Korean Medical Device Registration Costs: Official Fees and Service Fees

1. Key takeaways

Korean registration costs fall into two blocks, official fees and service fees, whose certainty differs completely. Official fees are charged by class and by whether clinical data is required: KRW 85,000 for Class 1; KRW 2,400,000 initially and KRW 1,800,000 for changes for Class 2; KRW 561,000 without clinical data and KRW 1,338,000 with clinical data for Class 3 and Class 4. This is the part that can be looked up, verified and budgeted.

• Service fees include the licence holder annual fee, translation fees and consultancy fees; all are market-priced with no statutory standard and must be treated as a practical estimate throughout.
• GRZAN’s budgeting practice is to keep the two blocks separate: official fees are entered per the statutory schedule, while service fees are listed per the project’s actual quotation and marked as a practical estimate.
• Two further items must be budgeted separately: the item renewal fee (statutorily required to be paid, with the specific amount governed by the current fee schedule) and the liability compensation insurance premium (a commercial insurance expense, a practical estimate).
• Class alone does not determine the total cost; workload, licence holding and quality system spending must be estimated as separate components.

2. Legal basis

The official fees and the renewal payment obligation rest on the following instruments, traceable through the regulation names, document numbers, publication dates and provisions listed below.

3. Expert insights

Insight 1: Official fees and service fees must be listed in separate tables; merging them inevitably distorts the budget. Folding the official review fees and the service fees into one total makes the budget unverifiable at review. GRZAN’s practice is two sheets: one contains only statutory figures, traceable to the Enforcement Rule attached table; the other lists service items, each marked as a practical estimate with its quotation source. The benefit appears at internal client approval: the statutory part needs no explanation, and the service part is negotiated separately.

Insight 2: Class does not determine the level of total cost. The official fee of KRW 2,400,000 for Class 2 is the highest among the four classes, yet Class 3 and Class 4 projects usually carry a higher total cost, because the workload of dossier preparation, clinical data and audit support is larger. Back-deriving project budgets from official fees alone produces the wrong conclusion. GRZAN recommends estimating three components separately: official fees, dossier preparation workload, and licence holding and quality system costs.

Insight 3: The licence holder annual fee is a recurring item, not a one-off. The licence holder annual fee accrues yearly and persists as long as the licence remains valid; it is a practical estimate, varying with service scope and entity type. Over the 5-year item renewal cycle, the licence holding fee recurs more than 5 times. Treating it as a one-off investment is the most common cause of under-budgeting.

Insight 4: Translation fees correlate with dossier volume and can be controlled at the dossier stage. Translation fees are a practical estimate, directly related to technical document length, the number of models and the complexity of the instructions for use. Reducing the number of applications through item group consolidation and cutting repeated translation through a document master are controllable cost levers, unlike the official fees, which are charged per application and leave limited room for optimisation (specific optimisation paths are covered in a dedicated article). Spending more time at the dossier stage on master documents and item group planning often lowers the total cost more than pushing unit prices down at the negotiation stage.

4. Practical recommendations

• Prepare the budget in two blocks. Enter official fees per the Enforcement Rule attached table; list service fees separately and mark them as a practical estimate.
• Project licence holding and renewal costs over a 5-year cycle. The licence holder annual fee (practical estimate) accrues yearly and the item renewal fee is payable; both belong in the long-term budget.
• Confirm the class and the clinical data requirement to fix the official fee tier. KRW 1,338,000 with clinical data and KRW 561,000 without clinical data for Class 3 and Class 4; a wrong tier determination leads directly to a wrong payment.
• Include the liability compensation insurance premium in pre-market costs. For applicable products the premium is a commercial insurance expense (practical estimate) and should be quoted in advance.
• Control translation costs at the dossier stage. Item group consolidation and document masters reduce repeated translation more effectively than negotiating prices afterwards.

5. Verification checklist

• □ Class determination: check against Article 3 and Attached Table 1 of the Enforcement Rule; the class conclusion is traceable.
• □ Clinical data requirement: judge the dossier composition and clinical need; the official fee tier is determined correctly.
• □ Official fee amounts: check the Enforcement Rule attached table by class; KRW 85,000 for Class 1; KRW 2,400,000 initially and KRW 1,800,000 for changes for Class 2; KRW 561,000 and KRW 1,338,000 for Class 3 and Class 4.
• □ Service fee presentation: check whether the budget sheet lists them separately; licence holder annual fee, translation fees and consultancy fees are all marked as a practical estimate.
• □ Long-term cost projection: project over the 5-year renewal cycle; includes the licence holding annual fee and the renewal fee.
• □ Insurance cost: determine the applicability of the liability compensation insurance and obtain quotes; the premium is in the budget and marked as a practical estimate.
• □ Currency and payment timing: check the payment notices and payment receipts; amounts are charged in KRW and receipts are archived.
• □ Regulatory information verified as of 29 October 2026 (pending verification for any later amendments).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, Korean licence holder and local testing support for the Republic of Korea. Our team coordinates licence holder arrangements, import business registration, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com