Class 2 Medical Device Certification in Korea, End to End — A Seller's Perspective

Key takeaway — A Class 2 medical device is subject to certification, not notification. You prepare a technical file, have it reviewed by a technical file review body designated by the MFDS (Ministry of Food and Drug Safety), and receive certification once it passes. The statutory government fee is KRW 130,000 on an e-filing basis, but the technical file review fee and the KGMP audit fee are separate out-of-pocket costs paid directly to the review bodies. The practical lead time, including document preparation, is typically 3–4 months, and agency fees start from ₩6.0M. The single biggest difference from the Class 1 notification guide is the existence of a review — this article follows the three stages of technical file drafting, review, and certification from a seller's perspective.

Notification vs. certification — where Class 2 sits

Medical devices are classified into classes according to their intended use and the potential risk they pose to the human body (Article 3 of the Medical Devices Act), and manufacturers and importers must obtain a manufacturing or import approval or certification, or file a notification, according to that classification (Articles 6(2) and 15(2)). Class 2, as a rule, follows the certification track.

Class	Procedure	Statutory fee (e-filing)	Practical lead time
Class 1	Notification — no technical file review	KRW 85,000	Typically 2–4 weeks
Class 2	Technical file review + certification	KRW 130,000	Typically 3–4 months
Class 3·4	Technical file review (may include clinical data) + approval	From KRW 719,000	Typically 6–8 months for Class 3

The decisive difference from Class 1 is that a review now exists. That is why two institutions enter the picture: the technical file review body that examines the file's conformity (designated by the Minister of Food and Drug Safety — Article 6-4), and the Korea Institute of Medical Device Safety Information (NIDS), which handles certification and notification affairs under the delegation provision (Article 44(2)). The full picture of procedures, timelines, and costs by class is laid out in the procedure overview guide.

The holder also needs re-confirming. The holder of a product certification is the manufacturer or importer. If you are a seller sourcing products already certified in Korea, what you check is your supplier's certification number and your own sales business notification; if you plan to import directly and sell, you start with an import business license and the entire process below becomes your own work. The three seller positions are covered in detail in the Class 1 notification guide.

How certification proceeds — drafting, review, certification

The broad flow is three stages — technical file drafting → review by the review body → certification. Unpacked into working order, it looks like this.

Stage	What you do	Notes
① Confirm product classification and class	Fix the product name and class — see how to check product classification	Get this wrong and the entire procedure changes
② Business license first	Manufacturing or import business license (skip if already held)	Statutory fee KRW 144,000 each
③ Testing	Design the test items, commission a testing laboratory, obtain reports	Test reports are the backbone of the technical file
④ Technical file drafting	Draft with intended use, structure, performance, and test data kept consistent	Most deficiency letters originate here
⑤ Review by the review body	Review by the technical file review body; respond to deficiency requests	The number of deficiency rounds is the biggest timeline variable
⑥ Certification	Certification after a conformity decision — fee KRW 130,000 on an e-filing basis	Certificate issued

One parallel track sits alongside. Because an applicant for certification must submit manufacturing and quality management system documentation and other required materials (Article 6(5)), KGMP (Korean Good Manufacturing Practice) conformity assessment is also required, depending on the product and business type. The KGMP audit is conducted not by the MFDS but by separate review bodies (KTL, KTR, and others); preparation is covered separately in the KGMP guide.

One caveat — some products, such as novel product types requiring clinical data, may follow a different procedure and timeline from the table above. It is safest to confirm at the classification stage that your product is on the standard Class 2 certification route.

What goes into the technical file

The Act requires an applicant for certification to submit "manufacturing and quality management system documentation, a technical file, clinical trial data, and other required materials" as prescribed by Ordinance of the Prime Minister (Article 6(5)). In practice, the typical composition is as follows.

Section	Contents	Notes
Product overview	Intended use, principle of operation, model composition	The intended use statement anchors the class and the permissible scope of advertising
Structure and raw materials	Structural diagrams; specifications of raw materials and components	For imports, obtaining source documents from the manufacturer is the crux
Performance and safety	Performance specifications; electrical and mechanical safety and other test data	Alignment between test reports and what the file states is the core
Comparison data	Comparison with previously approved or certified products (depending on the product)	Evidence of equivalence

Harder than the document list itself is consistency. When intended use, test specifications, reports, and labeling contradict one another, deficiency rounds repeat — and when they repeat, 3–4 months stretches beyond that. Drafting guidance continues in the practical guide to writing the technical file and the Class 2 medical device certification guide.

Where the money goes — statutory fees vs. review-body costs

The most common misunderstanding about Class 2 costs is "KRW 130,000 for the certification and you're done." Split by payee, there are three blocks.

Payee	Item	Amount
Government — statutory fee	Class 2 manufacturing or import certification	KRW 130,000 (Annex 10 of the Enforcement Rule, e-filing basis)
Government — statutory fee	Manufacturing or import business license (if needed)	KRW 144,000 each
Review body — at cost	Technical file review fee	Published rates of the review body (KTL, KTR, etc.)
Review body — at cost	KGMP audit fee	Published rates of the review body
Testing laboratory — at cost	Testing fees	Varies by product and test items
Agency — optional	Regulatory affairs service fee	From ₩6.0M is the typical starting line

Statutory fees are published in legislation, but review-body fees and testing costs are out-of-pocket charges at each body's published rates and vary by product. That is why whether a quotation itemizes statutory fees, review-body costs, and agency fees separately is the first benchmark for comparing agencies. Frequently asked cost questions and the itemized service fee structure are laid out on the regulatory consulting services page.

Where the 3–4 months go — and what remains after certification

Most of the typical 3–4 months is spent not waiting on review but on the front end. Testing takes weeks or more depending on the items, the technical file cannot be completed until test results are in, and responding to deficiency requests during review follows. Put the other way around — the way to shorten the timeline is not to hurry the review, but to nail down the test item design and document consistency before submission so that deficiency rounds drop.

Three things remain after the certificate arrives. First, the labeling on containers and outer packaging must meet the statutory requirements. Second, labeling and advertising are permitted only within the certified intended use, and medical device advertising is subject to prior review — step beyond that scope and the misleading advertising issues covered in part 1 of this series come right back to life. Third, separately from product certification, check whether the selling entity needs a sales business notification. Labeling and advertising rules each get their own later installment in this series.

What CLARE Partners does

CLARE Partners handles each stage of Class 2 certification as an itemized service.

• Class 2 certification service — the full certification process, from technical file drafting support and MFDS filing to deficiency response (one round included), from ₩6.0M (the KRW 130,000 statutory fee and review-body costs itemized separately)
• Testing commissioning and management — test item design, quotation comparison and commissioning across testing laboratories, report management, from ₩2.0M (testing fees billed separately at laboratory rates)
• KGMP support — manufacturing KGMP from ₩8.0M; import GMP document review from ₩6.0M (review-body fees separate)
• Import and manufacturing business license service — document preparation and filing, plus review of facility and quality manager requirements, from ₩2.0M
• Free pre-review — send us your product information and we return a first assessment of the class, required procedures, and document readiness within one business day

The full itemized fee schedule and quotation structure are available on the regulatory consulting services page.

---

What drives cost and timeline at Class 2 is not the certification filing itself, but test item design and the consistency of the technical file. Before you sign a sourcing contract or commission testing, send us your product information for a free pre-review — we will first confirm whether your product is on the standard Class 2 certification route, which tests and documents it needs, and the overall schedule and cost structure.

Legal basis: Medical Devices Act (Act No. 21263, in force 1 Jul 2026) Article 3 (Classification and Designation) · Article 6 (Manufacturing Business License, etc.) · Article 6-4 (Designation of Technical File Review Bodies, etc.) · Article 15 (Import Business License, etc.) · Article 44 (Delegation and Entrustment of Authority), and Enforcement Rule of the Medical Devices Act Article 65 (Fees) and [Annex 10] — based on the original texts in the National Law Information Center; fees and procedures may change when legislation is amended. Review-body and testing-laboratory fees are separate out-of-pocket costs at each body's published rates.