Estimate 2026 Korean Class I-IV notification, certification, or approval fees, project cost, preparation time, launch-delay loss, and recovery units.
Choose the class and evidence route confirmed with MFDS. This calculator does not classify a product.
Estimated route
Class II product certification
Enforcement Rule Articles 4 and 6, Annex 10, and Form 5
For non-statutory items, enter actual laboratory, review-body, and adviser quotes rather than a market average.
Keep cash spending, internal resources, and the opportunity cost of delay separate.
Choose parallel for concurrent work or sequential when each task depends on the previous one.
Planning result
Rule effective date 2026-07-01
Statutory fee
130,000 KRW
After confirmed reduction
Total cost incl. delay
130,000 KRW
Includes internal effort and delay
Estimated total timeline
5 days
0.17 months
Units needed to recover cost
Not available
Based on total cost including delay
The grant offsets external direct cost, while internal labour remains an economic cost.
The business licence and product filing are treated as parallel, using the longer official period.
Official sources checked: 2026-08-09 · One product application per calculation
A Korean medical-device launch budget can look deceptively small when it starts with only the government filing charge.
The more consequential items are often laboratory testing, technical documentation, clinical or performance evidence, quality-system work, outside regulatory support, internal staff time, deficiency responses, and the opportunity cost of a delayed launch.
A Class II product may follow a five-day certification route when no separate review is needed, a sixty-day planning route when separate technical review precedes certification, or an eighty-day approval route when clinical data are required.
This calculator therefore separates the statutory amount that can be anchored to the rules from every company-specific quote and schedule assumption.
It applies the fee schedule effective July 1, 2026 and lets you model one Korean product application at a time.
It is a budgeting and scheduling aid, not a product-classification service, regulatory opinion, filing form, or promise that an application will be accepted.
The Korean Medical Devices Act requires a manufacturer or importer to obtain the relevant business licence and to notify, certify, or obtain approval for each product as applicable.
Article 3 provides the risk-based foundation for classification, while Articles 6 and 15 govern the manufacturing and importing routes.
The Enforcement Rule, including Annex 1, describes Classes I through IV by potential harm, and Articles 4 through 9 establish the product notification, certification, approval, and technical-review structure.
Article 65 and Annex 10 provide the fee schedule used by this calculator.
The filing forms also state processing periods, which are distinct from the time a company needs to generate evidence and prepare a complete dossier.
The current anchors were checked on August 9, 2026 against the versions effective July 1, 2026.
The calculator selects a notification, certification, certification-plus-review, ordinary approval, or new-development integrated-review route from the confirmed class and evidence requirement.
The selection is an estimate based on the inputs, so the user remains responsible for confirming the category and route with MFDS or another competent body.
A new manufacturing or importing business licence is a separate administrative item from the product application.
The model can add its fee and uses the longer of the product and business-licence processing periods because a first product filing can accompany the business-licence application.
Class I generally covers devices with almost no potential harm, Class II covers low potential harm, Class III covers moderate potential harm, and Class IV covers high potential harm.
Where more than one classification could apply, the highest risk class governs.
Classification still depends on the intended use, operating principle, duration and location of contact, raw materials, performance, and the relevant product-category notice.
Two products that appear commercially similar may require different evidence when their intended uses or technical characteristics differ.
Before using the output for a board paper or a financing request, preserve the official classification response or the written analysis that supports the selected class.
| Confirmed condition | Estimated route | Electronic fee | Processing period |
|---|---|---|---|
| Class I with no separate review | Product notification | KRW 85,000 | 5 days |
| Class II with no separate review | Product certification | KRW 130,000 | 5 days |
| Class II with separate technical review | Technical review plus certification | KRW 691,000 | 60 days |
| Approval route with no technical review | Product approval | KRW 158,000 | 10 days |
| Approval route with technical review | Product approval | KRW 719,000 | 65 days |
| Approval route with clinical-data review | Product approval | KRW 1,495,000 | 80 days |
| Confirmed new-development device | Integrated approval and review | KRW 98,430,000 | 80 days |
These are route references for one filing, not package prices for bringing a device to market.
They also do not mean every Class I device is free of testing or quality-system obligations, or that every Class II device is eligible for the simplest certification route.
The fee table should be treated as the auditable statutory layer within a larger evidence-based project budget.
Class II is where a simple grade-to-fee lookup is most likely to mislead a project team.
A product within the delegated certification scope and requiring no separate technical review may use the five-day certification reference.
When separate technical-document review is required, the model combines the certification fee with the separate technical-review fee and combines the stated fifty-five-day review with the five-day certification step.
That produces KRW 691,000 and sixty days for electronic filing, or KRW 769,000 and sixty days for in-person or postal filing.
When clinical data are required, or another approval exception applies, the Class II device moves to the approval branch rather than remaining a routine certification.
The clinical-review approval reference is KRW 1,495,000 electronically or KRW 1,662,000 on paper, with an eighty-day stated processing period.
The interface includes an explicit confirmation switch for a Class I or Class II approval exception.
Examples may include a device outside the delegated certification categories, a product that is not essentially equivalent to an already cleared product, or a device requiring clinical evidence.
The switch does not test those legal conditions and must be used only after the route has been confirmed.
If the exception is selected, the evidence-review choice determines whether the model uses the ten-day, sixty-five-day, or eighty-day ordinary approval branch.
Article 8 uses a specific legal concept for a new-development medical device.
It concerns a device that is entirely new, compared with products already approved, certified, or notified, in one or more legally relevant characteristics such as the operating principle, the type or amount of a body-contacting raw material, the procedure or site of use, performance, or intended use.
A new brand, a new distributor, or a routine model update does not by itself establish that status.
When the user confirms the status, the calculator gives that route priority and applies the Annex 10 integrated approval-and-review reference of KRW 98,430,000.
The same amount is shown for electronic and paper channels in the current table, and the model uses an eighty-day official processing period.
Clinical, testing, quality-system, consulting, translation, and internal costs remain separate because the statutory amount does not define the full development programme.
A team considering this route should obtain a written determination of scope and should not use the calculator switch as evidence that Article 8 applies.
Annex 10 distinguishes electronic filing from in-person or postal filing for many ordinary applications.
The calculator uses the channel selected by the user and adds a new manufacturing or importing business-licence fee only when the relevant switch is enabled.
A confirmed fee reduction is capped at the gross statutory amount so the result can never become negative.
No reduction percentage or eligibility category is inferred because the applicant must establish the applicable legal condition and supporting evidence.
Payment-processor, bank-transfer, card, and service-provider charges are not treated as statutory filing fees because they may vary by payment channel and institution.
| Application item | Electronic | In person or postal | Stated period |
|---|---|---|---|
| Manufacturing or importing business licence | KRW 144,000 | KRW 160,000 | 25 days |
| Class I notification | KRW 85,000 | KRW 96,000 | 5 days |
| Class II certification | KRW 130,000 | KRW 145,000 | 5 days |
| Class II certification plus technical review | KRW 691,000 | KRW 769,000 | 60 days |
| Approval without technical review | KRW 158,000 | KRW 176,000 | 10 days |
| Approval with technical review | KRW 719,000 | KRW 799,000 | 65 days |
| Approval with clinical-data review | KRW 1,495,000 | KRW 1,662,000 | 80 days |
| New-development integrated approval and review | KRW 98,430,000 | KRW 98,430,000 | 80 days |
The calculator deliberately leaves quote-based inputs at zero.
Supplying an invented market average would create false precision and could be particularly misleading for a device with unusual standards, overseas manufacturing sites, expensive samples, or clinical evidence.
A zero input is therefore a prompt to gather evidence, not an assertion that the item is free.
A laboratory proposal may already include sample logistics, a consultant proposal may include translation, or a GMP proposal may include travel.
Rebuild each proposal into the calculator categories before comparing vendors, and record whether value-added tax is included.
The best estimate is not the one with the most entries; it is the one where every payable item appears exactly once and has a traceable source.
The product application fee and any new business-licence fee are added, then the confirmed reduction is subtracted up to the gross statutory amount.
The net statutory fee is added to testing, clinical evidence, GMP, consulting, translation, and other direct costs.
A confirmed grant is subtracted from external direct cost, with the result floored at zero. A pending application is not a confirmed grant.
Internal hours are multiplied by the documented hourly employer cost or opportunity-cost rate.
Estimated total days are divided by thirty and multiplied by the monthly contribution or opportunity cost lost through delay.
Net cash outlay, internal labour cost, and delay cost are combined to support launch-priority and funding decisions.
Total economic cost including delay is divided by contribution per unit and rounded up to a whole unit.
When contribution per unit is zero, recovery units are shown as unavailable rather than as zero units.
Contribution per unit should be selling price less the variable manufacturing, acquisition, fulfilment, payment, channel, return, and other costs that rise with each unit.
Using revenue per unit would understate the number of sales required to recover the project.
Likewise, monthly delay loss should represent contribution or another defensible economic loss rather than headline monthly revenue.
An official processing period begins from an administratively valid filing and is not the same as the complete product-development calendar.
Technical-file preparation, testing, clinical or performance evidence, GMP work, translation, supplier coordination, and other prerequisites can begin months before filing.
Deficiency-response time, review holds, repeat testing, and internal approval gates can also extend the calendar after submission.
The calculator separates these phases so a team cannot silently treat a five-day certification reference as a five-day route to commercial launch.
Enter a duration for each real workstream.
Parallel mode takes the longest workstream, while sequential mode adds all workstreams.
Choose based on dependencies and available people, not on the most attractive result.
The product route supplies its stated processing period.
If a new business licence is needed, the model uses the longer of the product period and twenty-five days rather than adding both.
Add a planning allowance based on dossier maturity, prior reviews, supplier responsiveness, and test risk.
The model does not invent a number of deficiency rounds or predict agency behaviour.
Suppose technical-file work takes thirty days, laboratory testing takes sixty days, GMP work takes forty-five days, and another prerequisite takes ten days.
If they can genuinely run in parallel, preparation is sixty days rather than one hundred forty-five days.
A Class II certification adds five official days, and a fifteen-day deficiency buffer produces an eighty-day estimate.
If those tasks actually depend on one another, sequential mode produces one hundred forty-five preparation days before the official and buffer phases.
Consider a confirmed Class III device requiring technical-document review and electronic filing.
The statutory product fee is KRW 719,000 and the stated product processing period is sixty-five days.
Assume a KRW 2,000,000 laboratory quote, KRW 1,000,000 GMP quote, KRW 500,000 regulatory consulting proposal, KRW 100,000 translation cost, and KRW 200,000 of other direct cost.
Forty internal hours at KRW 50,000 per hour add KRW 2,000,000 of internal labour.
A confirmed KRW 1,000,000 grant reduces cash outlay, while a one-hundred-forty-day total schedule and KRW 3,000,000 monthly delay loss create KRW 14,000,000 of delay cost.
| Measure | Example result | Interpretation |
|---|---|---|
| Net statutory fee | KRW 719,000 | Electronic technical-review approval fee |
| External direct cost | KRW 4,519,000 | Statutory fee plus all external quotes |
| Net cash outlay | KRW 3,519,000 | External cost less the confirmed grant |
| Internal labour | KRW 2,000,000 | Forty hours times the internal hourly cost |
| Delay cost | KRW 14,000,000 | One hundred forty days at the monthly loss assumption |
| Total economic cost | KRW 19,519,000 | Cash, internal labour, and delay combined |
| Recovery units | 196 units | Rounded up at KRW 100,000 contribution per unit |
This example is a calculation vector, not a market quote.
Its purpose is to show that the KRW 719,000 statutory fee is only one component and that schedule assumptions can dominate the economic decision.
Replace every quote and duration with evidence for the actual product before relying on the result.
Enable the new manufacturing-licence item, include facility and quality-system preparation in the GMP inputs, and count internal staff who will establish controlled procedures rather than only the external reviewer. Compare a launch plan where the first product and business licence are filed together with a contingency for facility readiness.
Separate Korean translation, manufacturer document retrieval, local label work, sample logistics, and possible overseas GMP travel. Do not assume that an approval in another jurisdiction automatically establishes the Korean category, equivalence, or evidence route.
Run each product independently under ordinary certification, separate technical review, and clinical-review approval where uncertainty remains. The resulting cost-and-time range can support sequencing decisions while the formal classification work is completed.
Treat the technical or clinical evidence plan as a critical path rather than using only the official processing period. A large monthly delay loss may justify earlier testing, parallel document work, or additional internal resources if those actions have a defensible effect on the schedule.
Model the integrated statutory fee only after the legal status has been explored, then retain an ordinary-route scenario to show decision sensitivity. The very large fee difference makes documented classification and pre-submission strategy especially important.
Normalize each quote into statutory charges, testing, clinical evidence, GMP, consulting, translation, other direct cost, and internal work. A lower headline proposal may exclude deficiency support, travel, samples, tax, or technical-file work included by another bidder.
Use net cash outlay for the financing requirement, but also present total economic cost when deciding whether the project creates value. Confirmed grants may reduce cash use without eliminating internal opportunity cost or launch-delay loss.
When two devices need similar cash, compare monthly delay loss and contribution per unit. The product with higher recoverable contribution may justify faster evidence generation, while a weak unit contribution may reveal that regulatory cost is not the central commercial problem.
A useful model should allow another reviewer to reproduce the inputs.
Store the classification memo, current statutory source, laboratory scope, consultant proposal, GMP quote, internal hourly-cost policy, task owner, and expected completion date beside the calculator output.
Mark each number as statutory, quoted, internally estimated, confirmed funding, or scenario-only.
This simple provenance system prevents a speculative number from becoming an approved commitment merely because it appears in a spreadsheet.
No. A lower-risk notification route does not automatically remove safety and performance evidence, manufacturing and quality controls, labelling duties, or post-market obligations. Confirm the applicable scope and enter the real quote and preparation time.
No. Separate technical review can create a sixty-day planning route, while clinical evidence, non-equivalence, or another exception can move the product to approval. Confirm the delegated certification category and evidence requirements first.
The Act permits the business-licence application to be submitted with at least one product application. The calculator therefore models the official periods as parallel and uses the longer one, while the real project plan must still address facility and submission readiness.
The amount can vary with the review body, product group, manufacturing-site location, audit scope, travel, and readiness work. The zero default avoids presenting an unsupported market average as an official amount.
No. Article 8 status depends on legally relevant novelty compared with products already approved, certified, or notified. Obtain an official or professionally supported determination before selecting the switch.
No. Confirm the exact legal condition, application item, evidence, and amount with the competent body. The calculator accepts a confirmed currency amount and caps it at the gross statutory fee.
No. Eighty days is a stated processing reference for the selected filing. Preparation, deficiency response, review holds, repeat testing, manufacturing readiness, distribution setup, and holidays can make the calendar longer.
Usually not. Use contribution genuinely lost, or another documented opportunity cost, after variable costs and realistic sales timing. Revenue would normally overstate the recoverable economic loss.
Start with the net selling price and subtract manufacturing or acquisition cost, fulfilment, channel and payment fees, expected return or defect loss, and other variable costs. Fixed overhead should not be deducted twice if it is already represented elsewhere.
The statutory route and fee are modelled for one product application. Run each product separately and establish a documented allocation method for genuinely shared testing, consulting, quality-system, or internal costs.
No. Card, transfer, payment-processor, tax, or service-provider charges may vary and should be added to another direct-cost field when they are payable and not already included in a quote.
No. Approval does not create demand, reimbursement, distribution, clinical adoption, or margin by itself. Recovery units are a planning threshold based solely on the contribution input and the modelled economic cost.
The calculator uses the Medical Devices Act identified by law ID 009514 and MST 281933, and the Enforcement Rule identified by law ID 009740 and MST 287877.
The detailed approval regulation is MFDS Notice 2026-34, administrative-rule serial 2100000278374, effective April 28, 2026.
The quality-management standard is MFDS Notice 2026-46, administrative-rule serial 2100000281580, effective July 1, 2026.
Fee and processing-period anchors were checked on August 9, 2026 against rules effective July 1, 2026.
Because Korean law, forms, delegated categories, and agency guidance can change, confirm the current text and filing instructions on the application date.
Start with a range while classification is open, then update the model when the route, laboratory scope, GMP plan, vendor quotes, internal schedule, and funding are confirmed.
Preserve the date and source of every material input, and obtain regulatory, legal, accounting, and commercial review before committing capital or promising a launch date.