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Medical Device 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.

45,899
Active licenses
13,462
Manufacturer names
4,831
License Holder names
59
Manufacturer countries
DJ Fang
DJ Fang
MedTech Regulatory Expert

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Pricing
New licenses by year
201320142015201620172018201920202021202220232024
VerifiedTFDA · data as of 2024-12-24
Active licenses by risk class
Class IClass IIClass III
VerifiedTFDA · data as of 2024-12-24

Licenses by Medical Specialty

Largest medical specialty groups among active licenses

Medical SpecialtyLicensesShare
General, Plastic Surgery and Dermatology6,18213.5%
Dentistry5,53512.1%
Clinical chemistry and clinical toxicology4,81810.5%
General hospital and personal use equipment4,3799.5%
Ophthalmology4,0928.9%
Physical Medical Sciences2,9846.5%
Cardiovascular Medicine Science2,9056.3%
Immunology and microbiology2,5895.6%
Hematology, pathology, and genetics2,2184.8%
Orthopedics2,2034.8%
Gastroenterology and urology2,0534.5%
Anesthesiology1,7493.8%
Radiology Science1,6863.7%
Neuroscience8361.8%
ENT Science7411.6%
Obstetrics and Gynecology5941.3%

Published Manufacturer Countries

Countries associated with manufacturers in this dataset (top 15); these do not establish individual manufacturing-site locations.

#CountryLicensesShare
1Taiwan11,72825.6%
2United States9,76421.3%
3Germany4,56910.0%
4China3,4947.6%
5Japan2,8646.2%
6South Korea1,9834.3%
7United Kingdom1,3452.9%
8France1,1222.4%
9Italy1,1132.4%
10Switzerland8591.9%
11Ireland8441.8%
12Mexico5921.3%
13Israel3720.8%
14Malaysia3620.8%
15Sweden3450.8%

Top 50 Manufacturers in Taiwan

Ranked by active licenses under published names. Name grouping does not establish legal-entity identity or corporate relationships.

RankManufacturerPublished countryLicensesTop categories
#1
ROCHE DIAGNOSTICS GMBHGermany625
Clinical chemistry and clinical toxicology
Immunology and microbiology
Hematology, pathology, and genetics
#2
SIEMENS HEALTHCARE DIAGNOSTICS INC.United States397
Clinical chemistry and clinical toxicology
Immunology and microbiology
Hematology, pathology, and genetics
#3
YUNG SHENG OPTICAL CO., LTD.Taiwan302
Ophthalmology
#4
Taibo Technology Co., Ltd. five-stock factoryTaiwan192
Clinical chemistry and clinical toxicology
Cardiovascular Medicine Science
General hospital and personal use equipment
#5
BECKMAN COULTER INC.United States180
Clinical chemistry and clinical toxicology
Immunology and microbiology
Hematology, pathology, and genetics
#6
I-SEE VISION TECHNOLOGY INC.Taiwan162
Ophthalmology
General, Plastic Surgery and Dermatology
#7
BECKMAN COULTER, INC.United States152
Hematology, pathology, and genetics
Clinical chemistry and clinical toxicology
Immunology and microbiology
#8
ABBOTT IRELAND DIAGNOSTICS DIVISIONIreland144
Clinical chemistry and clinical toxicology
Immunology and microbiology
Hematology, pathology, and genetics
#9
MICROGENICS CORPORATIONUnited States138
Clinical chemistry and clinical toxicology
#10
COOK INCORPORATEDUnited States127
Cardiovascular Medicine Science
Gastroenterology and urology
General, Plastic Surgery and Dermatology
#11
PEGAVISION CORPORATIONTaiwan117
Ophthalmology
#12
BOSTON SCIENTIFIC CORPORATIONUnited States115
Cardiovascular Medicine Science
Gastroenterology and urology
General, Plastic Surgery and Dermatology
#13
Pacific Medical Materials Co., Ltd. Copper FactoryTaiwan110
General hospital and personal use equipment
Anesthesiology
General, Plastic Surgery and Dermatology
#14
BIO-RAD LABORATORIES INC.United States106
Clinical chemistry and clinical toxicology
Immunology and microbiology
Hematology, pathology, and genetics
#15
KARL STORZ SE & Co. KGGermany104
Gastroenterology and urology
ENT Science
General, Plastic Surgery and Dermatology
#16
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITEDUnited Kingdom104
Clinical chemistry and clinical toxicology
Immunology and microbiology
Hematology, pathology, and genetics
#17
SYNTHES GMBHSwitzerland103
Orthopedics
Dentistry
Neuroscience
#18
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AGGermany102
Immunology and microbiology
Hematology, pathology, and genetics
#19
SYNTEC SCIENTIFIC CORPORATIONTaiwan101
Orthopedics
Dentistry
Neuroscience
#20
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBHGermany99
Hematology, pathology, and genetics
Immunology and microbiology
Clinical chemistry and clinical toxicology
#21
APEX BIOTECHNOLOGY CORPORATIONTaiwan97
Clinical chemistry and clinical toxicology
Hematology, pathology, and genetics
Immunology and microbiology
#22
BIOPTIK TECHNOLOGY, INC.Taiwan96
Clinical chemistry and clinical toxicology
Hematology, pathology, and genetics
General, Plastic Surgery and Dermatology
#23
3M COMPANYUnited States95
General hospital and personal use equipment
General, Plastic Surgery and Dermatology
Physical Medical Sciences
#24
Formosa Biomedical Technology Co., Ltd. Yilan FactoryTaiwan90
Clinical chemistry and clinical toxicology
Hematology, pathology, and genetics
Immunology and microbiology
#25
ORTHO-CLINICAL DIAGNOSTICS, INC.United States87
Clinical chemistry and clinical toxicology
Hematology, pathology, and genetics
Immunology and microbiology
#26
IVOCLAR VIVADENT AGLiechtenstein86
Dentistry
#27
COVIDIEN LLC;; CovidienDominican Republic84
General, Plastic Surgery and Dermatology
Gastroenterology and urology
Anesthesiology
#28
Bonte Biotechnology Co., Ltd. Yilan Plant 2Taiwan83
Gastroenterology and urology
Anesthesiology
Cardiovascular Medicine Science
#29
AOMORI OLYMPUS CO., LTD.Japan82
Gastroenterology and urology
General, Plastic Surgery and Dermatology
ENT Science
#30
TONYAR BIOTECH. INC.Taiwan81
Clinical chemistry and clinical toxicology
Hematology, pathology, and genetics
Immunology and microbiology
#31
Abbott MedicalUnited States80
Cardiovascular Medicine Science
Neuroscience
Radiology Science
#32
AESCULAP AGGermany79
Neuroscience
Orthopedics
General, Plastic Surgery and Dermatology
#33
Boston Scientific LimitedIreland79
Cardiovascular Medicine Science
Gastroenterology and urology
General, Plastic Surgery and Dermatology
#34
DIASORIN ITALIA S.P.A.Italy77
Immunology and microbiology
Clinical chemistry and clinical toxicology
Hematology, pathology, and genetics
#35
UNICON OPTICAL CO., LTD.Taiwan76
Ophthalmology
#36
DIAMED GMBHSwitzerland75
Hematology, pathology, and genetics
#37
LARGAN MEDICAL CO., LTD.Taiwan75
Ophthalmology
#38
SEBIAFrance74
Clinical chemistry and clinical toxicology
Immunology and microbiology
Hematology, pathology, and genetics
#39
BECTON DICKINSON AND COMPANYUnited States73
Immunology and microbiology
Clinical chemistry and clinical toxicology
General hospital and personal use equipment
#40
3M Deutschland GmbHGermany71
Dentistry
Radiology Science
#41
BIOMERIEUX SAFrance69
Immunology and microbiology
Clinical chemistry and clinical toxicology
Hematology, pathology, and genetics
#42
Zhaohui Industrial Co., Ltd. Chiayi FactoryTaiwan68
General hospital and personal use equipment
General, Plastic Surgery and Dermatology
Anesthesiology
#43
Alcon Research, LLCUnited States67
Ophthalmology
General, Plastic Surgery and Dermatology
#44
DIESSE DIAGNOSTICA SENESE S.P.A.Italy65
Immunology and microbiology
Hematology, pathology, and genetics
Clinical chemistry and clinical toxicology
#45
FIRSTEP BIORESEARCH INC.Taiwan65
Clinical chemistry and clinical toxicology
Immunology and microbiology
Hematology, pathology, and genetics
#46
SHIRAKAWA OLYMPUS CO., LTD.Japan65
Gastroenterology and urology
ENT Science
Radiology Science
#47
BIO-RADFrance63
Immunology and microbiology
Hematology, pathology, and genetics
#48
BESMED HEALTH BUSINESS CORP.Taiwan62
Anesthesiology
General, Plastic Surgery and Dermatology
General hospital and personal use equipment
#49
SENTINEL CH. SPAItaly62
Clinical chemistry and clinical toxicology
Immunology and microbiology
Hematology, pathology, and genetics
#50
SMART PERFORMER CO., LTD.Taiwan61
Ophthalmology

Top 50 License Holders in Taiwan

Published license holder names ranked by active licenses held. Foreign manufacturers must appoint a Taiwan-based license holder to register with the TFDA.

RankLicense HolderLicensesManufacturers represented
#1
SIEMENS HEALTHCARE LIMITED96594
#2
ROCHE DIAGNOSTICS LTD.88959
#3
ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)728115
#4
BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)71188
#5
MEDTRONIC (TAIWAN) LTD.683173
#6
K&C MEDICAL CO., LTD.464152
#7
JOHNSON & JOHNSON MEDICAL TAIWAN LTD.425122
#8
YUAN LI INSTRUMENT CO., LTD.35236
#9
Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.)34819
#10
BECTON DICKINSON HOLDINGS PTE. LTD. TAIWAN BRANCH (SINGAPORE)34391
#11
Abbott Medical Taiwan Co.30955
#12
Dutch Boston Technology Co., Ltd. Taiwan Branch29457
#13
COOK TAIWAN LIMITED29021
#14
DENTSPLY SIRONA INC., TAIWAN BRANCH (U.S.A.)27665
#15
EMERGO TAIWAN LIMITED268104
#16
STRYKER FAR EAST INC. TAIWAN BRANCH (USA)26868
#17
DKSH TAIWAN LTD.26738
#18
EVERLIGHT BIOTECH(TAIWAN) CO., LTD.26026
#19
QUALTECH CONSULTING CORPORATION247104
#20
SMITH & NEPHEW ( OVERSEAS ) LIMITED, TAIWAN BRANCH (U.K.)24577
#21
TAIDOC TECHNOLOGY CORPORATION23815
#22
MEDICARE PRODUCTS INC.20626
#23
3M Healthcare Taiwan Co., Ltd.20257
#24
PHILIPS TAIWAN LIMITED19763
#25
Taiwan Minnesota Mining Manufacturing Co., Ltd19361
#26
YUNG SHENG OPTICAL CO., LTD.1906
#27
SYSMEX TAIWAN CO., LTD.17832
#28
TERUMO TAIWAN MEDICAL CO., LTD.17550
#29
ST. SHINE OPTICAL CO., LTD.1716
#30
ZIMMER BIOMET TAIWAN CO., LTD.16861
#31
BARD PACIFIC HEALTH CARE CO., LTD.16847
#32
BioLaden Consultant Corp.16628
#33
NOBEL BIOCARE TAIWAN CO., LTD.16674
#34
I-SEE VISION TECHNOLOGY INC.1611
#35
3M TAIWAN LTD.15870
#36
CLINICO INC.15677
#37
TELEFLEX MEDICAL TAIWAN LTD.15260
#38
YONG CHIEH ENTERPRISE CO., LTD.15289
#39
SCN TRADING COMPANY LIMITED14924
#40
ALCON SERVICES AG, TAIWAN BRANCH (SWITZERLAND)14635
#41
TUNYEN ENTERPRISE CORPORATION14613
#42
GE MEDICAL SYSTEMS TAIWAN, LTD.14557
#43
B. BRAUN TAIWAN CO., LTD.13849
#44
FUJIFILM HEALTHCARE TAIWAN CO., LTD.13724
#45
TUNG SHENG INTERNATIONAL INC.13163
#46
KARL STORZ ENDOSCOPY TAIWAN LTD.1267
#47
GRAND MARQUIS CO., LTD.1266
#48
TRUGENE DIAGNOSTICS, INC.12525
#49
APEX BIOTECHNOLOGY CORPORATION11910
#50
PACIFIC HOSPITAL SUPPLY CO., LTD.1166
About the data

What the TFDA medical device registry shows

The Taiwan Food and Drug Administration (TFDA) regulates medical devices in Taiwan. As of 2024-12-24, this official dataset snapshot contains 89,088 license records, of which 45,899 are currently active and 43,189 are cancelled, expired, or withdrawn. The most frequently listed manufacturer name is ROCHE DIAGNOSTICS GMBH with 625 licenses. Taiwan is the most represented manufacturer country, accounting for 11,728 active licenses (25.6%). The dataset lists 4,831 distinct published license holder names.

Every figure is computed from the official dataset snapshot as mirrored in the Pure Global database — “active” excludes cancelled, expired, and withdrawn records. Published company names are grouped by whitespace and case. These name counts do not establish distinct legal entities or corporate relationships. Product and category labels use the derived English value when the current row has one and otherwise preserve the official source-language value. Browse individual records in the searchable Taiwan device database, or see our methodology for how the data is collected.

VerifiedTaiwan Food and Drug Administration · 89,088 records · generated 2026-08-26
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