Updated 25 October 2026
Who holds medical device registrations in Australia
The sponsor applies to include the device in the Australian Register of Therapeutic Goods (ARTG). The Index lists 521 TGA sponsors in Australia from the TGA Australia register, last read on 23 October 2026.
Medical device companies in Australia: distributors, importers and makers
General information, not legal advice. Local law varies; take local counsel.
Who may hold a registration in Australia
The sponsor applies to include the device in the Australian Register of Therapeutic Goods (ARTG). It must be an Australian resident, or a body incorporated in Australia that carries on business there.
The list comes from the Australian UDI Database, which holds only the devices whose sponsors have submitted UDI data, so it is a subset of the ARTG and the count is a minimum.
Sources: TGA, The role of the sponsor.
TGA sponsors in Australia: top 50
Ranked by active ARTG entries. Each name opens its profile with roles, principals and sources.
- 1446 registrationsMaker's own entity
- 2291 registrationsMaker's own entity
- 3285 registrationsRegulatory representative
- 4256 registrationsMaker's own entity
- 5254 registrationsMaker's own entity
- 6215 registrationsMaker's own entity
- 7157 registrationsMaker's own entity
- 8137 registrationsMaker's own entity
- 9Device Technologies Australia Pty LtdMedindie South Australia131 registrationsDistributor
- 10129 registrationsMaker's own entity
- 11Zimmer Biomet Pty LtdSydney New South Wales108 registrationsMaker's own entity
- 12106 registrationsMaker's own entity
- 1398 registrationsMaker's own entity
- 1494 registrationsMaker's own entity
- 1589 registrationsMaker's own entity
- 1684 registrationsDistributor
- 17Arthrex Australia Pty Ltd.Frenchs Forest New South Wales82 registrationsMaker's own entity
- 1877 registrationsRegulatory representative
- 1975 registrationsMaker's own entity
- 20COCHLEAR LIMITEDLane Cove New South Wales, NSW68 registrationsMaker's own entity
- 2166 registrationsMaker's own entity
- 2261 registrationsMaker's own entity
- 2360 registrationsDistributor
- 24Endotherapeutics Pty LtdMacquarie Park NSW59 registrationsDistributor
- 2559 registrationsMaker's own entity
- 2658 registrationsMaker's own entity
- 2754 registrationsRegulatory representative
- 2852 registrationsMaker's own entity
- 2952 registrationsMaker's own entity
- 30WILLIAM A. COOK AUSTRALIA, PTY. LTD.Eight Mile Plains Queensland, Qld51 registrationsMaker's own entity
- 31Fairmont Medical Products Pty LtdDandenong South, Victoria51 registrationsMaker's own entity
- 32Merit Medical Australia Pty Ltd.Braiside Victoria48 registrationsMaker's own entity
- 3347 registrationsMaker's own entity
- 3447 registrationsMaker's own entity
- 3547 registrationsMaker's own entity
- 3647 registrationsMaker's own entity
- 3747 registrationsMaker's own entity
- 38SIGNATURE ORTHOPAEDICS PTY LIMITEDSydney New South Wales46 registrationsMaker's own entity
- 3946 registrationsMaker's own entity
- 4045 registrationsMaker's own entity
- 4143 registrationsMaker's own entity
- 4240 registrationsDistributor
- 4339 registrationsMaker's own entity
- 4439 registrationsMaker's own entity
- 4537 registrationsMaker's own entity
- 4636 registrationsMaker's own entity
- 4735 registrationsMaker's own entity
- 4835 registrationsMaker's own entity
- 4934 registrationsMaker's own entity
- 5034 registrationsMaker's own entity
Download all 520 company rows as CSV
Company level only: names that are only a person's name are left out.
How many holders also distribute
70 of the 521 holders listed here (13%) are also independent distributors in the Index: companies that supply the market for makers other than themselves, not a manufacturer, a maker's own entity or a regulatory service firm.
The others: 348 makers' own import or sales entities and 103 regulatory representatives that hold registrations with no sign in the registries that they supply the market.
Holders that also distribute in Australia: top 20
- 1Device Technologies Australia Pty LtdMedindie South Australia131 registrationsDistributor
- 284 registrationsDistributor
- 360 registrationsDistributor
- 4Endotherapeutics Pty LtdMacquarie Park NSW59 registrationsDistributor
- 540 registrationsDistributor
- 633 registrationsDistributor
- 730 registrationsDistributor
- 8THE O R COMPANY PTY LTDCheltenham, Victoria28 registrationsDistributor
- 924 registrationsDistributor
- 1022 registrationsDistributor
- 1120 registrationsDistributor
- 1218 registrationsDistributor
- 1318 registrationsDistributor
- 1417 registrationsDistributor
- 15Intervene Medical Pty LtdPayneham, SA16 registrationsDistributor
- 16Akva SurgicalPort Melbourne, VIC16 registrationsDistributor
- 17Life Systems Medical Pty LtdSouth Melbourne VIC15 registrationsDistributor
- 1815 registrationsDistributor
- 19Ebos Medical Devices Australia Pty LtdNorth Ryde, NSW13 registrationsDistributor
- 2012 registrationsDistributor
See every independent distributor in Australia on the country page.
Independent holders in Australia: top 20
Companies that hold registrations here with no sign in the registries that they supply the market themselves: regulatory representatives and holders as a service. A holder that is not your distributor keeps your distributors replaceable. Confirm what each one does before you appoint it.
- 1285 registrationsRegulatory representative
- 277 registrationsRegulatory representative
- 354 registrationsRegulatory representative
- 427 registrationsRegulatory representative
- 525 registrationsRegulatory representative
- 620 registrationsRegulatory representative
- 719 registrationsRegulatory representative
- 817 registrationsRegulatory representative
- 917 registrationsRegulatory representative
- 1014 registrationsRegulatory representative
- 1113 registrationsRegulatory representative
- 1212 registrationsRegulatory representative
- 1312 registrationsRegulatory representative
- 1410 registrationsRegulatory representative
- 1510 registrationsRegulatory representative
- 169 registrationsRegulatory representative
- 176 registrationsRegulatory representative
- 186 registrationsRegulatory representative
- 195 registrationsRegulatory representative
- 205 registrationsRegulatory representative
Medical device registration in Australia with CE or FDA clearance
With CE marking or FDA clearance: Either one opens a shorter reliance route.
TGA accepts EU notified body certificates and FDA 510(k) or PMA decisions as comparable overseas evidence; an Australian sponsor holds the ARTG entry.
Sources: TGA, Use of market authorisation evidence from comparable overseas regulators for medical devices (v2.1, May 2026), US International Trade Administration, Country Commercial Guide: Australia medical devices. Confidence in this route: high, checked 23 October 2026. Rules change and differ by device class; confirm with the regulator before you plan a launch date.
How to check it yourself in the official register
TGA, Australian Register of Therapeutic Goods (ARTG) search. Search by sponsor name to see the ARTG entries that sponsor holds.
The register is the record that counts. Check the holder named on your own device's registration before you sign, and again before you change distributors.
What changes if you switch holder
The registration sits in the holder's name, not yours. If the holder is also your distributor, changing or adding a distributor means moving the registration or filing a new one, and where a regulator publishes a transfer process, the current holder has to take part.
Independent holders, firms that hold registrations for makers without selling their products, keep your distributors replaceable. In the Index, 103 of the companies listed here show no sign in the registries that they supply the market themselves, which is a place to start looking; confirm what each one does before you appoint it.
The article Who holds the registration compares holding it yourself, through an independent holder or through your distributor, and lists the clauses to agree before the first order.
Next step
Registration holders in Australia: questions
Who can be a registration holder in Australia?
The sponsor applies to include the device in the Australian Register of Therapeutic Goods (ARTG). It must be an Australian resident, or a body incorporated in Australia that carries on business there.
Can a distributor hold my registration in Australia?
In the Index, 70 of the 521 TGA sponsors listed for Australia are also independent distributors. Whether your distributor should hold it is a separate decision, because the holder controls market access: see Who holds the registration.
Is there a list of TGA sponsors?
Yes. This page lists the top 50 of the 521 TGA sponsors the Index holds for Australia, each linked to its profile, and the CSV carries 520 company rows. The official record is the TGA, Australian Register of Therapeutic Goods (ARTG) search.
How do I check who holds a device registration in Australia?
Use the TGA, Australian Register of Therapeutic Goods (ARTG) search. Search by sponsor name to see the ARTG entries that sponsor holds.
Sources
- Australia TGA ARTG sponsors, Australian UDI Database public download: 521 establishments, last seen 23 October 2026. Australian government public data.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 39 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 28 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 16 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 22 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
Index build 25 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.