South Korea Medical Device Registry Statistics
Aggregated from 197,939 official MFDS license records. Data as of 2024-08-20.
The Ministry of Food and Drug Safety (MFDS) regulates medical devices in South Korea. As of 2024-08-20, this registry snapshot contains 197,939 license records, of which 170,103 are currently active and 27,836 are cancelled, expired, or withdrawn.
The registry lists 12,245 distinct license holders.
Every figure on this page is computed from the official registry snapshot. Browse individual records in the searchable South Korea device database, or see our methodology for how the data is collected.
New Licenses by Year
| Year | New licenses |
|---|---|
| 2024 | 4,235 |
| 2023 | 5,008 |
| 2022 | 6,761 |
| 2021 | 7,059 |
| 2020 | 8,183 |
| 2019 | 8,268 |
| 2018 | 7,745 |
| 2017 | 8,308 |
| 2016 | 8,236 |
| 2015 | 9,247 |
| 2014 | 12,612 |
| 2013 | 11,162 |
Licenses by Device Type
| 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
About this data: statistics are computed from the official Ministry of Food and Drug Safety registry as mirrored in the Pure Global database (197,939 records, newest registration dated 2024-08-20; page generated 2026-08-05). “Active” excludes cancelled, expired, and withdrawn records.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. See methodology.