Class 1 Medical Device Notification in Korea: The Complete Seller's Guide

Key takeaway — A Class 1 medical device is registered by "notification" through the MFDS electronic filing portal, with no technical file review. The statutory fee is KRW 85,000 on an e-filing basis, the statutory processing period is 5 days, and the practical lead time including document preparation typically runs 2–4 weeks. The real question is who files. Product notifications belong to manufacturers and importers — so a reseller sourcing domestically should check whether a sales business notification is needed instead, and a direct-importing seller must secure an import business license before notifying. Part 1 of this series dealt with the boundary question — "is my product a medical device?" This Part 2 covers the next step: actually executing the notification.

Who files the notification — the three positions a seller can be in

The Medical Devices Act assigns product notification to "a manufacturer, for the medical device it intends to manufacture" (Article 6(2)) and to "an importer, for the medical device it intends to import" (Article 15(2)). In other words, the obligation attaches to the business, not to the product. If you sell online, start by locating your own position.

Your position	Product notification duty	What to secure first
Domestic sourcing / consignment sales	None — you sell products the manufacturer or importer has already notified	Check whether a sales business notification is required
Direct import and sale	Yes — you are the party filing the import notification	Import business license → product import notification
Own-brand manufacturing	Yes — you are the party filing the manufacturing notification	Manufacturing business license → product manufacturing notification

If you are a reseller who has been agonizing over "do I need to notify first," what you actually need to check is your supplier's notification or certification number and your own sales business notification. Conversely, if you import directly or manufacture under your own brand, the procedure below is your job as written. Note that structures outsourcing manufacturing processes or quality-control testing (OEM arrangements and the like) are also permitted as prescribed by Ordinance of the Prime Minister; in that case a copy of the outsourcing contract becomes an attachment (Article 5(1)3 of the Enforcement Rule).

How the e-filed notification proceeds, step by step

A Class 1 notification is the only procedure among the four classes with no technical file review. It is, however, a notification that requires acceptance — submission alone does not complete it; the filing is reviewed and accepted if found conformant (Article 6(10) of the Act). On an e-filing basis, the flow runs as follows.

Step	What you do	Typical duration
1. Confirm product classification and class	Fix the item name and class — classification criteria are in Annexed Table 1 of the Enforcement Rule	A few days, depending on your documentation
2. Business license first	Import or manufacturing business license (skip if already held)	License decision within 25 days, plus preparation time
3. Set up the e-filing portal	Register on the medical device electronic filing portal and enroll a digital certificate	Within a day
4. Draft and submit the notification	Annexed Form No. 7 — product name, item name, model name, intended use, and so on	A few days once documents are ready
5. Pay the fee	KRW 85,000 on an e-filing basis	Immediate
6. Review and acceptance	Statutory processing period of 5 days; a notification certificate is issued on acceptance	Around 5 days

Manufacturing notification documents are submitted to the National Institute of Medical Device Safety Information (NIDS), the body entrusted with notification processing (Article 7(1) of the Enforcement Rule), and import notifications follow the same structure (Article 15(6) of the Act). The entire process can be handled by e-filing — no visits required.

Here the 2–4-week practical lead time reveals itself. Processing the notification takes 5 days, but the work in front of it — fixing the product classification, meeting the business requirements, and extracting documents from the manufacturer — consumes most of the time. Get step 1 wrong in particular — you assumed Class 1, but a measuring function or sterile supply makes it Class 2 — and you are no longer filing a notification but starting a certification procedure from scratch. It is safer to first check the full picture of procedures, timelines, and costs by class in the class-by-class procedure overview.

What to prepare — the documents

The statutory attachments for a Class 1 notification are minimal. But there is a separate practical kit for filling in the notification form and meeting the distribution requirements that follow.

Category	Documents	Notes
Statutory attachment	Copy of the outsourcing contract (where manufacturing processes or quality testing are outsourced)	Article 7(1) of the Enforcement Rule — not applicable without outsourcing
For the form	Product specifications; structure and raw materials; intended-use documentation	The intended-use entry is the basis for the item and class determination
For imports	Manufacturer verification documents; contractual documents	The manufacturer's responsiveness is the main lead-time variable
For distribution	Draft Korean labeling	Not a notification document, but a frequent snag at customs clearance and in distribution

The drafting instructions, requirements, and scope of exemptions for attachments are set by MFDS notice (Article 7(3) of the Enforcement Rule), so the required level can vary by product. The order of preparation and the points where filings most often get rejected are covered separately in the Class 1 medical device registration guide.

Costs and timelines — what to budget

Item	Amount / period	Notes
Product notification fee	KRW 85,000	Annexed Table 10 of the Enforcement Rule, e-filing basis
Import / manufacturing business license fee	KRW 144,000 each	Where a business license must come first
Sales business notification fee	KRW 10,000	The item for resellers to check
Statutory processing period	Notification: 5 days · business license decision notified within 25 days	The 25-day limit is Article 6(8) of the Act
Practical lead time	Typically 2–4 weeks	Includes document preparation and business licensing; longer if manufacturer documents lag

That is everything the government charges. If you engage an agency, the service fee is separate — and whether a quote itemizes the statutory fees and the service fee separately is the first test when comparing agencies. Common questions about fees and timelines across the registration process are addressed on our regulatory consulting services page.

Is acceptance the end of it?

Three things remain.

First, labeling. The container and outer packaging must carry the statutory particulars — notification number, manufacturer, and so on — in Korean. Bringing the goods in first and then getting caught on the label is the classic Class 1 bottleneck.

Second, advertising scope. A notification does not license any claim you like: performance and efficacy may be claimed only within the notified intended use. Step outside it, and the misleading-advertising issues covered in Part 1 of this series come right back to life even after registration.

Third, the sales business notification. Separately from product registration, anyone intending to sell medical devices is in principle subject to a sales business notification (Article 17 of the Act, with some exemptions). How to handle it for online selling will be covered in a later part of this series.

One more thing — a good share of Class 1 products are excluded from KGMP conformity assessment, but some, such as sterile products, are exceptions. Whether yours is an exception is something to confirm before you notify.

What CLARE Partners does

CLARE Partners handles each stage of this procedure as separately itemized services.

• Class 1 notification service — from document preparation to filing, service fee from ₩2.0M (the statutory fee of KRW 85,000 is itemized separately)
• Import / manufacturing business license service — application documents and filing, including review of facility and quality-manager requirements, service fee from ₩2.0M
• Sales (rental) business notification service — document preparation and filing, service fee from ₩0.5M
• Free pre-review — send us your product details and we give a first response on the class, the required procedures, and your document readiness within 1 business day

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

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What eats time in a Class 1 notification is not the notification itself but the product classification and document gathering in front of it. Send your product details for a free pre-review before you sign a sourcing contract, and we will start by confirming whether your product really is Class 1, whether a business license is needed, and how long the overall schedule will take.

Legal basis: Medical Devices Act (Act No. 21263, in force 1 Jul 2026) Article 6 (Manufacturing Business Licenses) · Article 15 (Import Business Licenses) · Article 17 (Notification of Sales Business); Enforcement Rule of the Medical Devices Act (Ordinance of the Prime Minister No. 2127, in force 1 Jul 2026) Article 7 (Manufacturing Notification Procedure) · Article 65 (Fees) and Annexed Table 10 — based on the original texts in the National Law Information Center; fees, processing periods, and other particulars may change when the statutes are amended.