MFDS current fee schedule, reviewed for 2026, in KRW.
21 fee lines100% exact amountscurrency KRWFX rates 2026-09-24reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Product application without technical review | KRW 158,000–176,000 | $116–$129 | Per application | Verified |
| Product application with technical documents | KRW 719,000–799,000 | $527–$585 | Per application | Verified |
| Product application with clinical data | KRW 1,495,000–1,662,000 | $1,095–$1,218 | Per application | Verified |
| Separate technical-document evaluation | KRW 561,000–624,000 | $411–$457 | When applicable | Verified |
| Separate technical-document and clinical-data evaluation | KRW 1,338,000–1,488,000 | $980–$1,090 | When applicable | Verified |
| Manufacturing/import business licence application | KRW 144,000–160,000 | $106–$117 | Per application | Verified |
| Innovative medical device (신개발의료기기) approval including technical-document review Components: technical-document review KRW 55,240,000 and clinical-data review KRW 39,170,000; approval excluding technical-document review KRW 4,020,000. Pre-review fees are deductible from the approval fee when the pre-review result is adequate. | KRW 98,430,000 | $72,122 | Per approval | Verified |
| Approval renewal | KRW 500,000–520,000 | $366–$381 | Per renewal | Verified |
| Certification application | KRW 130,000–145,000 | $95.25–$106 | Per application | Verified |
| Certification renewal | KRW 430,000–450,000 | $315–$330 | Per renewal | Verified |
| Notification | KRW 85,000–96,000 | $62.28–$70.34 | Per notification | Verified |
| Notification renewal | KRW 100,000 | $73.27 | Per renewal | Verified |
| Change approval - documents and clinical review | KRW 1,009,000–1,122,000 | $739–$822 | Per application | Verified |
| Change approval - document review | KRW 551,000–612,000 | $404–$448 | Per application | Verified |
| Change certification | KRW 80,000–98,000 | $58.62–$71.81 | Per application | Verified |
| Change notification | KRW 38,000–48,000 | $27.84–$35.17 | Per notification | Verified |
| Post-market survey result review | KRW 90,000–100,000 | $65.95–$73.27 | Per review | Verified |
| Sales/rental business notification | KRW 8,000–10,000 | $5.86–$7.33 | Per notification | Verified |
| English certificate | KRW 21,000–24,000 | $15.39–$17.59 | Per certificate | Verified |
| Permit/certificate reissue | KRW 2,200–3,400 | $1.61–$2.49 | Per reissue | Verified |
| Technical-document pre-review Documents plus clinical review starts from KRW 1,097,000 (second column unclear in the source annex). | KRW 524,000–583,000 | $384–$427 | Per review | Verified |
Government fees only — service and testing costs are separate- The payable combination depends on whether technical or clinical review is required.
- The MFDS Enforcement Rule annex [별표 10] publishes two tariff columns per row (column headers are not legible; likely electronic vs paper filing) — ranges show both columns.
- KGMP conformity-assessment on-site review fees are set by the quality-management review body with MFDS approval and are not listed here.
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Exact amounts verified against the MFDS fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:south-korea:product-application-without-technical-review