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 It used to be a 10-day review. The Enforcement Rule amendment that took effect on 8 April 2012 converted Class I from a reviewed notification into acceptance-on-filing Filed to the Korea Institute of Medical Device Safety Information through the e-Medis portal, not to a regional MFDS office A Class I device that is not substantially equivalent to anything already authorised is pushed out of the notification route and into full approval (Enforcement Rule Art. 4) | 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 Korea counts a period of 5 days or less in hours from the moment of receipt, excluding Saturdays and public holidays, so this is a working-day figure Certification is delegated to the Korea Institute of Medical Device Safety Information rather than performed by MFDS itself Some Class II devices are carved out of certification and sent to full MFDS approval instead: combination products with a drug or quasi-drug, u-Health devices, continuously worn respiration monitors under tracking management, daily-wear hard and soft contact lenses, devices in the joint device-approval/new-health-technology process, devices that are not substantially equivalent or need clinical data, and devices whose sub-classification has not been published | 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 MFDS bands the approval clock by how much review the dossier needs, not by risk class — the same 10/65/80 ladder governs Class III and IV items and the minority of Class I and II items that are pushed into the approval route | 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 A preliminary review runs first; where the attachments do not meet the requirements the applicant gets 5 days to supply what is missing Periods of 6 days or more are counted in days from the date of receipt, excluding Saturdays and public holidays | 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 Same 5-day supplement window at preliminary review as the technical-document route The clinical study itself sits outside this clock entirely | 80 working days | 10-15 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
South 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.
- 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
Reviewed 2026-08-30. End-to-end totals remain planning estimates.