HealthTech & MedTech Market Entry Playbook: TGA, Reimbursement & Digital Health in ANZ

Australia and New Zealand together represent one of the world's most accessible entry points for foreign healthtech and medical-device companies. Both markets operate universal health coverage systems — Australia's Medicare/PBS and New Zealand's ACC/public health network — which create large, government-backed procurement pipelines for validated clinical technologies. English-language documentation, common-law legal frameworks, and alignment with international regulatory standards (EU MDR, FDA, ISO 13485) mean that companies with existing market authorisation elsewhere can often leverage that work directly.

Australia's regulatory authority, the Therapeutic Goods Administration (TGA), accepts overseas conformity assessment certificates from recognised jurisdictions — EU, US, Canada, Japan, Singapore — as the basis for an abridged ARTG inclusion pathway. New Zealand takes an even lighter-touch approach, with most devices requiring only a notification to the Medsafe WAND database rather than pre-market approval. This regulatory architecture makes ANZ a comparatively efficient dual-jurisdiction launch.

The ANZ ecosystem rewards companies that solve specific system pressures: workforce shortages in rural and remote care, rising chronic disease burden, long elective surgery wait times, and the ongoing digitisation of clinical records. Foreign companies typically succeed in one of three modes:

• Medical device manufacturers (Class I–III hardware, diagnostics, implantables) seeking ARTG inclusion to access hospital and specialist procurement.
• Software-as-a-Medical-Device (SaMD) developers — clinical decision support, AI diagnostics, remote monitoring — who must navigate TGA's software classification framework before any commercial activity.
• Digital health platform vendors connecting to Australia's national My Health Record (MHR) system or NZ's health information networks, who need to demonstrate FHIR interoperability and meet data-security conformance requirements.

Irish companies such as Clanwilliam (health information software), T-Pro (clinical documentation and speech recognition), and Spectrum.Life (digital wellbeing) illustrate that ANZ markets are receptive to specialist health-software entrants from markets with comparable regulatory cultures, provided the compliance groundwork is done before launch.

The Australian Register of Therapeutic Goods (ARTG) is the national database of all therapeutic goods — medicines, medical devices, biologicals, and IVDs — that may legally be supplied in Australia. Inclusion in the ARTG is not optional: every medical device (including SaMD) must be listed or registered in the ARTG before it can be supplied, advertised, or imported for commercial use in Australia. The legal basis is the Therapeutic Goods Act 1989 (Cth), administered by the TGA.

A critical structural point for foreign companies: non-Australian entities cannot apply for ARTG inclusion directly. The Act requires an Australian Sponsor — a legal entity incorporated and based in Australia — to submit all applications via the TGA Business Services (TBS) portal, hold the ARTG entry, and carry ongoing post-market obligations. Your first market-entry decision in this sector is therefore whether to establish your own Australian subsidiary (which can then act as Sponsor) or engage a specialist third-party Sponsor.

Australia uses a risk-based classification scale directly comparable to the EU system. The four classes are:

• Class I — lowest risk (e.g., bandages, non-sterile consumables)
• Class IIa — low-to-medium risk (e.g., short-term implants, contact lenses)
• Class IIb — medium-to-high risk (e.g., ventilators, infusion pumps)
• Class III — highest risk (e.g., long-term implants, active implantable devices). Active implantable devices (formerly classified separately as AIMD) were reclassified to Class III from 25 November 2021.

Where a device has multiple functions that straddle two classes, the higher class governs. Current government ARTG application fees (one-time, per product) according to the TGA fee schedule are: Class I: AUD 621 | Class IIa & IIb: AUD 1,187 | Class III: AUD 1,530. Annual maintenance fees are: Class I (other): AUD 114 | Class IIa/IIb: AUD 1,230 | Class III/AIMD: AUD 1,566. ARTG entries do not expire but require ongoing annual fees and current conformity certificates. Fees update from 1 July each year — always verify against the current TGA fee schedule before budgeting.

Yes — and this is one of the most commercially important features of the Australian regulatory framework for foreign entrants. The Abridged Pathway allows an Australian Sponsor to rely on an overseas conformity assessment certificate in lieu of a full TGA conformity assessment, substantially reducing both cost and timeline. Accepted certificates include:

• CE Mark / EU MDR notified body certificate
• FDA 510(k) clearance or PMA approval
• MDSAP (Medical Device Single Audit Program) certificate
• PMDA (Japan), Health Canada, or HSA Singapore approvals

As a result, review timelines for lower-risk devices (Class I–IIb) via the abridged pathway typically run 4–6 weeks. Class III devices, which require more extensive technical documentation review, may take approximately 6 months. Plan for these lead times when setting commercial launch dates, and factor in time to identify and onboard your Australian Sponsor before the clock starts. Full details of the process are set out on the TGA medical device inclusion process page.

Yes, but with important carve-outs that matter to digital health product teams. Under section 41BD of the Therapeutic Goods Act 1989, Software as a Medical Device (SaMD) is regulated by the TGA as a medical device. This means that software meeting the definition of a medical device — broadly, software intended to diagnose, prevent, monitor, treat, or alleviate a disease or injury — must be included in the ARTG before it can be lawfully supplied in Australia.

However, the TGA's SaMD overview enumerates specific categories of software excluded from regulation, including:

• General wellness apps (e.g., fitness tracking without clinical claims)
• Electronic Health Record (EHR) systems used for administrative storage
• Clinical workflow management tools
• Laboratory Information Management Systems (LIMS/LIS)
• Patient survey or satisfaction tools

The TGA provides a decision tree to help developers self-classify their software. If your product falls into a grey area — for example, AI-assisted triage or remote patient monitoring with threshold alerts — err on the side of seeking a formal regulatory opinion from the TGA before launch.

Clinical Decision Support System (CDSS) software has a specific partial exemption pathway under TGA's SaMD framework. CDSS tools that present clinical information to a qualified health professional who then applies independent clinical judgement — rather than making an autonomous clinical determination — may qualify for a lower regulatory burden or exemption, depending on classification criteria.

The key variables are: (1) whether the software makes or merely informs a clinical decision; (2) the severity of the condition being managed; and (3) whether the output can directly cause harm if incorrect. AI-powered diagnostic tools that generate outputs acted on without independent review typically sit in Class IIa or higher. Developers building in this space should review the TGA's AI and software guidance carefully and consider engaging a regulatory consultant experienced with ANZ SaMD submissions. Companies such as T-Pro — whose clinical documentation platform uses speech recognition and AI to generate clinical notes — navigate exactly this boundary between workflow tool and regulated SaMD.

Whether in Australia or New Zealand, the primary quality management and software lifecycle standards expected for regulated health software are:

• ISO 13485:2016 — Medical devices quality management system. Your Australian Sponsor will require evidence of ISO 13485 certification as part of the conformity documentation package.
• IEC 62304:2006+AMD1:2015 — Medical device software lifecycle processes. This standard is explicitly referenced by Medsafe (NZ) as applicable for software-based devices notified to the WAND database.
• ISO 14971 — Risk management for medical devices, covering hazard identification, risk estimation, and risk control.
• IEC 82304-1 — Health software product safety (specifically for standalone software products not embedded in hardware).

If you have already obtained CE Mark under EU MDR using these standards, your technical documentation will substantially satisfy both TGA abridged pathway requirements and Medsafe's expectation of applicable standards compliance.

Australia operates three parallel reimbursement mechanisms, each with its own advisory committee and evidence requirements. All three ultimately advise the Minister for Health. Understanding which pathway applies to your product is the first reimbursement strategy decision:

• Medicare Benefits Schedule (MBS) — funds health professional services, including services that use specific medical technologies or procedures. The Medical Services Advisory Committee (MSAC) assesses applications for new MBS items. If your device is used within a clinical service that could attract a new or modified MBS item, MSAC is your pathway.
• Pharmaceutical Benefits Scheme (PBS) — funds listed medicines. The Pharmaceutical Benefits Advisory Committee (PBAC) assesses applications. If your product is a pharmaceutical or biologic, PBS listing via the PBAC is the primary reimbursement route.
• Prescribed List (PL) for medical devices — funds specific medical devices and human tissue products within the public health system. The Medical Devices and Human Tissue Advisory Committee (MDHTAC) assesses applications for PL listing.

All three mechanisms are described on the Department of Health's health technology assessment page. An ARTG inclusion is a prerequisite for any government reimbursement application — reimbursement and regulatory approval are separate but sequential processes.

PBS listing applications are submitted to the Pharmaceutical Benefits Advisory Committee (PBAC) via the Department of Health. The process involves three core phases: (1) a clinical assessment comparing the applicant's product against the therapeutic standard of care; (2) an economic evaluation (cost-effectiveness analysis) demonstrating value for money against an agreed comparator; and (3) public consultation before the PBAC makes a recommendation to the Minister. If the PBAC recommends listing, price negotiations with the Department follow before the product appears on the PBS.

PBS timelines depend on submission completeness, the complexity of the clinical evidence, and whether the PBAC requests a major re-submission. Budget for 12–24 months from first submission to listing as a working assumption; contested or novel technologies may take longer. Engage a health economics firm with PBAC submission experience early in your ANZ market-entry planning — typically 18–24 months before your target reimbursement date.

Yes. Several bridging mechanisms exist for companies with strong clinical evidence but no formal listing yet:

• Private hospital formulary listing — many private hospital groups maintain their own device and consumables formularies. A listing here creates revenue while a public reimbursement submission progresses.
• MBS-funded services using existing items — if a clinician can use your technology within a service that already has an MBS item (e.g., a diagnostic imaging item), private billing is possible without a new item, subject to clinical appropriateness.
• Prostheses List (PL) interim funding requests — MDHTAC can consider provisional or interim funding arrangements in specific circumstances.
• Private health insurance product listing — private health insurers can fund devices not yet on the PL on an extras or ancillary basis, particularly for Class I–IIa devices.

None of these are substitutes for formal government reimbursement, but they allow commercial operations and real-world evidence generation that strengthens subsequent submissions to MSAC, PBAC, or MDHTAC.

My Health Record (MHR) is Australia's national opt-out personal electronic health record system, operated by the Australian Digital Health Agency (ADHA) under the My Health Records Act 2012. The ADHA was established specifically to lead Australia's national digital health strategy and sets the technical standards, manages the MHR platform, and drives interoperability across public and private health systems.

Connection to MHR is mandatory for certain healthcare provider organisations — hospitals, general practices, specialists, pathology laboratories, and diagnostic imaging providers that participate in Medicare. If your platform serves these provider types and you want it to integrate with patients' longitudinal health records, MHR connectivity is a market expectation and often a procurement requirement. In 2024, the ADHA went to market for a FHIR server solution with the contract estimated at AUD 45–50 million, signalling the scale of the government's investment in MHR modernisation.

Vendors connecting to MHR must register as developers through the ADHA and comply with a defined technical conformance stack. The key requirements are:

• FHIR (HL7 Fast Healthcare Interoperability Resources) is the mandatory interoperability standard. Since 2022, the ADHA has worked with HL7 Australia to drive FHIR adoption across the health system.
• FHIR Gateway registration — all new MHR-connecting systems must onboard via the ADHA FHIR Gateway.
• EP-4232:2026 conformance specification — vendors must implement and demonstrate compliance with the current ADHA conformance specification for MHR-connecting systems.
• Security Requirements for MHR Connecting Systems — a separate security standard covering authentication, authorisation, audit logging, and data handling for systems that read or write to MHR.

Plan a minimum of 6–12 months for the full developer registration, conformance testing, and go-live process. Irish health information software companies such as Clanwilliam, which supply GP and specialist practice management systems to ANZ markets, are well-positioned for MHR integration given existing FHIR experience from European deployments. If your product already speaks FHIR R4, the adaptation effort is primarily in meeting ADHA's AU-specific implementation guides rather than rebuilding core integration architecture.

New Zealand's approach to medical device regulation is markedly lighter than Australia's and is one of the most important differentiators when planning a dual-market ANZ launch. Medsafe — the New Zealand Medicines and Medical Devices Safety Authority, a business unit of the Ministry of Health — does not operate a pre-market approval process for most medical devices. There is no NZ equivalent of the ARTG inclusion requirement.

Instead, the responsible sponsor must notify the device to the Web Assisted Notification of Devices (WAND) database within 30 calendar days of becoming the device's sponsor. WAND registration is free with no ongoing annual fees. Medsafe then relies on post-market surveillance to identify safety issues rather than pre-market review. Sponsors must ensure devices comply with applicable standards (ISO 13485, IEC 62304 for software) but do not need to submit a full conformity assessment dossier to Medsafe at the point of notification.

The practical implication: a company with ARTG inclusion in Australia can notify its NZ WAND entry and begin legal supply in New Zealand in a matter of days, making NZ an efficient companion market to any Australian launch.

Pharmac (Te Pātaka Whaioranga) is the NZ government agency responsible for deciding which medicines and some medical devices are funded on behalf of the New Zealand public health system. Unlike Australia's separate MSAC/PBAC/MDHTAC structure, Pharmac is a single decision-maker covering both pharmaceuticals and certain devices.

To seek Pharmac funding, applicants submit an evidence package including clinical and health economic data. Pharmac's Factors for Consideration framework — available on the Pharmac funding process page — guides prioritisation across nine criteria, including health need, clinical benefit, cost-effectiveness, budget impact, and equity. There is no fixed statutory timeframe for a decision; the average time from application to a funded decision has historically been approximately 36 months (Pharmac-reported).

In 2024, the New Zealand Government allocated an additional NZD 604 million over four years to Pharmac, enabling the funding of 66 new medicines — a signal of political commitment to improving access and reducing application backlogs. Budget and timeline assumptions should be verified with a NZ regulatory affairs adviser given the dynamic funding environment.

Yes — and you should. One of the most commercially valuable features of the NZ regulatory system is that Pharmac's funding assessment process can run concurrently with Medsafe's quality, safety, and efficacy assessment. According to Pharmac's guidance, sponsors do not need to wait for Medsafe regulatory approval before lodging a Pharmac funding application. Running both processes in parallel can shave 12–18 months off the total time to first funded patient access, which is material given the 36-month average decision timeline.

Practical sequencing for a NZ market entry: (1) Notify WAND within 30 days of appointment as sponsor — this is a legal requirement and is fast; (2) Simultaneously lodge a Pharmac pre-submission meeting request to understand the evidence package requirements; (3) Prepare and submit the full Pharmac application while Medsafe quality review proceeds; (4) Maintain active communication with both agencies throughout. A NZ regulatory affairs specialist who understands both Medsafe's standards expectations and Pharmac's Factors for Consideration framework is a high-value early hire or retainer for any company serious about NZ funded access.

Use this checklist to structure your Australian regulatory and commercial preparation. Work through it with your regulatory affairs adviser and legal counsel before committing to launch dates.

• ☐ Determine your device's TGA classification (Class I / IIa / IIb / III) using the TGA classification guidance and, if SaMD, the TGA software decision tree
• ☐ Confirm whether your software is regulated SaMD or falls within an excluded category (general wellness, EHR, LIMS, workflow tool) per the TGA SaMD overview
• ☐ Identify and appoint an Australian Sponsor (subsidiary or third-party) — no ARTG application can proceed without one
• ☐ Confirm which overseas conformity certificates you hold (CE Mark, FDA, MDSAP, etc.) to qualify for the Abridged Pathway
• ☐ Prepare or update your ISO 13485 quality management documentation and IEC 62304 software lifecycle records
• ☐ Lodge ARTG inclusion application via the TGA Business Services (TBS) portal
• ☐ Budget ARTG application fees (Class I: AUD 621 | Class IIa/IIb: AUD 1,187 | Class III: AUD 1,530) and annual maintenance fees per the current TGA fee schedule
• ☐ Identify target reimbursement pathway (MBS/MSAC, PBS/PBAC, or Prescribed List/MDHTAC) and initiate pre-submission meeting with the relevant advisory committee
• ☐ If connecting to My Health Record: register as an ADHA developer, review EP-4232:2026 conformance spec, and plan FHIR Gateway integration
• ☐ Engage a health economics firm to begin Australian reimbursement submission preparation (allow 18–24 months lead time)

New Zealand's lighter-touch regime allows faster initial entry, but funded access still requires sustained effort. This checklist covers both the regulatory notification and the Pharmac funding track.

• ☐ Appoint a NZ responsible sponsor and notify the device to the Medsafe WAND database within 30 calendar days of appointment (no fee)
• ☐ Confirm your device complies with applicable standards — ISO 13485 for QMS, IEC 62304 for software — as expected by Medsafe
• ☐ Request a pre-submission meeting with Pharmac to scope your evidence package requirements and understand Factors for Consideration priorities
• ☐ Initiate concurrent Pharmac application — do not wait for Medsafe quality assessment to complete before lodging, per Pharmac's guidance
• ☐ Prepare NZ-specific health economic model (Pharmac uses its own HTA framework, separate from PBAC requirements)
• ☐ Identify NZ distributor or clinical champion network to support real-world evidence generation during the ~36-month Pharmac review period
• ☐ Consider private hospital and ACC (Accident Compensation Corporation) pathways as bridge revenue while Pharmac funding is pending
• ☐ Monitor Pharmac's published Factors for Consideration updates and any new government funding announcements (the 2024 NZD 604 million allocation shows the funding environment is active)

They are separate processes, but the documentation base largely overlaps. For Australia, you need ARTG inclusion via the TGA — a formal application supported by your conformity assessment documentation, ISO 13485 certificate, and (for the abridged pathway) your overseas regulatory certificate. For New Zealand, you notify the Medsafe WAND database — a much lighter process that draws on the same underlying technical documentation but does not require a formal submission review.

In practice, companies structure their ANZ regulatory programme as: (1) compile the full technical file for TGA; (2) run TGA ARTG application; (3) simultaneously or immediately after, complete the WAND notification using the same technical documentation base. The incremental effort for NZ over Australia is modest once the Australian documentation is in order.

No. The Therapeutic Goods Act 1989 requires the Sponsor to be an Australian-based legal entity. A foreign company cannot sponsor its own devices from overseas. The two practical options are:

• Establish an Australian subsidiary (Pty Ltd), which then acts as Sponsor. This gives full control over the ARTG entry, post-market obligations, and commercial relationships but involves incorporation costs, compliance obligations, and management overhead.
• Engage a third-party Sponsor — specialist regulatory affairs firms and distribution partners in Australia offer Sponsorship services on a fee or equity basis. This is faster initially but creates dependency and requires a robust contractual arrangement covering liability, data ownership, and transition rights if you later establish your own entity.

Most foreign companies scaling meaningfully in Australia transition from a third-party Sponsor to their own subsidiary within 12–24 months of commercial launch. Factor this transition cost and effort into your market-entry plan from the outset. The TGA's guidance on the medical device inclusion process covers Sponsor obligations in detail.

MHR is the most prominent national integration, but the Australian digital health landscape includes several other systems and standards relevant depending on your product type:

• Electronic Prescribing — the national electronic prescribing network (eRx and MediSecure historically; now consolidating under ADHA's electronic prescribing service) is relevant for any prescribing or pharmacy platform.
• HL7 FHIR AU Implementation Guides — the Australian Digital Health Agency and HL7 Australia maintain AU-specific FHIR implementation guides covering patient, practitioner, medication, and diagnostic data structures that differ from base FHIR in important ways.
• HIE (Health Information Exchanges) at state level — several state health departments (NSW Health, Queensland Health, Victorian DHHS) operate their own clinical integration networks and procurement portals for digital health vendors.
• Medicare Online integration — any platform processing Medicare claims or PBS prescriptions needs to integrate with Services Australia's Health Professional Online Services (HPOS) infrastructure.

Mapping which of these integrations your product needs for its target clinical workflow is an essential part of your technical architecture review before committing to a development roadmap for Australia.

Timeline varies significantly by device class and reimbursement strategy. Here are realistic working assumptions based on the regulatory facts above:

• Class I device, private market, no reimbursement: ARTG inclusion 4–6 weeks (abridged pathway) + Sponsor setup 4–8 weeks = approximately 3–4 months to first legal supply. NZ WAND notification can run in parallel, adding minimal time.
• Class IIa/IIb SaMD, private market: Classification confirmation + ARTG abridged application + Sponsor setup = approximately 4–6 months. FHIR/MHR integration adds 6–12 months if required.
• Class III device or novel SaMD, full TGA review: Allow 9–12 months for ARTG inclusion plus Sponsor setup.
• Government reimbursement (PBS/MSAC/Pharmac): Add 18–36+ months from first ARTG inclusion to funded listing, on top of the above.

The fastest path to ANZ revenue is almost always a Class I or Class IIa product with an existing EU or FDA clearance, sold initially to private hospitals or specialist clinics on a direct-pay basis while government reimbursement applications progress. This is the proven entry playbook for foreign medtech companies and is consistent with the approach taken by health software entrants such as Clanwilliam and Spectrum.Life in their ANZ expansions.