MFDS official fee source and current amount-availability status.
21 fee lines100% exact amountscurrency KRWFX rates 2026-11-09reviewed 2026-10-21
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Product application without technical review Standard manufacturing/import approval application, excluding newly developed devices (MD Annex 10 item 3; IVD Annex 3 item 3). Base tariff: electronic application KRW 158,000; visit/post application KRW 176,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item3(c) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row. | KRW 158,000–176,000 | $116–$129 | Per application | Verified |
| Product application with technical documents Standard manufacturing/import approval application, excluding newly developed devices (MD Annex 10 item 3; IVD Annex 3 item 3). Base tariff: electronic application KRW 719,000; visit/post application KRW 799,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item3(b) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row. | KRW 719,000–799,000 | $528–$587 | Per application | Verified |
| Product application with clinical data Standard manufacturing/import approval application, excluding newly developed devices (MD Annex 10 item 3; IVD Annex 3 item 3). Base tariff: electronic application KRW 1,495,000; visit/post application KRW 1,662,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item3(a) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row. | KRW 1,495,000–1,662,000 | $1,098–$1,221 | Per application | Verified |
| Separate technical-document evaluation Base tariff: electronic application KRW 561,000; visit/post application KRW 624,000. The displayed span distinguishes filing channels, not an uncertainty range. This review approves this tariff for medical devices only. IVD applicability has not been approved for this row from the cited originals. | KRW 561,000–624,000 | $412–$458 | When applicable | Verified |
| Separate technical-document and clinical-data evaluation Base tariff: electronic application KRW 1,338,000; visit/post application KRW 1,488,000. The displayed span distinguishes filing channels, not an uncertainty range. This review approves this tariff for medical devices only. IVD applicability has not been approved for this row from the cited originals. | KRW 1,338,000–1,488,000 | $983–$1,093 | When applicable | Verified |
| Manufacturing/import business licence application Manufacturing/import business licence application; this is an establishment transaction, not a per-product approval fee. Base tariff: electronic application KRW 144,000; visit/post application KRW 160,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item1 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row. | KRW 144,000–160,000 | $106–$118 | Per application | Verified |
| Newly developed medical device (신개발의료기기) approval including technical-document review This tariff covers legally defined newly developed devices (신개발의료기기). MD Annex 10 item 3-2(b) separately lists technical-document review KRW 55,240,000 and clinical-data review KRW 39,170,000; item 3-2(c) lists approval excluding those reviews at KRW 4,020,000. The MD Annex 10 footnote permits deduction of item 19 pre-review fees only where the newly developed-device pre-review result is suitable; IVD Annex 3 does not itself repeat this deduction rule. Base tariff: electronic application KRW 98,430,000; visit/post application KRW 98,430,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item4(a) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row. | KRW 98,430,000 | $72,300 | Per application | Verified |
| Approval renewal Base tariff: electronic application KRW 500,000; visit/post application KRW 520,000. The displayed span distinguishes filing channels, not an uncertainty range. This review approves this tariff for medical devices only. IVD applicability has not been approved for this row from the cited originals. | KRW 500,000–520,000 | $367–$382 | Per renewal | Verified |
| Certification application Base tariff: electronic application KRW 130,000; visit/post application KRW 145,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item5 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row. | KRW 130,000–145,000 | $95.49–$107 | Per application | Verified |
| Certification renewal Base tariff: electronic application KRW 430,000; visit/post application KRW 450,000. The displayed span distinguishes filing channels, not an uncertainty range. This review approves this tariff for medical devices only. IVD applicability has not been approved for this row from the cited originals. | KRW 430,000–450,000 | $316–$331 | Per renewal | Verified |
| Notification Base tariff: electronic application KRW 85,000; visit/post application KRW 96,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item6 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row. | KRW 85,000–96,000 | $62.44–$70.52 | Per notification | Verified |
| Notification renewal Base tariff: electronic application KRW 100,000; visit/post application KRW 100,000. The displayed span distinguishes filing channels, not an uncertainty range. This review approves this tariff for medical devices only. IVD applicability has not been approved for this row from the cited originals. | KRW 100,000 | $73.45 | Per renewal | Verified |
| Change approval - documents and clinical review Base tariff: electronic application KRW 1,009,000; visit/post application KRW 1,122,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(a) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row. | KRW 1,009,000–1,122,000 | $741–$824 | Per application | Verified |
| Change approval - document review Base tariff: electronic application KRW 551,000; visit/post application KRW 612,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item7(b) independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row. | KRW 551,000–612,000 | $405–$450 | Per application | Verified |
| Change certification Base tariff: electronic application KRW 82,000; visit/post application KRW 93,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item8 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row. | KRW 82,000–93,000 | $60.23–$68.31 | Per application | Verified |
| Change notification Base tariff: electronic application KRW 39,000; visit/post application KRW 43,000. The displayed span distinguishes filing channels, not an uncertainty range. The corresponding IVD Annex 3 item9 independently publishes the same two channel amounts. Other IVD transactions are not inferred from this MD tariff row. | KRW 39,000–43,000 | $28.65–$31.59 | Per notification | Verified |
| Post-market survey result review Base tariff: electronic application KRW 90,000; visit/post application KRW 100,000. The displayed span distinguishes filing channels, not an uncertainty range. This review approves this tariff for medical devices only. IVD applicability has not been approved for this row from the cited originals. | KRW 90,000–100,000 | $66.11–$73.45 | Per review | Verified |
| Sales/rental business notification Sales/rental business notification; this is a business transaction, not a per-device/REF charge. Base tariff: electronic application KRW 9,000; visit/post application KRW 10,000. The displayed span distinguishes filing channels, not an uncertainty range. This review approves this tariff for medical devices only. IVD applicability has not been approved for this row from the cited originals. | KRW 9,000–10,000 | $6.61–$7.35 | Per notification | Verified |
| English certificate Base tariff: electronic application KRW 21,000; visit/post application KRW 24,000. The displayed span distinguishes filing channels, not an uncertainty range. This review approves this tariff for medical devices only. IVD applicability has not been approved for this row from the cited originals. | KRW 21,000–24,000 | $15.43–$17.63 | Per certificate | Verified |
| Permit/certificate reissue Base tariff: electronic application KRW 2,100; visit/post application KRW 2,400. The displayed span distinguishes filing channels, not an uncertainty range. This review approves this tariff for medical devices only. IVD applicability has not been approved for this row from the cited originals. | KRW 2,100–2,400 | $1.54–$1.76 | Per reissue | Verified |
| Technical-document pre-review MD Annex 10 item 18(a), excluding newly developed devices. Distinct documents-plus-clinical pre-review item 18(b) is KRW 1,097,000 electronic / KRW 1,219,000 visit-post; newly developed-device pre-review is a separate item 19 tariff. Base tariff: electronic application KRW 524,000; visit/post application KRW 583,000. The displayed span distinguishes filing channels, not an uncertainty range. This review approves this tariff for medical devices only. IVD applicability has not been approved for this row from the cited originals. | KRW 524,000–583,000 | $385–$428 | Per review | Verified |
Government fees only — service and testing costs are separate- The 21 listed medical-device tariffs were individually rechecked on 21 October 2026 against Medical Devices Act Enforcement Rule Annex 10. Coverage is limited to the listed transactions.
- The two tariff columns mean electronic application and visit/post filing. The primary amount shown is the electronic tariff; displayed spans distinguish filing channels.
- IVD Annex 3 independently confirms the 11 corresponding transactions identified in the row notes. The other 10 listed tariffs have been verified here for medical devices; their IVD applicability requires separate confirmation.
- No universal low/high risk fee band is presented. KRW 158,000 is the ordinary permit application without technical review; it does not establish the fee for Class I notifications or all low-risk devices. Use the named transaction and its filing channel to determine the relevant base tariff.
- These are base transaction tariffs. Eligible statutory exemptions or reductions under MD Rule Article 65 or IVD Rule Article 41 may apply; a fee row does not establish a payable total for every named change or every device.
- The live e-Medis technical-document-change-evaluation line is KRW 449,000/499,000, while MD Annex 10 item6(d) publishes KRW 430,000/478,000. This unresolved portal/annex identity/tariff difference concerns a separate transaction outside these 21 rows and is not harmonised into a universal change fee.
- KGMP conformity-assessment review and on-site costs are separately set by the quality-management review body with MFDS approval (MD Annex 10 item 21); no universal amount is invented here.
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Listed amounts verified individually; a universal registration fee is not asserted · full review 2026-10-21 · row IDs are stable — cite as government-fees:south-korea:product-application-without-technical-review