Class 2 Certification Costs: Why Every Quote Is Different — How Testing and Review Fees Break Down

Key takeaway — Class 2 certification costs split four ways. ① The government statutory fee of KRW 130,000 (electronic filing) — the same fixed amount no matter who files for you. ② Review body fees for technical file review and the KGMP audit — set by each body's published rates. ③ Testing costs — the biggest variable, driven by the product and its test items. ④ The consulting fee — from ₩6.0M. When totals differ from quote to quote, the difference almost always sits in the design and scope of ③ and ④. So compare strand by strand, not by total — and a quote that will not break itself apart cannot be compared at all. This is exactly where the cost structure parts ways with a review-free Class 1 notification (KRW 85,000).

Why do quotes for the same product differ by a factor of two?

Collect Class 2 certification quotes from several firms and the totals spread widely. Does that mean the gap in competence is just as wide? Check something else first — four kinds of money with entirely different natures are mixed inside that single "total."

Strand	Nature	Amount	Paid to
① Statutory fee	Published fixed amount	KRW 130,000 (electronic filing)	MFDS — Attached Table 10 of the Enforcement Rule
② Review body fees	Published rates	Technical file review and KGMP audit fees	Review bodies (KTL, KTR, etc.)
③ Testing costs	Varies by product	Depends on the number and design of test items	Testing laboratories
④ Consulting fee	Quoted per firm	From ₩6.0M (CLARE Partners)	Consulting firm

Class 1 is a notification with no technical file review, so it usually ends with ① and ④ alone (for exceptions such as sterile products, see the Class 1 KGMP guide); from Class 2 upward, technical file review by a certification body, testing, and KGMP appear for the first time, and ② and ③ enter the bill. The five-step flow of the whole procedure is covered in the Class 2 medical device certification guide, and the full picture of procedures, timelines, and costs by class in the procedure overview by class.

If two quotes differ by a factor of two, the difference almost always comes from ③ and ④. Let us take the strands apart one by one.

Start with the fixed amount — how much is the statutory fee?

The statutory fee paid to the government is a fixed amount published in Attached Table 10 of the Enforcement Rule of the Medical Devices Act. It is the same no matter who files for you and no matter which firm you go through.

Item	Amount (electronic filing)	Note
Class 2 manufacturing or import certification	KRW 130,000	The subject of this guide
Manufacturing or import business license	KRW 144,000 each	Where the business license must come first
Sales (rental) business notification	KRW 10,000	A check item for resellers

One piece of practical instinct follows: if the "statutory fee" line in a quote differs from this table — or there is no such line and the amount is dissolved into the total — that quote is itself a document that needs verifying. The statutory fee is not a subject for negotiation; it is the reference point you check everything else against.

Why are review body fees marked "billed separately"?

A Class 2 certification carries two kinds of review: the technical file review on the product side, and the KGMP audit on the manufacturing site side (for imports, the overseas manufacturing site). These reviews are run not by the MFDS but by separate review bodies (KTL, KTR, and others), and the fees follow the rates each body publishes.

Knowing exactly what this money is matters.

• It is not money the consulting firm receives. It is a pass-through cost paid directly to the review body. An honest quote therefore separates this item from the consulting fee and marks it "billed separately (at cost)."
• Published rates mean you can cross-check. Because each body publishes its rates, this is the one strand where you can verify that a quote's numbers have not been inflated.
• Fold it into the total and comparison collapses. Write it into the consulting fee as "review fees included," and no one can tell where the body's money ends and the firm's share begins.

Why the KGMP audit runs through a separate body, and what to prepare first, is covered separately in the KGMP guide.

Why do testing costs differ from product to product?

Of the four strands, testing costs swing the widest. They are pass-through costs paid directly to accredited testing laboratories, and the amount varies sharply with the product and the test design. The skeleton of Class 2 testing looks like this:

Test	Applies to	Standard series
Electrical and mechanical safety	Devices that use electricity	IEC 60601-1
Electromagnetic compatibility (EMC)	Devices that use electricity	IEC 60601-1-2
Biological safety	Devices with patient-contacting parts	ISO 10993
Performance testing	All products	Product-specific standards

Within the same Class 2, whether the device uses electricity, whether it touches the body, and how many models there are changes the very number of test items — and the item count is the cost. One more variable sits on top: items that can be waived. Foreign test reports the manufacturer already holds (CE and the like) can be partially accepted after a case-by-case check that the test standards and conditions match Korean requirements — and every accepted report removes a duplicated test from the bill.

In the end, differences in testing quotes are differences not in laboratory price lists but in test design. If a quote lumps testing in as "included," you must ask: on the assumption of which items, and how many? Was acceptance of the manufacturer's existing reports reviewed? And if a deficiency notice forces retesting, who bears that cost?

Consulting fee from ₩6.0M — what does it include?

The last strand is the firm's own share, the consulting fee. CLARE Partners' Class 2 certification fee starts from ₩6.0M and covers technical file drafting support, MFDS filing, review response, and deficiency response (one round included).

The word "from" deserves attention. The fee moves with product complexity, model count, and the state of the documentation, so quoting a floor before the scope is fixed is the natural notation, not a trick. That leaves two things to confirm in the consultation room:

• What raises the price, and by how much — whether the firm explains its surcharge conditions: added models, document rewrites, whether test design is in scope.
• How deficiencies are handled — how many rounds of deficiency response are included, and the per-round cost beyond that. Deficiency rounds are the main cause of schedule slips; if these terms are not in the contract, the final cost is unknowable at signing.

How should I compare the quotes?

Lay the quotes you received side by side and read them in three passes.

First, ask for the four-strand breakdown. Check whether the statutory fee, review body fees, testing costs, and consulting fee are separated. The reaction to that request is itself information about the firm.

Second, align the scope. Set the number of test items, the included deficiency rounds, and KGMP coverage to the same conditions, and the reason for the difference in totals surfaces. Cheaper at equal scope can be a rational choice; at unequal scope, the comparison never existed.

Third, filter the language that promises outcomes. Certification and approval are decided by the review body and the MFDS, so no consulting firm is structurally in a position to promise a result. The larger a "we guarantee approval" line is printed, the more carefully the deficiency and retest terms and the scope of service deserve checking.

The seven criteria for judging a firm — including the three-way quote split — and the questions you can put across the table verbatim are set out in how to choose a regulatory consultant, and the fee for every service item is published on the regulatory consulting services page.

What CLARE Partners does

A CLARE Partners Class 2 quote separates the four strands above.

• Class 2 certification service — technical file drafting support, MFDS filing, and review deficiency response (one round included), consulting fee from ₩6.0M (the KRW 130,000 statutory fee and review body fees are listed separately)
• Testing coordination — test item design, laboratory quote comparison and commissioning, and report management, from ₩2.0M (testing costs are paid to the laboratories separately)
• KGMP support — manufacturing KGMP from ₩8.0M; import GMP document audit from ₩6.0M, on-site audit from ₩9.0M (review body fees billed separately at cost)
• Free review of quotes you have received — send us another firm's quote and we will check, free of charge, whether statutory fees, pass-through costs, and the consulting fee are separated, and flag missing or over-billed items

The full fee schedule and quote structure are on the regulatory consulting services page.

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The crux of Class 2 costs is not haggling — it is test design and a fixed scope. Before collecting quotes, send us your product information and the list of documents your manufacturer holds through a free pre-review, and we will start from what matters: which tests you need, what can be waived, and how the four strands of cost frame up for your product.

Basis: Enforcement Rule of the Medical Devices Act (Ordinance of the Prime Minister No. 2127, in force 1 July 2026), Article 65 (Fees) and Attached Table 10 — per the original text at the National Law Information Center; fees may change when the legislation is amended. Review body fees and testing costs follow each body's published rates and product-specific actual costs, and this article states no definitive amounts for them.