South Korea Medical Device Registry Statistics
Aggregated from 197,939 official MFDS license records. Data as of 2024-08-20.
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Licenses by Device Type
Largest device type groups among active licenses
| Device Type | Licenses | Share |
|---|---|---|
| Spectacle lenses | 4,059 | 2.4% |
| Splint | 2,932 | 1.7% |
| Spectacle lenses for vision correction | 2,553 | 1.5% |
| Compression bands | 2,326 | 1.4% |
| Airway Hearing Aids | 2,233 | 1.3% |
| Manual bone surgery machine | 2,029 | 1.2% |
| Medical cutting instruments | 1,582 | 0.9% |
| Dental Implant Instruments | 1,579 | 0.9% |
| High-risk infection immunoassay reagent | 1,551 | 0.9% |
| Clinical Examination Universal Quality Control Substance I. | 1,425 | 0.8% |
| Dental Implant Superstructure | 1,350 | 0.8% |
| Reusable medical forceps | 1,325 | 0.8% |
| Genetic testing reagent for high-risk infections | 1,198 | 0.7% |
| Hearing aids (non-implantable) | 1,120 | 0.7% |
| Medical Gloves | 1,023 | 0.6% |
| Manual wheelchair | 1,020 | 0.6% |
| Soft contact lenses for everyday wear | 1,005 | 0.6% |
| Reusable Hand-Operated Medical Opening Device | 913 | 0.5% |
| Other Clinical Chemistry Test Reagents II. | 905 | 0.5% |
| Electric Medical Bed | 882 | 0.5% |
Top 50 License Holders in South Korea
Local license holders ranked by active licenses held. MFDS item licenses are held by Korea-based manufacturers and import businesses.
What the MFDS medical device registry shows
The Ministry of Food and Drug Safety (MFDS) regulates medical devices in South Korea. As of 2024-08-20, this official dataset snapshot contains 197,939 license records, of which 170,103 are currently active and 27,836 are cancelled, expired, or withdrawn. The dataset lists 12,245 distinct license holders.
Every figure is computed from the official dataset snapshot as mirrored in the Pure Global database — “active” excludes cancelled, expired, and withdrawn records.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. 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 South Korea device database, or see our methodology for how the data is collected.