Registry Insights · TGA
Australia Medical Device Registry Statistics
Aggregated from 131,192 official TGA ARTG entry records covering 12,017 manufacturers from 66 countries. Data as of 2025-03-27.
The Therapeutic Goods Administration (TGA) regulates medical devices in Australia. As of 2025-03-27, this registry snapshot contains 131,192 ARTG entry records.
The largest manufacturer by ARTG entries is Zimmer Inc with 2,594 ARTG entries. United States is the largest country of origin, accounting for 43,456 ARTG entries (33.1%). The registry lists 4,164 distinct sponsors.
Every figure on this page is computed from the official registry snapshot. Browse individual records in the searchable Australia device database, or see our methodology for how the data is collected.
131,192
ARTG entries
12,017
Manufacturers
4,164
Sponsors
66
Origin countries
ARTG Entries by Risk Class
TGA risk classification of ARTG entries
| Risk class | ARTG entries | Share |
|---|---|---|
| Class I | 63,737 | 48.6% |
| Class IIa | 31,626 | 24.1% |
| Class IIb | 16,521 | 12.6% |
| Class III | 12,252 | 9.3% |
| Class Is | 5,515 | 4.2% |
| Class Im | 1,176 | 0.9% |
| AIMD | 365 | 0.3% |
New ARTG Entries by Year
ARTG entries issued per year
| Year | New ARTG entries |
|---|---|
| 2025 | 1,219 |
| 2024 | 7,802 |
| 2023 | 8,271 |
| 2022 | 8,358 |
| 2021 | 9,078 |
| 2020 | 9,487 |
| 2019 | 6,982 |
| 2018 | 10,430 |
| 2017 | 7,555 |
| 2016 | 6,939 |
| 2015 | 8,590 |
| 2014 | 7,284 |
ARTG Entries by Device Type (GMDN)
Largest device type (GMDN) groups among ARTG entries
| Device Type (GMDN) | ARTG entries | Share |
|---|---|---|
| CT943 - Instrument/analyser IVDs | 775 | 0.6% |
| 56286 - Nitrile examination/treatment glove, non-powdered | 643 | 0.5% |
| 46585 - Prosthesis, knee, internal, insert component | 586 | 0.4% |
| 44054 - Surgical procedure kit, orthopaedic, reusable | 465 | 0.4% |
| 12143 - Tray, instrument | 462 | 0.4% |
| 35492 - Gown, isolation, single use | 451 | 0.3% |
| 35177 - Mask, surgical, single use | 435 | 0.3% |
| 32831 - Uncoated knee femur prosthesis | 409 | 0.3% |
| CT945 - General laboratoryware IVDs | 407 | 0.3% |
| CT936 - Specimen receptacle IVDs | 395 | 0.3% |
| 33968 - Screwdriver, surgical | 392 | 0.3% |
| 43167 - Acetabular shell | 380 | 0.3% |
| 12726 - Holder, needle | 353 | 0.3% |
| 35079 - Forceps, <specify> | 342 | 0.3% |
| 32832 - Uncoated knee tibia prosthesis, metallic | 334 | 0.3% |
| 13730 - Sterilization container | 334 | 0.3% |
| 35642 - Fixation system, internal,fracture, non-biodegradable | 332 | 0.3% |
| 47487 - Medical device electrical cable, general purpose | 329 | 0.3% |
| 13180 - Orthopaedic prosthesis implantation instrument, reusable | 322 | 0.2% |
| 35094 - Catheter guide wire | 315 | 0.2% |
Manufacturer Countries of Origin
Where devices registered in Australia are manufactured (top 15)
| # | Country | ARTG entries | Share |
|---|---|---|---|
| 1 | United States | 43,456 | 33.1% |
| 2 | Germany | 17,320 | 13.2% |
| 3 | China | 14,814 | 11.3% |
| 4 | Australia | 9,844 | 7.5% |
| 5 | United Kingdom | 6,529 | 5.0% |
| 6 | Switzerland | 5,085 | 3.9% |
| 7 | Italy | 4,017 | 3.1% |
| 8 | France | 3,856 | 2.9% |
| 9 | South Korea | 2,513 | 1.9% |
| 10 | Japan | 2,147 | 1.6% |
| 11 | Sweden | 1,853 | 1.4% |
| 12 | Taiwan | 1,766 | 1.3% |
| 13 | Pakistan | 1,661 | 1.3% |
| 14 | Ireland | 1,577 | 1.2% |
| 15 | Denmark | 1,530 | 1.2% |
Top 50 Manufacturers in Australia
Ranked by ARTG entries. Company names are normalized; affiliated legal entities are listed separately, as registered.
| Rank | Manufacturer | Origin | ARTG entries | Top categories |
|---|---|---|---|---|
#1 | Zimmer Inc | United States | 2,594 | 46585 - Prosthesis, knee, internal, insert component 35642 - Fixation system, internal,fracture, non-biodegradable 44742 - Prosthetic joint implantation kit |
#2 | Medtronic Inc | United States | 1,569 | 47270 - Biventricular pacemaker/defibrillator 61393 - Multi-purpose electrical stimulation system programmer 35852 - Defibrillator, implantable, automatic |
#3 | Covidien llc | United States | 849 | 35615 - Surgical staple, non-bioabsorbable 41920 - Patient monitor, anaesthesia depth 32369 - Applier, surgical, staple |
#4 | Biomet Orthopedics | United States | 704 | 46585 - Prosthesis, knee, internal, insert component 34198 - Coated knee tibia prosthesis 32832 - Uncoated knee tibia prosthesis, metallic |
#5 | Boston Scientific Corporation | United States | 679 | 35094 - Catheter guide wire 17846 - Catheter, intravascular, guiding 46355 - Electrophysiology cardiac catheter, single-use |
#6 | Abbott Medical | United States | 633 | 35094 - Catheter guide wire 45418 - Cardiac occluder 35853 - Lead, defibrillator, implantable |
#7 | Synthes GmbH | Switzerland | 604 | 35647 - Fixation device, external, system 46479 - Surgical implant template, reusable 32847 - Fixation device, internal, nut |
#8 | Arthrex Inc | United States | 595 | 45039 - Fixation screw, bone, biodegradable 45061 - Fixation anchor, soft-tissue, biodegradable 32854 - Orthopaedic bone pin, non-bioabsorbable |
#9 | Howmedica Osteonics Corporation | United States | 586 | 33692 - Rotating hinged total knee prosthesis 43167 - Acetabular shell 32831 - Uncoated knee femur prosthesis |
#10 | Cochlear Ltd | Australia | 568 | 47373 - Cochlear implant system electrode array assembly 35643 - Stimulator, electrical, auditory, cochlea 58184 - Cochlear implant system coil |
#11 | Aesculap AG | Germany | 500 | 32831 - Uncoated knee femur prosthesis 32832 - Uncoated knee tibia prosthesis, metallic 13730 - Sterilization container |
#12 | Smith & Nephew Inc | United States | 491 | 32831 - Uncoated knee femur prosthesis 46585 - Prosthesis, knee, internal, insert component 43167 - Acetabular shell |
#13 | Depuy Orthopaedics Inc | United States | 437 | 46585 - Prosthesis, knee, internal, insert component 43167 - Acetabular shell 33692 - Rotating hinged total knee prosthesis |
#14 | ConMed Corporation | United States | 434 | 37861 - Evacuator, smoke, surgical 45062 - Soft-tissue anchor, non-bioabsorbable 31723 - Suction system filter, smoke plume particulate |
#15 | Medos International SARL | Switzerland | 413 | 45061 - Fixation anchor, soft-tissue, biodegradable 10691 - Intravascular microflow catheter 33968 - Screwdriver, surgical |
#16 | Karl Storz SE & Co KG | Germany | 390 | 35507 - Cable, fibreoptic 35158 - Light source, endoscope, line powered 17633 - Urethrotome |
#17 | DePuy Ireland UC | Ireland | 386 | 46585 - Prosthesis, knee, internal, insert component 43167 - Acetabular shell 33692 - Rotating hinged total knee prosthesis |
#18 | Livingstone International Pty Ltd | Australia | 372 | 64821 - Public face mask, single-use 11028 - Cotton ball 12505 - Cup, medicine |
#19 | Dragerwerk AG & Co KGaA | Germany | 365 | 37706 - Breathing circuit, ventilator, single use 61346 - Tube/mask breathing circuit connector, non-sterile, single-use 35254 - Probe, thermometer, single use |
#20 | Medacta International SA | Switzerland | 353 | 58228 - Bicompartmental knee prosthesis 35661 - Acetabulum prosthesis 55834 - Press-fit hip femur prosthesis, one-piece |
#21 | Smiths Medical ASD Inc | United States | 353 | 35072 - Filter, intravenous line 33923 - Port/catheter, internal, subcutaneous 46308 - Anaesthesia kit, epidural/spinal |
#22 | InstruMED | Australia | 338 | 37096 - Cable, <specify> 32767 - Hook, ophthalmic 10824 - Chisel, <specify> |
#23 | Implantcast GmbH | Germany | 337 | 32831 - Uncoated knee femur prosthesis 46585 - Prosthesis, knee, internal, insert component 32832 - Uncoated knee tibia prosthesis, metallic |
#24 | Dr Frigz International Pvt Ltd | Pakistan | 336 | 37096 - Cable, <specify> 10520 - Bur, cranial 10824 - Chisel, <specify> |
#25 | St Jude Medical | United States | 314 | 44867 - Catheter, cardiac, electrophysiological mapping 44040 - Neural-tissue electrical stimulation lead 37307 - Brain electrical stimulation system, antitremor |
#26 | Limacorporate Spa | Italy | 309 | 34191 - Coated femoral stem prosthesis, modular 43167 - Acetabular shell 36259 - Prosthesis, internal, joint, shoulder, glenoid component |
#27 | Multigate Co Ltd | China | 308 | 16779 - Suction system tubing 33961 - Surgical procedure kit, general-purpose, single-use, non-medicated 45130 - Bag, tissue extraction |
#28 | RZ Medizintechnik GmbH | Germany | 300 | 12726 - Holder, needle 45716 - Suture knot pusher, reusable 45597 - Trocar sleeve seal/port reducer |
#29 | Coloplast AS | Denmark | 298 | 46207 - Peristomal/periwound dressing 35645 - Prosthesis, internal, stent, ureteral 31075 - Bag, colostomy, open-ended, one-piece |
#30 | Biomet Trauma | United States | 290 | 35685 - Fixation device, internal, wire 13180 - Orthopaedic prosthesis implantation instrument, reusable 33968 - Screwdriver, surgical |
#31 | Carefusion | United States | 290 | 12726 - Holder, needle 62468 - Soft-tissue surgical forceps, scissors-like, reusable 47797 - Pleural/peritoneal cavity drain-insertion set |
#32 | Medtronic Sofamor Danek USA Inc | United States | 282 | 57972 - Radio-frequency lesion system 61324 - Bone-screw internal spinal fixation system, sterile 35124 - Rack, instrumentation/devices |
#33 | Smith & Nephew Inc Endoscopy Division | United States | 281 | 45061 - Fixation anchor, soft-tissue, biodegradable 36174 - Ligament anchor 44093 - Surgical procedure kit, arthroscopic, single-use, non-medicated |
#34 | Stryker Spine | United States | 278 | 45253 - Orthopaedic cement preparation/delivery kit 44759 - Fixation system implantation kit, internal 61325 - Bone-screw internal spinal fixation system, non-sterile |
#35 | Teleflex Medical | United States | 278 | 13907 - Suture, polyethylene 42424 - Airway, oropharyngeal, single use 31328 - Endobronchial tube |
#36 | Stryker Leibinger GmbH & Co KG | Germany | 275 | 33968 - Screwdriver, surgical 46268 - Cranioplasty plate, non-alterable 38723 - Robot, surgical, navigation unit |
#37 | Cook Incorporated | United States | 274 | 35094 - Catheter guide wire 10688 - Catheter, angiography 38821 - Endotherapy dilator, single use |
#38 | Stryker Instruments | United States | 273 | 47998 - Surgical fluid/smoke waste management system 14074 - Tourniquet, pneumatic 43962 - Drilling power tool attachment, basic |
#39 | Symmetry Surgical Inc | United States | 272 | 11254 - Dilator, <specify> 35541 - Rongeur, surgical, intervertebral disc 37101 - Cannula, <specify> |
#40 | Olympus Medical Systems Corporation | Japan | 266 | 36273 - Ultrasonic surgical system generator 34540 - Light source/processing unit, endoscope 38711 - Endotherapy forceps, biopsy, flexible, single-use |
#41 | Fresenius Kabi AG | Germany | 264 | 17605 - Blood cell wash set, autotransfusion 64461 - Enteral feeding noninvasive-component set 44904 - Blood/tissue storage/culture container |
#42 | Gebruder Martin GmbH & Co KG | Germany | 263 | 33968 - Screwdriver, surgical 47848 - Open-surgery electrosurgical forceps, reusable 46642 - Cranofacial fixation plate, non-biodegradable |
#43 | AS Medizintechnik GmbH | Germany | 262 | 10172 - Applicator, <specify> 10876 - Clamp, surgical, umbilical 10520 - Bur, cranial |
#44 | Depuy Mitek (a Johnson & Johnson Company) | United States | 260 | 45061 - Fixation anchor, soft-tissue, biodegradable 45062 - Soft-tissue anchor, non-bioabsorbable 36174 - Ligament anchor |
#45 | Fisher & Paykel Healthcare Ltd | New Zealand | 260 | 12050 - Humidifier, heated 40582 - Ventilator, software 57815 - CPAP/BiPAP nasal mask, reusable |
#46 | St Jude Medical Cardiac Rhythm Management Division | United States | 257 | 35852 - Defibrillator, implantable, automatic 36241 - Lead, defibrillator/pacemaker, implantable 17613 - Catheter, cardiac, ventricular |
#47 | Depuy International | United Kingdom | 248 | 33175 - Metallic femoral head prosthesis 32854 - Orthopaedic bone pin, non-bioabsorbable 13180 - Orthopaedic prosthesis implantation instrument, reusable |
#48 | Stryker GmbH | Switzerland | 245 | 61689 - Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile 44054 - Surgical procedure kit, orthopaedic, reusable 61688 - Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile |
#49 | Edwards Lifesciences LLC | United States | 242 | 34925 - Catheter, cardiac, balloon, thermal dilution 60242 - Aortic heart valve bioprosthesis 66209 - Valve-non-specific transcatheter heart valve bioprosthesis |
#50 | Richard Wolf GmbH | Germany | 239 | 33607 - Endoscope accessory, <specify> 14154 - Trocar, <specify> 37182 - Rectoscope, TEM |
Top 50 Sponsors in Australia
Local sponsors ranked by ARTG entries held. Only an Australian sponsor can hold ARTG entries on behalf of a manufacturer.
About this data: statistics are computed from the official Therapeutic Goods Administration registry as mirrored in the Pure Global database (131,192 records, newest registration dated 2025-03-27; page generated 2026-08-05). Company names are normalized for whitespace and case, but distinct legal entities of the same group are counted separately. See methodology.