Registry Insights · HSA
Singapore Medical Device Registry Statistics
Aggregated from 20,221 official HSA registration records covering 3,997 product owners. Data as of 2025-05-15.
The Health Sciences Authority (HSA) regulates medical devices in Singapore. As of 2025-05-15, this registry snapshot contains 20,221 registration records.
The largest product owner by registrations is Roche Diagnostics GmbH with 368 registrations. The registry lists 854 distinct registrants.
Every figure on this page is computed from the official registry snapshot. Browse individual records in the searchable Singapore device database, or see our methodology for how the data is collected.
20,221
Registrations
3,997
Product Owners
854
Registrants
Registrations by Risk Class
HSA risk classification of registrations
| Risk class | Registrations | Share |
|---|---|---|
| Class B | 9,084 | 44.9% |
| Class C | 4,778 | 23.6% |
| Class B (IVD) | 2,481 | 12.3% |
| Class D | 1,995 | 9.9% |
| Class C (IVD) | 1,314 | 6.5% |
| Class D (IVD) | 377 | 1.9% |
New Registrations by Year
Registrations issued per year
| Year | New registrations |
|---|---|
| 2025 | 525 |
| 2024 | 1,287 |
| 2023 | 1,064 |
| 2022 | 964 |
| 2021 | 1,068 |
| 2020 | 1,143 |
| 2019 | 1,089 |
| 2018 | 1,188 |
| 2017 | 970 |
| 2016 | 881 |
| 2015 | 808 |
| 2014 | 1,383 |
Registrations by Medical Specialty
Largest medical specialty groups among registrations
| Medical Specialty | Registrations | Share |
|---|---|---|
| General Hospital | 3,907 | 19.3% |
| Cardiovascular | 1,683 | 8.3% |
| General & Plastic Surgery | 1,637 | 8.1% |
| Orthopaedics | 1,579 | 7.8% |
| Dental | 1,545 | 7.6% |
| Immunology | 1,380 | 6.8% |
| Clinical chemistry | 1,368 | 6.8% |
| Ophthalmology | 1,338 | 6.6% |
| Radiology / Imaging | 1,276 | 6.3% |
| Gastroenterology & Urology | 998 | 4.9% |
| Ear, Nose & Throat | 718 | 3.6% |
| Microbiology | 588 | 2.9% |
| Anaesthesiology | 519 | 2.6% |
| Hematology | 519 | 2.6% |
| Obstetrics & Gynaecology | 394 | 1.9% |
| Neurology | 387 | 1.9% |
| Pathology | 130 | 0.6% |
| Physical Medicine | 127 | 0.6% |
| Clinical toxicology | 118 | 0.6% |
Top 50 Product Owners in Singapore
Ranked by registrations. Company names are normalized; affiliated legal entities are listed separately, as registered.
| Rank | Product Owner | Registrations | Top categories |
|---|---|---|---|
#1 | Roche Diagnostics GmbH | 368 | Clinical chemistry Immunology Pathology |
#2 | Siemens Healthcare Diagnostics Inc | 328 | Clinical chemistry Immunology Clinical toxicology |
#3 | Boston Scientific Corporation | 260 | Gastroenterology & Urology Cardiovascular General & Plastic Surgery |
#4 | Beckman Coulter Inc | 247 | Clinical chemistry Immunology Microbiology |
#5 | Covidien llc | 246 | General Hospital General & Plastic Surgery Anaesthesiology |
#6 | Synthes GmbH | 227 | Orthopaedics General & Plastic Surgery General Hospital |
#7 | KARL STORZ SE & Co. KG | 179 | General & Plastic Surgery Gastroenterology & Urology Ear, Nose & Throat |
#8 | Abbott Ireland Diagnostics Division | 166 | Immunology Clinical chemistry Microbiology |
#9 | Medtronic Inc. | 145 | Cardiovascular Neurology General Hospital |
#10 | Abbott GmbH | 142 | Immunology Clinical chemistry Microbiology |
#11 | EUROIMMUN Medizinische Labordiagnostika AG | 132 | Immunology Microbiology Clinical chemistry |
#12 | Alcon Laboratories, Inc. | 115 | Ophthalmology |
#13 | Abbott Medical | 105 | Cardiovascular General & Plastic Surgery General Hospital |
#14 | Cook Incorporated | 105 | Gastroenterology & Urology General & Plastic Surgery Cardiovascular |
#15 | Siemens Healthcare Diagnostics Products Limited | 100 | Immunology Clinical chemistry Microbiology |
#16 | Ortho-Clinical Diagnostics | 96 | Immunology Hematology Clinical chemistry |
#17 | AESCULAP AG | 92 | General & Plastic Surgery Neurology Orthopaedics |
#18 | Medtronic Sofamor Danek USA, Inc. | 92 | Orthopaedics General Hospital General & Plastic Surgery |
#19 | Becton, Dickinson and Company | 91 | Microbiology General Hospital Anaesthesiology |
#20 | Arthrex, Inc. | 84 | Orthopaedics General & Plastic Surgery General Hospital |
#21 | Siemens Healthcare GmbH | 82 | Radiology / Imaging General Hospital |
#22 | Ortho-Clinical Diagnostic Inc | 80 | Clinical chemistry Immunology Clinical toxicology |
#23 | Dragerwerk AG & Co. KGaA | 79 | Anaesthesiology General Hospital General & Plastic Surgery |
#24 | Medtronic, Inc | 79 | Cardiovascular General Hospital General & Plastic Surgery |
#25 | Olympus Medical Systems Corp. | 75 | Gastroenterology & Urology General & Plastic Surgery General Hospital |
#26 | Siemens Healthcare Diagnostics Products GmbH | 75 | Hematology Immunology Clinical chemistry |
#27 | Zimmer Inc | 71 | Orthopaedics |
#28 | ORGENTEC Diagnostika GmbH | 70 | Immunology Pathology |
#29 | Medos International SARL | 67 | Orthopaedics General & Plastic Surgery Neurology |
#30 | Smiths Medical ASD, Inc. | 63 | General Hospital Anaesthesiology Ear, Nose & Throat |
#31 | Diagnostica Stago S.A.S | 62 | Immunology Hematology |
#32 | Philips Medical Systems Nederland B.V. | 60 | Radiology / Imaging General Hospital Cardiovascular |
#33 | Nakanishi Inc. | 59 | Dental Orthopaedics |
#34 | Kerr Corporation | 57 | Dental |
#35 | Fujifilm Corporation | 55 | Radiology / Imaging Gastroenterology & Urology General Hospital |
#36 | Johnson & Johnson Surgical Vision, Inc. | 54 | Ophthalmology |
#37 | Respironics, Inc. | 54 | General Hospital Anaesthesiology Ear, Nose & Throat |
#38 | Instrumentation Laboratory Company | 53 | Hematology Immunology |
#39 | Nobel Biocare AB | 53 | Dental General Hospital General & Plastic Surgery |
#40 | Fresenius Medical Care AG | 52 | General Hospital Gastroenterology & Urology |
#41 | Bio-Rad Laboratories | 51 | Immunology Clinical chemistry Hematology |
#42 | Cook Medical Incorporated | 51 | Cardiovascular General & Plastic Surgery Gastroenterology & Urology |
#43 | Phadia AB | 51 | Immunology |
#44 | TERUMO CORPORATION | 51 | General Hospital Cardiovascular General & Plastic Surgery |
#45 | Bard Peripheral Vascular, Inc | 50 | Cardiovascular General & Plastic Surgery Obstetrics & Gynaecology |
#46 | Molnlycke Health Care AB | 50 | General Hospital General & Plastic Surgery Cardiovascular |
#47 | Symmetry Surgical Inc. | 50 | General & Plastic Surgery Neurology Ear, Nose & Throat |
#48 | B.Braun Melsungen AG | 49 | General Hospital Cardiovascular Anaesthesiology |
#49 | Carl Zeiss Meditec AG | 49 | Ophthalmology Neurology General & Plastic Surgery |
#50 | Institut Straumann AG | 49 | Dental |
Top 50 Registrants in Singapore
Local registrants ranked by registrations held. Only a Singapore-based registrant can hold HSA device registrations for a product owner.
About this data: statistics are computed from the official Health Sciences Authority registry as mirrored in the Pure Global database (20,221 records, newest registration dated 2025-05-15; 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.