South Korea device registration in numbers: 2,248 companies, 3,921 GMP quality-system certificates

This note covers a single market — South Korea. The official source is MFDS. 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 South Korea, 2,248 companies have records, 3,921 GMP quality-system certificates in total, averaging 1.7 each. By company location: USA 554, China 435, Germany 203, Japan 125, 未标注 88, France 80.

475 of those companies are from mainland China, Hong Kong, Taiwan or Macau (21%). 1,474 of the companies here also hold records in five or more markets, which is the multi-market group.

Class distribution

수입업 3,215, 체외진단수입업 487, 未标注 136, 제조업 78, 체외진단제조업 5. Note: this is a pre-market quality-system certification, not per-device registration.

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	GMP quality-system certificates	Markets
Abbott Medical	USA	29	11
Boston Scientific Corporation -	USA	19	11
Smith & Nephew Medical (Shanghai) Limited	China	16	12
BECKMAN COULTER, INC.	USA	14	10
Bain Medical Equipment (Guangzhou) Co., Ltd.	China	13	13
GE HealthCare	China	13	12
LAKE REGION MEDICAL LIMITED	Ireland	13	9
Siemens Healthineers Ltd.	China	12	10
Abbott Vascular, Inc.	USA	12	10
FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, L.L.C.	USA	12	8
Guangdong Transtek Medical Co.,Ltd	China	11	13
Well Lead Medical Co., Ltd.	China	11	13

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 MFDS