.
What are TGA device classes?
TGA classifies medical devices into ascending risk categories: Class I (lowest risk), Class I sterile, Class I measuring, Class IIa, Class IIb, Class III, and Active Implantable Medical Devices (AIMD, highest risk). The classification determines the regulatory pathway, conformity assessment requirements, and level of evidence needed for ARTG inclusion. Higher-risk devices require more rigorous assessment procedures and longer review timelines.
What is an Australian Sponsor?
An Australian Sponsor is a mandatory requirement for ARTG inclusion. The sponsor must be an Australian-based entity (individual or company resident in Australia) who takes legal responsibility for the medical device in the Australian market. The sponsor is responsible for applying for ARTG inclusion, maintaining the listing, adverse event reporting, and ensuring ongoing compliance. Foreign manufacturers must appoint an Australian Sponsor to market their devices in Australia.
How long does TGA registration take?
TGA registration timelines vary by device classification. Class I and Class IIa devices typically take approximately 4 weeks for ARTG inclusion. Class IIb devices generally require around 6 weeks. Class III and AIMD devices, being the highest risk categories, can take approximately 6 months due to the more detailed TGA assessment process. These timelines assume complete documentation and may extend if the TGA requests additional information.
What documents are needed for TGA registration?
TGA registration requires comprehensive documentation including: device description and specifications, classification justification, Essential Principles checklist, risk management files (ISO 14971), clinical evidence and evaluation, quality management system certification (ISO 13485), labelling and IFU compliant with TGA requirements, Australian Sponsor details, conformity assessment evidence, and applicable test reports. IVDs and SaMD have additional specific documentation requirements.
Does ARTG listing expire?
ARTG listings themselves do not expire, but they require annual fees to maintain the listing active. Additionally, all supporting certificates (such as ISO 13485 QMS certification and conformity assessment certificates) must remain current and valid. If supporting certificates lapse or annual fees are not paid, the ARTG listing may be cancelled. Sponsors must also maintain ongoing post-market surveillance and reporting obligations to keep their listings in good standing.
What about New Zealand Medsafe?
Medsafe is New Zealand’s equivalent of Australia’s TGA and regulates medical devices under the Medicines Act. While Australia and New Zealand have historically had mutual recognition arrangements, each country maintains its own regulatory requirements. NexorTest provides registration services for both TGA (Australia) and Medsafe (New Zealand), helping manufacturers navigate both regulatory systems efficiently, often leveraging documentation prepared for one jurisdiction to streamline the other.
Can NexorTest provide sponsor services?
Yes, NexorTest provides comprehensive Australian Sponsor services for international medical device manufacturers seeking to enter the Australian market. Our sponsor services include acting as your legal Australian Sponsor for ARTG inclusion, managing the entire application process, handling adverse event reporting obligations, maintaining ARTG listing compliance, liaising with the TGA on your behalf, and managing annual renewals and post-market requirements. This eliminates the need for you to establish an Australian entity.
Ready to Enter the Australian Market?
Get a free TGA pathway assessment from our regulatory specialists. We will map out your fastest route to ARTG inclusion.
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