South Korea medical device registration timeline
Source-linked clocksMinistry of Food and Drug Safety (MFDS) review clocks and end-to-end planning ranges, using the 4-class (I, II, III, IV) classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I (1등급)(Manufacture/import notification (제조·수입 신고)) The Government24 service record puts the processing period at 즉시 — immediate, within 3 working hours — so this is a same-day filing rather than a review | 0 days | 0 days | — | Verified |
| Class II (2등급)(Certification (인증) by the Korea Institute of Medical Device Safety Information) Five days is the certification decision only. The technical-document review that must precede it is a separate application to a designated review body, and the K-GMP conformity assessment is separate again — those are what make the practical elapsed time months rather than a week | 5 working days | 3-6 months | — | Verified |
| Approval — no technical-document review(MFDS approval (허가)) Applies where no technical-document review is needed: export-only approvals whose intended use has been checked, and items proven identical to an already approved product | 10 working days | 10-20 working days | — | Verified |
| Approval — technical-document review(MFDS approval (허가)) The standard route for a Class III or IV device that does not need clinical data | 65 working days | 6-12 months | — | Verified |
| Approval — clinical data review(MFDS approval (허가)) Applies wherever clinical trial data has to be assessed, which in practice is most Class IV devices and the novel end of Class III | 80 working days | 10-15 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesSouth Korea Medical Device Registration Process
Step-by-step MFDS registration process. Total estimated timeline: 0 days.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by MFDS. Appoint a Korea License Holder.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to MFDS including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksMFDS reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. MFDS may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, MFDS issues South Korea market authorization certificate.
Summary: The South Korea medical device registration process through Ministry of Food and Drug Safety (MFDS) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
FDA 510(k)No direct recognitionNone
EU CE MarkNo direct recognitionNone
MDSAPCan waive on-site K-GMP audit2-3 months
Key requirements
- Korea License Holder (for foreign manufacturers)
- Establishment licence first: the manufacturer/importer licence takes 25 days and must be applied for together with at least one product approval, certification or notification, as a combined application
- K-GMP certification (Class II-IV)
- Korean labeling
- Local testing from accredited labs
- The route is set by class and by review need: Class I notifies (immediate), Class II is certified by the Korea Institute of Medical Device Safety Information (5 days), Class III and IV are approved by MFDS (10, 65 or 80 days depending on whether technical documents or clinical data must be reviewed)
- Change approvals: within 42 days (no clinical data) or 60 days (clinical data needed), and 10 days where no review is required; preliminary-review supplements within 5 days
- Renewal filing window: 270 to 180 days before the authorisation expiry date
MDSAP: Can waive on-site K-GMP audit
Primary regulator sources
gov.kr · Government24 service record — medical device manufacture/import notification (의료기기 제조(수입)(변경) 신고), processing period 즉시 / within 3 working hours gov.kr · Government24 service record — medical device manufacture/import certification (의료기기 제조(수입)인증), processing period 5 days at the Korea Institute of Medical Device Safety Information gov.kr · Government24 service record — medical device manufacture/import approval (의료기기제조(수입)허가), processing period 10 / 65 / 80 days by review type gov.kr · Government24 service record — medical device manufacturer/importer establishment licence (의료기기 제조(수입)업 허가), processing period 25 days emedi.mfds.go.kr · MFDS e-Medis — approval procedure flowcharts and processing periods (허가 절차)
Reviewed 2026-08-30. End-to-end totals remain planning estimates.
Keep researching this market
More South Korea medical device resources
Continue with this market
Source-linked review clocks verified against MFDS publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:south-korea:class-i