GuidelinesBy procedure2026.09.25
Medical Device Registration Fees and Statutory Deadlines in Korea — One-Page Table for Classes 1–4, Business Licences, KGMP, and Renewal
How much goes to the government, and how many days does the law allow? The scattered numbers gathered on one page — item notification, certification, and licence fees by class, manufacturing and import business licence and sales notification fees, renewal fees, the statutory notice periods and the “deemed granted if no notice” rule, and the validity periods of licences and KGMP conformity. Also how a quotation splits between statutory fees, third-party costs, and consulting fees.
Key takeaway — Statutory fees paid to the government are set by Annex 10 of the Enforcement Rule of the Medical Devices Act: KRW 85,000 for a Class 1 notification, 130,000 for a Class 2 certification, 719,000 for a Class 3 or 4 licence (1,495,000 where clinical data review is included), 144,000 each for a manufacturing or import business licence, 10,000 for a sales (rental) business notification, and 500,000 / 430,000 / 100,000 for renewal of a licence / certification / notification (e-filing rates). The statutory notice periods are 25 days for manufacturing and import business licences, 15 days for a manufacturing business change licence, and 3 days for a sales notification, and where no notice is given within the period the application is deemed granted or accepted the following day. Licences, certifications, and notifications are valid for five years; KGMP conformity for three. The large numbers on a quotation come not from statutory fees but from review body fees, testing charges, and consulting fees.
What goes to the government — statutory fees on one page
Statutory fees are set in Annex 10 of the Enforcement Rule, at the rates that apply to electronic filing. The table below has the same source as the fee schedule published under the price list on our regulatory consulting services page.
| Item | Statutory fee | Note |
|---|---|---|
| Class 1 manufacturing or import notification | KRW 85,000 | Per item |
| Class 2 manufacturing or import certification | KRW 130,000 | Technical document review body fee billed separately at cost |
| Class 3 or 4 manufacturing or import licence | KRW 719,000 | Includes technical document review. KRW 1,495,000 where clinical data review is included |
| Manufacturing business licence · import business licence | KRW 144,000 each | Company level; applied for together with at least one item |
| Sales (rental) business notification | KRW 10,000 | Per place of business |
| Renewal of a licence · certification · notification | KRW 500,000 · 430,000 · 100,000 | In that order |
The fees are paid to the MFDS (certifications and notifications via the National Institute of Medical Device Safety Information). Two things are not in this table. The fees for the Class 2 technical document review and the KGMP audit follow the published rates of the review bodies (KTL, KTR, and others) and are billed at cost, and testing charges are set separately by the testing laboratory by item and test. Veterinary devices follow a different statute and a different table (a flat KRW 10,000 per item) — see the veterinary medical device guide.
What the law sets as deadlines — notice periods and the “deemed granted” rule
Processing time has two layers: the notice periods the Act itself fixes, and the item review periods set by Ordinance and civil-petition processing standards. The first has numbers in the statute; the second varies by class and by the state of the dossier.
| Procedure | Statutory notice period | If no notice within the period | Basis |
|---|---|---|---|
| Manufacturing business licence | 25 days from application | Deemed granted on the day after the period ends | Medical Devices Act, Article 6(8) and (9) |
| Import business licence | 25 days (manufacturing provisions applied) | Same | Article 15(6) |
| Manufacturing business change licence | 15 days | Same | Article 12(2) and (3) |
| Sales or rental business notification | 3 days | Deemed accepted on the day after the period ends | Article 17(4) and (5) |
| Class 1 manufacturing notification | — | Accepted after review where it conforms to the Act | Article 6(10) |
The “deemed granted if no notice” rule is measured against the extended period where the processing period has been extended under civil-petition legislation. In other words, a request for supplementary documents restarts the clock. What takes time in practice is not this notice period but the preparation and supplementation before it.
The felt duration of the item review differs by class — about 2 to 4 weeks for a Class 1 notification, about 3 to 4 months for a Class 2 certification, about 6 to 8 months for a Class 3 licence, and more than a year for Class 4. Those figures are practical benchmarks for a complete dossier, not fixed periods, and are laid out with the documents for each class in timelines and costs.
How long it lasts — validity periods
| What | Validity | Renewal | Basis |
|---|---|---|---|
| Manufacturing or import licence, certification, or notification | 5 years from the date granted or accepted | Before expiry, with a statutory fee | Article 49(1) and (3) |
| Devices subject to post-market surveillance | 5 years from completion of the surveillance review | Same | Article 49(2) |
| KGMP conformity recognition | 3 years from issue of the certificate | Obtained again before expiry | Article 28(3) and (4) |
| Post-market surveillance of newly developed devices | 4 to 7 years as a condition of the licence | — | Article 8(1) |
Starting a renewal just before expiry is too late. The filing window and the documents are in the renewal guide, and the full set of duties that continue after approval is in what starts after approval.
Where a quotation's numbers come from — four layers of cost
The statutory fee is KRW 130,000 and the quotation runs to millions because the cost has four layers.
| Layer | What | Paid to | In this article's table? |
|---|---|---|---|
| ① Statutory fees | The Annex 10 amounts above | MFDS / the Institute | Yes |
| ② Review body fees | Class 2 technical document review, KGMP audit | Review bodies at published rates (at cost) | No — varies by body |
| ③ Testing charges | Electrical safety, EMC, biocompatibility, performance tests | Testing laboratories (at cost) | No — varies by item |
| ④ Consulting fee | Dossier preparation, correspondence, schedule management | The agent | No — per contract |
When you compare quotations, first check that all four layers are written down. If any layer is left as “separate”, the totals cannot be compared. The Class 2 structure is broken down item by item in why Class 2 certification quotations differ, and the cost difference between doing a Class 1 notification yourself and using an agent is in Class 1 notification: do it yourself or outsource?.
Common mistakes
- Reading the statutory fee as the total cost — from Class 2 upward, ② and ③ are larger than ①
- Reading the notice period as a completion deadline — a request for supplements extends the processing period, and the deemed-granted rule follows the extended period
- Letting the five-year validity lapse unnoticed — without renewal before expiry, manufacturing or import cannot continue
- Managing KGMP (3 years) and the licence (5 years) on one clock — the cycles differ, so keep separate deadline schedules
- Using the human-use table for veterinary devices — the statute and the payee differ
Before you start
- You have identified your device's class and the matching statutory fee row
- You have checked that the quotation lists all four layers — statutory fees, review body fees, testing charges, consulting fee
- You have scheduled the company-level licence (manufacturing or import business) together with the item procedure
- You have entered the five-year licence expiry and the three-year KGMP expiry on separate deadline schedules
- For a veterinary device, you have checked the veterinary table, not the human-use one
The numbers fit on one page, but which row applies to your product and how much is added at cost differs by item. Send us the product specification, your estimated class, and a list of the test reports you hold, and we will give you the statutory fees and an expected range for third-party costs within one business day — through a free pre-review.
Legal basis: Medical Devices Act of Korea (Act No. 21949, in force 15 Sep 2026) — Article 6 (Licence for Manufacturing Business, etc.), paragraphs 8–10 · Article 8 (Post-Market Surveillance of Newly Developed Devices, etc.) · Article 12 (Change Licences, etc.) · Article 15 (Licence for Import Business, etc.), paragraph 6 · Article 17 (Notification of Sales Business, etc.), paragraphs 4 and 5 · Article 28 (Conformity Recognition of Manufacturing and Quality Management Systems) · Article 49 (Renewal of Manufacturing Licences, etc.), texts confirmed on 22 Sep 2026 in the National Law Information Center. Fee amounts: Enforcement Rule of the Medical Devices Act, Annex 10 (amended 1 Jul 2026, e-filing rates), as confirmed on 20 Jul 2026; they may change when the Annex is amended. Felt durations are practical benchmarks, not statutory processing periods.
Frequently asked questions
- Q. The Class 2 certification fee is KRW 130,000 — why are quotations in the millions?
- KRW 130,000 is the statutory fee paid to the MFDS (via the National Institute of Medical Device Safety Information). For Class 2, on top of that come the technical document review body's fee, the testing laboratory's charges, and the KGMP audit fee, each billed at cost, plus a consulting fee if you use an agent. The differences between quotations usually come down to which of those four items were included and which were left out.
- Q. What happens if there is no decision within the deadline after we apply?
- For a manufacturing business licence the MFDS must notify its decision within 25 days of the application, and if neither a decision nor a notice extending the processing period is given within that period (or the extended period), the licence is deemed granted on the day after the period ends (Medical Devices Act, Article 6(8) and (9)). The same provisions apply to import business licences (Article 15(6)). For sales and rental business notifications the deadline is three days, with the same deemed-acceptance rule (Article 17(4) and (5)).
- Q. Once granted, does an approval last indefinitely?
- No. A manufacturing or import licence, certification, or notification is valid for five years, and renewal must be obtained before expiry to continue manufacturing or importing (Article 49(1) and (3)). Renewal carries its own statutory fee. KGMP conformity recognition is separate: it is valid for three years from the date the certificate is issued and must be renewed before it expires (Article 28(3) and (4)).
- Q. Do veterinary devices pay the same fees?
- No. Veterinary devices fall under the Rules on the Handling of Veterinary Drugs, the fees are paid to the Animal and Plant Quarantine Agency, and the item licence fee is a flat KRW 10,000 per item regardless of class. The table differs from Annex 10 for human-use devices, so do not mix the two. Veterinary procedures are covered in a separate guide.