Registry Insights · TFDA
Taiwan Medical Device Registry Statistics
Aggregated from 89,088 official TFDA license records covering 13,462 manufacturers from 59 countries. Data as of 2024-12-24.
The Taiwan Food and Drug Administration (TFDA) regulates medical devices in Taiwan. As of 2024-12-24, this registry snapshot contains 89,088 license records, of which 45,899 are currently active and 43,189 are cancelled, expired, or withdrawn.
The largest manufacturer by active licenses is ROCHE DIAGNOSTICS GMBH with 625 licenses. Taiwan is the largest country of origin, accounting for 11,728 active licenses (25.6%). The registry lists 4,831 distinct license holders.
Every figure on this page is computed from the official registry snapshot. Browse individual records in the searchable Taiwan device database, or see our methodology for how the data is collected.
45,899
Active licenses
13,462
Manufacturers
4,831
License Holders
59
Origin countries
Licenses by Risk Class
TFDA risk classification of active licenses
| Risk class | Licenses | Share |
|---|---|---|
| Class I | 21,187 | 46.2% |
| Class II | 22,595 | 49.2% |
| Class III | 2,084 | 4.5% |
New Licenses by Year
Licenses issued per year, including records no longer active
| Year | New licenses |
|---|---|
| 2024 | 1,604 |
| 2023 | 1,984 |
| 2022 | 2,624 |
| 2021 | 6,095 |
| 2020 | 3,591 |
| 2019 | 3,763 |
| 2018 | 3,976 |
| 2017 | 4,050 |
| 2016 | 3,824 |
| 2015 | 3,711 |
| 2014 | 3,575 |
| 2013 | 3,981 |
Licenses by Medical Specialty
Largest medical specialty groups among active licenses
| Medical Specialty | Licenses | Share |
|---|---|---|
| General, Plastic Surgery and Dermatology | 6,182 | 13.5% |
| Dentistry | 5,535 | 12.1% |
| Clinical chemistry and clinical toxicology | 4,818 | 10.5% |
| General hospital and personal use equipment | 4,379 | 9.5% |
| Ophthalmology | 4,092 | 8.9% |
| Physical Medical Sciences | 2,984 | 6.5% |
| Cardiovascular Medicine Science | 2,905 | 6.3% |
| Immunology and microbiology | 2,589 | 5.6% |
| Hematology, pathology, and genetics | 2,218 | 4.8% |
| Orthopedics | 2,203 | 4.8% |
| Gastroenterology and urology | 2,053 | 4.5% |
| Anesthesiology | 1,749 | 3.8% |
| Radiology Science | 1,686 | 3.7% |
| Neuroscience | 836 | 1.8% |
| ENT Science | 741 | 1.6% |
| Obstetrics and Gynecology | 594 | 1.3% |
Manufacturer Countries of Origin
Where devices registered in Taiwan are manufactured (top 15)
| # | Country | Licenses | Share |
|---|---|---|---|
| 1 | Taiwan | 11,728 | 25.6% |
| 2 | United States | 9,764 | 21.3% |
| 3 | Germany | 4,569 | 10.0% |
| 4 | China | 3,494 | 7.6% |
| 5 | Japan | 2,864 | 6.2% |
| 6 | South Korea | 1,983 | 4.3% |
| 7 | United Kingdom | 1,345 | 2.9% |
| 8 | France | 1,122 | 2.4% |
| 9 | Italy | 1,113 | 2.4% |
| 10 | Switzerland | 859 | 1.9% |
| 11 | Ireland | 844 | 1.8% |
| 12 | Mexico | 592 | 1.3% |
| 13 | Israel | 372 | 0.8% |
| 14 | Malaysia | 362 | 0.8% |
| 15 | Sweden | 345 | 0.8% |
Top 50 Manufacturers in Taiwan
Ranked by active licenses. Company names are normalized; affiliated legal entities are listed separately, as registered.
| Rank | Manufacturer | Origin | Licenses | Top categories |
|---|---|---|---|---|
#1 | ROCHE DIAGNOSTICS GMBH | Germany | 625 | Clinical chemistry and clinical toxicology Immunology and microbiology Hematology, pathology, and genetics |
#2 | SIEMENS HEALTHCARE DIAGNOSTICS INC. | United States | 397 | Clinical chemistry and clinical toxicology Immunology and microbiology Hematology, pathology, and genetics |
#3 | YUNG SHENG OPTICAL CO., LTD. | Taiwan | 302 | Ophthalmology |
#4 | Taibo Technology Co., Ltd. five-stock factory | Taiwan | 192 | Clinical chemistry and clinical toxicology Cardiovascular Medicine Science General hospital and personal use equipment |
#5 | BECKMAN COULTER INC. | United States | 180 | Clinical chemistry and clinical toxicology Immunology and microbiology Hematology, pathology, and genetics |
#6 | I-SEE VISION TECHNOLOGY INC. | Taiwan | 162 | Ophthalmology General, Plastic Surgery and Dermatology |
#7 | BECKMAN COULTER, INC. | United States | 152 | Hematology, pathology, and genetics Clinical chemistry and clinical toxicology Immunology and microbiology |
#8 | ABBOTT IRELAND DIAGNOSTICS DIVISION | Ireland | 144 | Clinical chemistry and clinical toxicology Immunology and microbiology Hematology, pathology, and genetics |
#9 | MICROGENICS CORPORATION | United States | 138 | Clinical chemistry and clinical toxicology |
#10 | COOK INCORPORATED | United States | 127 | Cardiovascular Medicine Science Gastroenterology and urology General, Plastic Surgery and Dermatology |
#11 | PEGAVISION CORPORATION | Taiwan | 117 | Ophthalmology |
#12 | BOSTON SCIENTIFIC CORPORATION | United States | 115 | Cardiovascular Medicine Science Gastroenterology and urology General, Plastic Surgery and Dermatology |
#13 | Pacific Medical Materials Co., Ltd. Copper Factory | Taiwan | 110 | General hospital and personal use equipment Anesthesiology General, Plastic Surgery and Dermatology |
#14 | BIO-RAD LABORATORIES INC. | United States | 106 | Clinical chemistry and clinical toxicology Immunology and microbiology Hematology, pathology, and genetics |
#15 | KARL STORZ SE & Co. KG | Germany | 104 | Gastroenterology and urology ENT Science General, Plastic Surgery and Dermatology |
#16 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED | United Kingdom | 104 | Clinical chemistry and clinical toxicology Immunology and microbiology Hematology, pathology, and genetics |
#17 | SYNTHES GMBH | Switzerland | 103 | Orthopedics Dentistry Neuroscience |
#18 | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | Germany | 102 | Immunology and microbiology Hematology, pathology, and genetics |
#19 | SYNTEC SCIENTIFIC CORPORATION | Taiwan | 101 | Orthopedics Dentistry Neuroscience |
#20 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH | Germany | 99 | Hematology, pathology, and genetics Immunology and microbiology Clinical chemistry and clinical toxicology |
#21 | APEX BIOTECHNOLOGY CORPORATION | Taiwan | 97 | Clinical chemistry and clinical toxicology Hematology, pathology, and genetics Immunology and microbiology |
#22 | BIOPTIK TECHNOLOGY, INC. | Taiwan | 96 | Clinical chemistry and clinical toxicology Hematology, pathology, and genetics General, Plastic Surgery and Dermatology |
#23 | 3M COMPANY | United States | 95 | General hospital and personal use equipment General, Plastic Surgery and Dermatology Physical Medical Sciences |
#24 | Formosa Biomedical Technology Co., Ltd. Yilan Factory | Taiwan | 90 | Clinical chemistry and clinical toxicology Hematology, pathology, and genetics Immunology and microbiology |
#25 | ORTHO-CLINICAL DIAGNOSTICS, INC. | United States | 87 | Clinical chemistry and clinical toxicology Hematology, pathology, and genetics Immunology and microbiology |
#26 | IVOCLAR VIVADENT AG | Liechtenstein | 86 | Dentistry |
#27 | COVIDIEN LLC;; Covidien | Dominican Republic | 84 | General, Plastic Surgery and Dermatology Gastroenterology and urology Anesthesiology |
#28 | Bonte Biotechnology Co., Ltd. Yilan Plant 2 | Taiwan | 83 | Gastroenterology and urology Anesthesiology Cardiovascular Medicine Science |
#29 | AOMORI OLYMPUS CO., LTD. | Japan | 82 | Gastroenterology and urology General, Plastic Surgery and Dermatology ENT Science |
#30 | TONYAR BIOTECH. INC. | Taiwan | 81 | Clinical chemistry and clinical toxicology Hematology, pathology, and genetics Immunology and microbiology |
#31 | Abbott Medical | United States | 80 | Cardiovascular Medicine Science Neuroscience Radiology Science |
#32 | AESCULAP AG | Germany | 79 | Neuroscience Orthopedics General, Plastic Surgery and Dermatology |
#33 | Boston Scientific Limited | Ireland | 79 | Cardiovascular Medicine Science Gastroenterology and urology General, Plastic Surgery and Dermatology |
#34 | DIASORIN ITALIA S.P.A. | Italy | 77 | Immunology and microbiology Clinical chemistry and clinical toxicology Hematology, pathology, and genetics |
#35 | UNICON OPTICAL CO., LTD. | Taiwan | 76 | Ophthalmology |
#36 | DIAMED GMBH | Switzerland | 75 | Hematology, pathology, and genetics |
#37 | LARGAN MEDICAL CO., LTD. | Taiwan | 75 | Ophthalmology |
#38 | SEBIA | France | 74 | Clinical chemistry and clinical toxicology Immunology and microbiology Hematology, pathology, and genetics |
#39 | BECTON DICKINSON AND COMPANY | United States | 73 | Immunology and microbiology Clinical chemistry and clinical toxicology General hospital and personal use equipment |
#40 | 3M Deutschland GmbH | Germany | 71 | Dentistry Radiology Science |
#41 | BIOMERIEUX SA | France | 69 | Immunology and microbiology Clinical chemistry and clinical toxicology Hematology, pathology, and genetics |
#42 | Zhaohui Industrial Co., Ltd. Chiayi Factory | Taiwan | 68 | General hospital and personal use equipment General, Plastic Surgery and Dermatology Anesthesiology |
#43 | Alcon Research, LLC | United States | 67 | Ophthalmology General, Plastic Surgery and Dermatology |
#44 | DIESSE DIAGNOSTICA SENESE S.P.A. | Italy | 65 | Immunology and microbiology Hematology, pathology, and genetics Clinical chemistry and clinical toxicology |
#45 | FIRSTEP BIORESEARCH INC. | Taiwan | 65 | Clinical chemistry and clinical toxicology Immunology and microbiology Hematology, pathology, and genetics |
#46 | SHIRAKAWA OLYMPUS CO., LTD. | Japan | 65 | Gastroenterology and urology ENT Science Radiology Science |
#47 | BIO-RAD | France | 63 | Immunology and microbiology Hematology, pathology, and genetics |
#48 | BESMED HEALTH BUSINESS CORP. | Taiwan | 62 | Anesthesiology General, Plastic Surgery and Dermatology General hospital and personal use equipment |
#49 | SENTINEL CH. SPA | Italy | 62 | Clinical chemistry and clinical toxicology Immunology and microbiology Hematology, pathology, and genetics |
#50 | SMART PERFORMER CO., LTD. | Taiwan | 61 | Ophthalmology |
Top 50 License Holders in Taiwan
Local license holders ranked by active licenses held. Foreign manufacturers must appoint a Taiwan-based license holder to register with the TFDA.
About this data: statistics are computed from the official Taiwan Food and Drug Administration registry as mirrored in the Pure Global database (89,088 records, newest registration dated 2024-12-24; page generated 2026-08-05). “Active” excludes cancelled, expired, and withdrawn records. Company names are normalized for whitespace and case, but distinct legal entities of the same group are counted separately. See methodology.