Updated 22 October 2026
Medical device distributors in Australia: 202 licensed establishments
The Bastion Hale Distributor Index lists 202 medical device establishments registered with an address in Australia: 10 with a channel role (importer, distributor, wholesaler or authorised representative), 29 registration holders without a channel role, and 163 registered as manufacturer or exporter only. The records come from US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
By segment
Segments come from the device listings linked to each establishment, so one company can appear in several rows. Imaging and radiology are shown because the registries contain them.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 10 | 5% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 31 | 15% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 175 | 87% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 50 | 25% | 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 it per market.
Top 20 establishments by size
Channel roles (importer, distributor, wholesaler, authorised representative) are listed first, then registration holders, then manufacturers. Size is a 0 to 100 score built from products listed, registrations held, roles, sources and principals represented. Complete is 0 to 5 for website, address, segments, principals and counts.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | THE O R COMPANY PTY LTD Cheltenham Victoria, VIC | Channel Distributor, Registration holder, Manufacturer, Exporter | Gastroenterology, urology and OB/GYN, Patient monitoring and neurology, Surgery and endoscopy | 12 | 7 | 0 | 41.0 | 3/5 |
| 2 | ASIGA PTY LTD. Alexandria New South Wales, NSW | Channel Distributor, Registration holder, Manufacturer | Dental | 6 | 4 | 0 | 34.4 | 3/5 |
| 3 | ERSKINE DENTAL MACKSVILLE New South Wales | Channel Distributor, Manufacturer, Exporter | Dental, Ophthalmic | 12 | 1 | 0 | 29.8 | 3/5 |
| 4 | HISMILE PTY LTD BURLEIGH WATERS Queensland | Channel Distributor, Manufacturer, Exporter | Dental | 6 | 1 | 0 | 26.7 | 3/5 |
| 5 | Buzz Products Pty Ltd Abbotsford Victoria | Channel Distributor, Exporter | Dental, Ear, nose and throat | 3 | 1 | 0 | 22.2 | 3/5 |
| 6 | RED CORAL ACUPUNCTURE SUPPLIES Melbourne Victoria | Channel Distributor, Exporter | General hospital and consumables | 3 | 1 | 0 | 22.2 | 3/5 |
| 7 | ALMITAS GROUP INTERNATIONAL PTY LTD Richmond Victoria | Channel Distributor | Surgery and endoscopy | 1 | 1 | 0 | 16.5 | 3/5 |
| 8 | Scolicare Pty Ltd Bda Scolicare Kogarah, New South Wales | Channel Distributor, Manufacturer | No segment in record | 0 | 1 | 0 | 15.2 | 2/5 |
| 9 | Eshopping Group Pty Ltd. Welshpool, Western Australia | Channel Distributor | No segment in record | 0 | 1 | 0 | 12.9 | 2/5 |
| 10 | Substance Pty Ltd Collingwood, Victoria | Channel Distributor | No segment in record | 0 | 1 | 0 | 12.9 | 2/5 |
| 11 | RESMED PTY LIMITED BELLA VISTA New South Wales, NSW | Holder Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +1 more | 213 | 77 | 0 | 63.1 | 3/5 |
| 12 | COCHLEAR LIMITED LANE COVE New South Wales, NSW | Holder Registration holder, Manufacturer, Exporter | General hospital and consumables, Ear, nose and throat, Patient monitoring and neurology +2 more | 166 | 23 | 0 | 57.8 | 3/5 |
| 13 | SDI LIMITED BAYSWATER Victoria, VIC | Holder Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental | 78 | 18 | 0 | 51.3 | 3/5 |
| 14 | COMPUMEDICS LIMITED Melbourne Victoria, VIC | Holder Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Patient monitoring and neurology | 45 | 11 | 0 | 48.0 | 3/5 |
| 15 | MYOFUNCTIONAL RESEARCH CORP. PTY. LTD. HELENSVALE Queensland, QLD | Holder Registration holder, Manufacturer, Exporter | Dental | 25 | 6 | 0 | 42.6 | 3/5 |
| 16 | Ellex Medical Pty Ltd Mawson Lakes South Australia, SA | Holder Registration holder, Manufacturer | Ophthalmic, Imaging, radiology and radiotherapy, Surgery and endoscopy | 15 | 9 | 0 | 40.2 | 3/5 |
| 17 | LEICA BIOSYSTEMS MELBOURNE PTY LTD. MELBOURNE Victoria, VIC | Holder Registration holder, Manufacturer | In-vitro diagnostics | 16 | 6 | 0 | 38.9 | 3/5 |
| 18 | CARE ESSENTIALS PTY LTD. North Geelong Victoria, VIC | Holder Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Orthopaedics, spine and trauma +1 more | 31 | 2 | 0 | 38.1 | 3/5 |
| 19 | WILLIAM A. COOK AUSTRALIA, PTY. LTD. EIGHT MILE PLAINS Queensland | Holder Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Ear, nose and throat +2 more | 12 | 6 | 0 | 37.5 | 3/5 |
| 20 | 4DMEDICAL LIMITED Carlton Victoria, VIC | Holder Registration holder, Manufacturer | Imaging, radiology and radiotherapy | 9 | 7 | 0 | 36.8 | 3/5 |
Questions about medical device distributors in Australia
How many medical device distributors are there in Australia?
The Index counts 202 medical device establishments registered in Australia, of which 10 hold a channel role as importer, distributor, wholesaler or authorised representative. The rest are registration holders or manufacturers. The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a medical 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 medical device distributor in Australia?
Start with the segment table on this page, open the top establishments and check their roles, principals and registration counts. Then search the Index for your device and Australia to see the counts for your segment and reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a distributor in Australia?
An establishment is a company that appears in a public regulatory registry with an address in Australia, in any of the roles importer, distributor, wholesaler, authorised representative, sponsor, registration holder, manufacturer or exporter. Each company is counted once per country even if it holds several licences or appears in several registries. No contacts or named individuals are collected.
Segment pages for Australia
Related markets in Asia Pacific
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 189 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 44 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.