One question: how many Chinese manufacturers in this database hold registrations in South Korea, how many each, where they are based, and what limits apply to these figures. Data as of 2026-09-07.
Scale and share
In South Korea the database finds 2,248 companies with records. 475 are from mainland China, Hong Kong, Taiwan or Macau (21%), holding 922 GMP quality-system certificates, an average of 1.9 each.
Of those 475 companies, 340 also hold records in five or more markets (72%), which says that a substantial part of the Chinese cohort entering South Korea is pursuing a multi-market strategy rather than a single market.
Registered at home as well
Of those 475 companies, 183 also have a Chinese registration or filing in this database (39%).
A share below 100%% has two distinct explanations. Either the company is export-oriented and genuinely holds no domestic registration, or the Chinese side of this database groups by company name and a different spelling — an abbreviation, bracketed suffix or former name — fails to match. The second is a limitation of our data and is not evidence that a company lacks domestic registration.
Chinese companies with the most records
| Company | GMP quality-system certificates | China registrations |
|---|---|---|
| Smith & Nephew Medical (Shanghai) Limited | 16 | 1 |
| Bain Medical Equipment (Guangzhou) Co., Ltd. | 13 | 16 |
| GE HealthCare | 13 | 0 |
| Siemens Healthineers Ltd. | 12 | 32 |
| Guangdong Transtek Medical Co.,Ltd | 11 | 20 |
| Well Lead Medical Co., Ltd. | 11 | 104 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 10 | 892 |
| APT Medical | 10 | 0 |
| Feellife Health Inc. | 9 | 22 |
| HOLOGIC | 9 | 0 |
| Shenzhen Dymind Biotechnology Co.,Ltd. | 8 | 0 |
| Huizhou Foryou Medical Devices Co., Ltd. | 7 | 0 |
Scope and limits
South Korea counts GMP quality-system certificates. this is a pre-market quality-system certification, not per-device registration.
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.
Related
Related: All markets side by side · Chinese companies · Browse by category · Methodology.
This database; source data from MFDS