PProcess · Timeline · Cost
Medical Device Registration in South Korea — Timelines, Costs, and Required Documents by Class.
How long registration takes depends on the class. A Class 1 notification normally runs 2–4 weeks (from checking the product data through to filing and acceptance), Class 2 certification 3–4 months, Class 3 approval 6–8 months, and Class 4 approval 9–12 months; where clinical trial data has to be submitted it can take 12–18 months or more. Cost separates into the statutory fee paid to the government and the agency fee, and both are published in the table below. Testing fees and audit body charges are billed separately at actuals, by item.
Last updated: 2026-07-23 · Statutory fee basis: Enforcement Rule of the Medical Devices Act [Annex 10] · amended 1 July 2026 · electronic filing basis
P-01Summary Table
Timelines and costs by class, at a glance
The typical duration covers the whole run from preparing materials to confirming the outcome; the statutory processing period covers the review after filing. The FAQ below explains why the two numbers differ.
| Class · Pathway | Typical duration | Statutory period | Statutory fee | Agency fee |
|---|---|---|---|---|
| Class 1 Notification | Normally 2–4 weeksCovers the whole run — product data check, drafting and remedying the notification documents, filing, and acceptance | 5 daysFrom filing to acceptance | KRW 85,000 | from ₩2.0M |
| Class 2 Certification | Normally 3–4 monthsCertification procedure only · testing and other preparation is separate, by item | — | KRW 130,000 | from ₩6.0M |
| Class 3 Approval | Normally 6–8 monthsApproval procedure only · testing and other preparation is separate, by item | — | KRW 719,000 | from ₩9.0M |
| Class 4 Approval | Normally 9–12 monthsThe usual case, with test data, technical file, and GMP prepared in parallelWhere clinical trial data must be submitted, it normally takes 12–18 months or more; where a new clinical trial has to be run, 18–30 months or more. | 65 days / 80 days65 days for technical file review · 80 days where clinical trial data is included | KRW 719,000KRW 1,495,000 when clinical data review is included | from ₩15.0M |
Typical durations can extend where deficiencies arise. The statutory period covers the review after filing.
Statutory fees are Enforcement Rule of the Medical Devices Act [Annex 10] · amended 1 July 2026 · electronic filing basis; agency fees are minimums (“from”) and are fixed by itemised quotation according to the product and the state of your documentation.
P-02Classification
How is the class decided?
Korea sorts medical devices into four classes, from Class 1 to Class 4, according to the potential risk they pose to the human body. As the class rises the procedure grows heavier too: notification (Class 1) → certification (Class 2) → approval (Class 3 and 4).
Item classification follows the MFDS notice, and which item and class a given product falls under determines the whole procedure, timeline, and cost. Even within the same product family the class can differ according to intended use or specification, so confirming the item classification early in development or import planning matters.
P-03Process
What order does the procedure run in?
Regardless of class, it runs in five stages from pre-review through issuance and post-market management. Select a class below to see the expected pathway, duration, and key documents.
CP-00Self-check
Which procedure applies to my product?
Choose your product's class and you can preview the likely approval pathway and procedure in advance. It's fine if you aren't sure of the class.
The procedures, timelines, and documents above are general examples and can vary depending on the product type, product characteristics, and when regulations are amended. They reflect a practical sense of timing based on how ready your materials are, and may differ from the government's statutory processing periods. For an accurate assessment, please confirm through consultation.
The scope of what we handle and the fee for each item are set out on the regulatory consulting page.
P-04Cost Structure
Why does the cost differ from quotation to quotation?
Registration cost splits into four items. Most of the gap between quotations comes down to which of these were included and which were left out.
Fixed · published
Government statutory fee
The fee paid to MFDS (Korea Medical Device Safety Information Institute). The amount is published in the statutes, so it is the same whichever consultancy you go through.
KTL·KTR published rates
Audit body charges
Paid directly to the bodies that carry out Class 2 technical file review and the KGMP audit, according to each body's published rates.
Calculated by item
Testing fees
Paid at actuals to the testing house. It varies with the item and the set of tests required, and it is the line where quotations diverge most.
Published fee table
Agency fee
What the consultancy charges. CLARE Partners publishes its fee table by item and itemises the four lines above separately in every quotation.
P-05Documents
Required document checklist
This is the general scope of preparation. The detailed requirements shift with the item and product characteristics, so the exact list is fixed at the pre-review stage.
Common (all classes)
- Manufacturing or import business licence — including facility and quality manager requirements
- Basic corporate documents
- Product specification and intended use materials
- Labelling materials
Additional by class (Class 2 and above)
- Technical file — evidence of performance and safety
- Test reports
- KGMP-related materials
- Class 3 and 4: clinical evaluation or clinical trial data where required
Additional for imports
- Overseas manufacturer supporting documents
- Overseas site GMP (import GMP) materials
- Overseas test and certification data — reviewed for whether it can be reused
P-06Variables
Three variables that stretch the timeline
Within the same class, what separates the actual duration is usually one of the three below.
Variable 01
Repeated deficiencies
Every round of deficiencies during review adds its own response and re-review time. Reviewing the internal consistency of your materials before filing, to reduce the chance of deficiencies, is the practical way to shorten the schedule.
Variable 02
Retesting
Where test results fall short of the standard, or the set of tests was designed wrongly, the testing has to be run again. Fixing the test set for the item early on matters.
Variable 03
Overseas site KGMP in parallel
KGMP is a separate track run per manufacturing site, and it can proceed in parallel with the item review. For a new site, KGMP readiness becomes the main variable in the overall schedule.
FAQQuestions
Frequently asked questions
If the statutory processing period for a Class 1 notification is 5 days, why do you quote 2–4 weeks?
The 5 days is the statutory processing period from filing to acceptance. In practice you also need the preparation stage — checking the product data, drafting and remedying the notification documents, and filing — so on a whole-run basis we quote 2–4 weeks.
If the statutory processing period for Class 4 approval is 65–80 days, why 9–12 months?
The 65 days (technical file review) and 80 days (where clinical trial data is included) are statutory processing periods for the review after filing. They exclude the preparation of test data, technical file, and GMP before filing, and the deficiency periods during review — so for the usual case where preparation runs in parallel we quote 9–12 months. Where clinical trial data must be submitted it normally takes 12–18 months or more, and where a new clinical trial has to be run, 18–30 months or more.
Is the KGMP audit period included here?
It is not. KGMP is a separate procedure run per manufacturing site and can proceed in parallel with the item review. For a new site, KGMP becomes the main variable in the overall schedule.
What are the Class 2 and 3 durations based on?
They are typical durations centred on the certification or approval procedure — filing, review, and deficiency responses. Preparation such as testing varies by item and is calculated separately.
Why does the cost differ from quotation to quotation?
Cost splits into four: the government statutory fee (fixed and published), audit body charges (KTL, KTR and others, at published rates), testing fees (by item), and the agency fee. Of these, what varies with the item is the testing fee and the agency fee — so compare quotations that itemise the lines separately.
Is there any way to bring the timeline forward?
The largest source of delay is repeated deficiencies during review. Reviewing the internal consistency of your materials before filing, to reduce the chance of deficiencies, is the practical way to shorten it.
Just send the product details.
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