Taiwan device registration in numbers: 4,475 companies, 22,350 valid device licences

This note covers a single market — Taiwan. The official source is TFDA. How many companies and records the database holds here, how classes break down, what share is Chinese, and how to read the figures. Data as of 2026-09-07.

What the database holds here

In Taiwan, 4,475 companies have records, 22,350 valid device licences in total, averaging 5.0 each. By company location: USA 1,148, China 785, Germany 421, Korea, Republic 320, 未标注 255, Japan 212.

799 of those companies are from mainland China, Hong Kong, Taiwan or Macau (18%). 2,615 of the companies here also hold records in five or more markets, which is the multi-market group.

Class distribution

II 12,680, I 8,402, III 1,258, 未分级 10.

Class fields are defined differently in each jurisdiction and do not map across markets: EU Class IIa/IIb is not the same thing as China Class II, and the evidence route for US Class II differs from EU Class IIa. Which column each class figure is taken from is listed at the methodology page.

Companies with the most records

Company	Country	valid device licences	Markets
Roche Diagnostics S.L.	Spain	583	8
Siemens Healthcare Diagnostics, Inc.	USA	484	11
BECKMAN COULTER, INC.	USA	268	10
BIO - RAD LABORATORIES INC.	USA	164	11
Microgenics Corporation	USA	155	10
Boston Scientific Corporation -	USA	138	11
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED	Germany	117	10
Biomerieux Sa, Inc.	France	115	9
BECTON, DICKINSON AND COMPANY LIMITED	USA	113	11
Smith & Nephew Medical (Shanghai) Limited	China	109	12
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG	Germany	105	10
Siemens Healthcare Diagnostic Products GmbH	Germany	100	11

How much was excluded during verification

Matching in this market runs against a bulk export compared locally, with verification performed at import time.

How to verify this yourself

Every market figure on this site is the result of **re-checking each manufacturer name record by record**, not a raw hit count from a registry search interface. Name search in these registries is generally a substring match: searching EUDAMED for "Edan" returns 1,933 records, of which 434 belong to HANEDAN in Turkey and 300 to TeDan Surgical in the United States — taking the raw count would overstate by more than 60 percent. We therefore require the distinctive token to appear as a whole word and demand a genuinely distinguishing shared token; generic words such as "medical" or "systems" never qualify on their own, and the similar names that were excluded are listed on each company page. Each market counts a different unit (the EU counts UDI-DI device records, the US counts listed device types, Canada and Brazil count valid registrations, Korea counts quality-system certifications), so figures cannot be summed or compared across markets. The full basis, official portals and query paths are at the methodology page.

This database; source data from TFDA