Updated 23 October 2026
Patient monitoring and neurology device distributors in Australia: 121 licensed establishments
The Bastion Hale Distributor Index lists 121 establishments in Australia whose registry records include patient monitoring and neurology: 16 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 62 manufacturers' own import or sales entities, 8 regulatory representatives, and 35 manufacturers or exporters, out of 745 medical device establishments in Australia overall. The records come from TGA Australia, US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 October 2026.
Entry decision: patient monitoring and neurology (MONI) in Australia
For a typical maker, from public data and the free Market Finder. Your own clearance, device class and current markets change the answer.
CE marked, shipping from the EU
Go now Rank 11 of 112 markets for this maker.
CE opens a shorter reliance route; foreign makers sell through distributors here; health spending of USD 186bn (2023, World Bank); 16 independent distributors confirmed in MONI.
High confidence: official registry with device categories and 16 independent distributors confirmed in MONI; registration route from the regulator's published rules.
FDA cleared, shipping from the US
Go now Rank 1 of 112 markets for this maker.
FDA opens a shorter reliance route; foreign makers sell through distributors here; health spending of USD 186bn (2023, World Bank); 16 independent distributors confirmed in MONI.
High confidence: official registry with device categories and 16 independent distributors confirmed in MONI; registration route from the regulator's published rules.
Registration route
With CE marking: CE opens a shorter reliance route. High confidence.
With FDA clearance: FDA opens a shorter reliance route. High confidence.
A local holder or authorised representative must hold or file the registration. Who holds the registration
TGA accepts EU notified body certificates and FDA 510(k) or PMA decisions as comparable overseas evidence; an Australian sponsor holds the ARTG entry.
Timeline and fees are not shown: no official source we cite gives them for this market yet. Confirm with a regulatory specialist before you plan a launch date. Sources: TGA, Use of market authorisation evidence from comparable overseas regulators for medical..., US Commercial Service country guide.
Sales channel
Distributor-led: Foreign makers sell through distributors here. An Australian sponsor must hold the ARTG entry and the distributor usually acts as sponsor for SMEs.
US Commercial Service country guide, published 26 May 2026.
Independent distributors in the Index: 16 for patient monitoring and neurology, 74 in Australia overall.
Makers registered here: 62 makers' own import or sales entities and 35 manufacturers.
Landed cost
Landed cost from the EU: about 10% collected at the border, under 1% real after credits (high confidence, from published tariff and tax rates). No duty, import VAT or GST about 10%.
Landed cost from the US: about 10% collected at the border, under 1% real after credits (high confidence, from published tariff and tax rates). No duty, import VAT or GST about 10%.
Tariff basket: patient monitoring and neurology. Cash is collected at clearance. Real cost is what stays after a registered distributor recovers VAT and charges. Sources: World Bank WITS TRAINS tariff API, reporter 036, MFN applied, HS6, Australian Border Force: GST and other taxes when importing.
Market size
Health spending: USD 186bn in 2023, USD 6,980 per person (World Bank).
Patient monitoring and neurology (TAM): about USD 300m to 1.5bn a year (estimate, low confidence).
For one product line sold through distributors: SAM about USD 24m to 160m, SOM about USD 170k to 1.6m a year (estimate). The free Market Finder sizes your own product range.
Broad scope, as in MedTech Europe figures: devices, diagnostics and consumables at manufacturer prices. Narrower published figures are lower.
How we estimate. At manufacturer prices.
Next step
The finder ranks every market for your own device, clearance and current markets. The CSV lists 722 establishments, the 70 independent distributors first. Company records only. 23 rows are not in the CSV and stay on their profile pages, for example names of a person or records whose only source is the Health Canada licence list.
Listed
Independent distributors only, ranked by the lines each distributor carries for other manufacturers, then registrations held, then size.
- 128 lines12 registrationssize 62.3
- 2Lateral MedicalNorman Park, QLD23 lines7 registrationssize 64.4
- 3Gytech Pty LtdArmadale, VIC17 lines9 registrationssize 52.6
- 4Intervene Medical Pty LtdPayneham, SA15 lines16 registrationssize 69.5
- 5Life Systems Medical Pty LtdSouth Melbourne VIC14 lines15 registrationssize 57.5
- 612 lines60 registrationssize 69.4
- 7The Trustee for Pacific Medical TrustMelbourne, VIC9 lines10 registrationssize 46.4
- 8THE O R COMPANY PTY LTDCheltenham Victoria, VIC3 lines35 registrationssize 80.7
- 93 lines8 registrationssize 37.9
- 102 lines7 registrationssize 34.2
- 112 lines4 registrationssize 42.7
- 122 lines3 registrationssize 33.4
- 132 lines3 registrationssize 28.6
- 142 lines2 registrationssize 34.2
- 152 lines2 registrationssize 31.2
- 162 lines2 registrationssize 31.2
Include manufacturers, their own sales entities and regulatory representatives (105)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
- 124 lines106 registrationssize 74.9
- 2Zimmer Biomet Pty LtdSydney New South Wales21 lines109 registrationssize 84.6
- 318 lines446 registrationssize 84.5
- 416 lines291 registrationssize 82.1
- 511 lines129 registrationssize 78.2
- 610 lines16 registrationssize 61.6
- 79 lines24 registrationssize 68.6
- 88 lines254 registrationssize 79.5
- 98 lines22 registrationssize 59.9
- 106 lines75 registrationssize 68.6
- 116 lines39 registrationssize 68.5
- 125 lines47 registrationssize 60.9
- 135 lines36 registrationssize 60.7
- 145 lines11 registrationssize 51.7
- 155 lines7 registrationssize 51.6
- 16Fairmont Medical Products Pty LtdDandenong South, Victoria4 lines55 registrationssize 74.4
- 174 lines28 registrationssize 68.0
- 184 lines17 registrationssize 49.7
- 194 lines16 registrationssize 49.3
- 204 lines11 registrationssize 46.0
Is your company in this list? Claim it free. No one can pay to be listed or ranked.
Patient monitoring, neurology and physical medicine covers monitors, pulse oximetry, EEG and EMG, rehabilitation and wearable devices. Registries group a wide range of risk classes here, so the counts include both hospital capital equipment houses and consumer-grade device importers. Software and connectivity now feature in many registrations.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 7 | 6% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Sponsor | 86 | 71% | Holds the market entry on behalf of a manufacturer, in markets that use that term. |
| Registration holder | 5 | 4% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 48 | 40% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 14 | 12% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Australia
In Australia the ARTG entry is held by an Australian sponsor, which is usually the importer or distributor or a local subsidiary. If the distributor is the sponsor, the market entry belongs to it until a transfer is agreed.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later. The Next 10 Markets report covers who holds the registration in each of your ten markets.
Questions about patient monitoring and neurology distributors in Australia
How many patient monitoring and neurology distributors are there in Australia?
The Index counts 121 establishments in Australia with patient monitoring and neurology in their registry record, of which 16 are independent distributors (a channel role and no manufacturing of their own). The number comes from TGA Australia, US FDA (openFDA), MHRA UK and Health Canada and was last refreshed on 23 October 2026.
Who can hold a patient monitoring and neurology device registration in Australia?
In Australia the ARTG entry is held by an Australian sponsor, which is usually the importer or distributor or a local subsidiary. If the distributor is the sponsor, the market entry belongs to it until a transfer is agreed.
How do I find a patient monitoring and neurology distributor in Australia?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Australia to see the names, free, no sign-up. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as a patient monitoring and neurology distributor in Australia?
A company that appears in a public regulatory registry with an address in Australia and whose linked device listings fall in the patient monitoring and neurology segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
How are CE-marked and FDA-cleared patient monitoring and neurology devices registered in Australia?
With CE marking: CE opens a shorter reliance route. With FDA clearance: FDA opens a shorter reliance route. A local holder or authorised representative must hold or file the registration. TGA accepts EU notified body certificates and FDA 510(k) or PMA decisions as comparable overseas evidence; an Australian sponsor holds the ARTG entry. Confirm with a regulatory specialist before you plan a launch date.
How big is the patient monitoring and neurology market in Australia?
Health spending in Australia was USD 186bn in 2023 (World Bank). Bastion Hale estimates the patient monitoring and neurology market at about USD 300m to 1.5bn a year at manufacturer prices. This is a model estimate with low confidence: health spending times the device share of health spending times the segment's share of world medical technology spending. The methodology page shows every input and source.
Other segments in Australia
Patient monitoring and neurology in other Asia Pacific markets
Sources
- Australia TGA ARTG sponsors, Australian UDI Database public download: 86 establishments, last seen 23 October 2026. Australian government public data.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 45 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 20 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 7 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 8 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.