Importing Class 1 Devices from Overseas — Start with the Import Business License

Key takeaway — To import and sell a foreign Class 1 medical device in Korea, two procedures are required: the company-level import business license (Medical Devices Act, Article 15(1); statutory fee KRW 144,000) and the per-product Class 1 import notification (fee KRW 85,000; typically 2–4 weeks). Because the license application must be filed together with at least one product notification, approval, or certification (Article 15(3)), a first import always moves as one set — the business license plus the first product notification. Add manufacturing-source labeling consistency and customs-requirement checks, and that is the preparation that must be finished before the first shipment.

Import business license and import notification — which comes first?

The previous installment in this series covered why using medical-device claims on a product sold in Korea means entering the registration track. This installment is the next step — the case where you want to import directly a Class 1 medical device made overseas.

Here the procedure splits into two layers, and Article 15 of the Medical Devices Act sets that structure.

(1) A person who intends to import medical devices as a business shall obtain an import business license from the Minister of Food and Drug Safety. (…) (3) A person applying for an import business license under paragraph (1) shall, at the same time, apply for at least one import approval or import certification under the subparagraphs of paragraph (2), or file at least one import notification. — Medical Devices Act, Article 15

The first layer is the company's standing. Unlike the sales business, which is a notification, the import business is a license. You must meet the requirements and obtain the license from the regional Office of Food and Drug Safety with jurisdiction — and this is where the quality manager and the facility requirements enter the picture.

The second layer is per product. Even after you become a licensed importer, each product needs an import approval, certification, or notification according to its class (Article 15(2)). For Class 1, that is a notification with no review. Low-risk devices designated by MFDS public notice can also be filed grouped by product group (subparagraph 1 of the same paragraph).

And paragraph (3) fixes the practical order — the import business license must be applied for together with at least one product filing. It is not “get the license first, add products later”: the application is not even accepted unless the first product's notification documents come with it. That is why this article is titled “start with the import business license” — and why the license has to run in parallel with preparing your first product.

What the import business license requires

Requirement	What it involves	Basis
Application and filing office	Submit the application (attached Form No. 1) with supporting documents to the regional Office of Food and Drug Safety with jurisdiction over the place of business	Enforcement Rule, Article 29(1)
Simultaneous product filing	At least one product import approval or certification application, or one import notification, filed together	Act, Article 15(3)
Quality manager	Appoint a quality manager who meets the qualification requirements; training within 6 months of starting work, then at least 8 hours per year	Act, Article 6-2 (applied mutatis mutandis under Article 15(6)) · Enforcement Rule, Article 13
Facilities and quality system	Quality-testing facilities and a manufacturing and quality management system (Enforcement Rule, attached Table 4). The test room can be omitted if testing is entrusted to a testing and inspection laboratory	Act, Article 15(4) · Enforcement Rule, Article 31
Statutory fee	KRW 144,000 (e-filing basis)	Enforcement Rule, attached Table 10

The item small importers hit first is the quality manager. You must appoint personnel who meet the qualification requirements for education and experience. In some cases a qualified CEO can double in the role, but the quality manager position carries its own restrictions on concurrent duties, so check this at the initial staffing stage.

The facilities bar is lower than people expect. If quality-control testing is entrusted to a medical device testing and inspection laboratory, you can proceed without your own test room (Enforcement Rule, Article 31(2)). What remains is the business premises, storage conditions matched to the products you handle, and the quality documents that govern the import and release process.

As the fee table shows, the amount paid to the government is KRW 144,000. If you outsource the work, check that the quote separates the statutory fee from the service fee — a lump-sum quote makes scope comparison impossible. The full picture of procedures, timelines, and costs by class is in the class-by-class procedure overview.

How the Class 1 import notification proceeds

Step 1 — Confirm the product classification and class. Establish which product name the device falls under and which class it belongs to. Foreign and Korean classifications can diverge: a device that is Class I in its home market can be Class 2 under the Korean criteria. If the class changes here, every schedule and cost that follows changes with it — this is the first button on the shirt.

Step 2 — Run it in parallel with the license preparation. While putting the quality manager and facilities in place, prepare the first product's notification documents at the same time. Because of the simultaneous-application structure of paragraph (3), these two are parallel tracks, not sequential ones.

Step 3 — File the notification. The Class 1 import notification is filed with the National Institute of Medical Device Safety Information (NIDS) on the prescribed form (attached Form No. 7) (Enforcement Rule, Article 30(3)). It proceeds by e-filing, and the decisive difference from Class 2 and above is that there is no technical file review.

Step 4 — After acceptance, prepare for distribution. Once the notification is accepted, you move on to Korean labeling, UDI registration, and customs-requirement checks. That stage continues below.

Item	Detail
Procedure	Product (or product-group) import notification — no technical file review
Filing office	National Institute of Medical Device Safety Information (e-filing)
Statutory fee	KRW 85,000 (e-filing basis)
Statutory processing period	5 days
Practical lead time	Typically 2–4 weeks including document preparation

The notification procedure itself, and the points where filings most often bounce, are covered separately in the Class 1 medical device notification guide.

Why manufacturing-source evidence has to be secured from day one

What most distinguishes importing from domestic manufacturing is that the owner of the documents is overseas. At the center of that sits the “manufacturing source.”

The Enforcement Rule treats cases where the country of manufacture, the manufacturer, and the manufacturing site are all the same as “the same manufacturing source” (Article 30(1)). The manufacturing source, in other words, is a bundle of three data points.

• Country of manufacture — in which country it is made
• Manufacturer — under whose responsibility it is made
• Manufacturing site — at which physical facility it is made

In a contract-manufacturing structure, the manufacturer and the manufacturing site can differ — the brand owner in country A, the factory in country B. Write the notification without pinning this down and you get the classic accident: the manufacturing-source entries on the notification, the label, and the invoice disagree with one another. Inconsistent entries are grounds for a deficiency request — and for a customs hold.

In practice, secure three things before the first import.

First, manufacturing-source verification documents. Fix the exact names and addresses of the manufacturer and the manufacturing site through official documents issued at the source — quality system certificates, manufacturing-source attestations, and the like. It is common for the company name in an email to differ from the legal entity name on the documents.

Second, a document-supply clause in the contract. Write into the supply agreement an obligation to provide the documents and cooperation needed for registration and labeling. Class 1 keeps the paperwork light at the notification stage, but every later event — a specification change, an added model — calls for the manufacturer's documents again. For reference, on the approval and certification tracks, documents proving the manufacturing site's manufacturing and quality management system are a submission requirement (Enforcement Rule, Article 30(1)), and the same article allows some documents to be omitted if you prove the product is identical, from the same manufacturing source, to a device already approved — which is to say, manufacturing-source evidence only gets heavier as the class goes up.

Third, a one-page labeling standard. Put the confirmed renderings of the three manufacturing-source elements, the product name, and the model name on a single page, and make the notification, the labels, the invoices, and the customs documents all follow that page. Remember, too, that if the manufacturing-source information later changes, a change procedure follows.

How this connects to customs clearance

An accepted notification does not mean the goods walk straight in. Medical devices are subject to requirement verification at customs, so in practice imports go through the standard advance report for customs clearance filed through the Korea Medical Devices Industry Association. The notification (or approval) data is checked there against the actual import shipment data — so the “one-page labeling standard” from the previous section becomes, unchanged, your safety device at customs.

Three preparations must be finished together before the first shipment.

1. Korean labeling — Korean labeling on containers and packaging is an obligation that attaches before distribution. Having it applied at the manufacturing source is the textbook route; if that is not feasible, plan a bonded-area labeling operation in advance.
2. UDI standard code — Before release, the standard code must be displayed and registered in the Integrated Medical Device Information System.
3. Back-calculate the shipping schedule — Work backwards from the completion dates of the business license, the product notification, and the final label to place orders and book shipment. “Goods first, paperwork while the ship sails” comes back as a storage-fee invoice.

Common reasons for customs holds, and the details of Korean labeling, UDI, and supply reporting, are laid out in the medical device import guide — customs edition; quick definitions of the terms that come up along the way are collected in the glossary.

What CLARE Partners does

CLARE Partners handles every segment of this article as separately itemized services.

• Import business license service — application preparation and filing, including review of the facility and quality-manager requirements, from ₩2.0M (the statutory fee of KRW 144,000 itemized separately)
• Class 1 notification service — from preparing the submission documents to filing the notification, from ₩2.0M (the statutory fee of KRW 85,000 itemized separately)
• UDI standard code registration — code generation and registration in the Integrated Medical Device Information System, from ₩0.5M
• Free pre-review — send us your product details and manufacturing-source documents, and we reply within 1 business day with a first read on the class, the required procedures, and the state of your documents

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

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What separates cheap first imports from expensive ones is not the difficulty of the paperwork but the order. Confirm the product classification, run the license and the notification in parallel, and finish the label and customs preparation before you place the order — and a Class 1 import becomes a predictable 2–4 week procedure. Send your product details and manufacturing-source documents for a free pre-review through the regulatory consulting services page, and we will frame the first picture for you, from class confirmation to a back-calculated shipping schedule.

Legal basis: Medical Devices Act (Act No. 21263, in force 1 July 2026) — Article 15 (Import Business License, etc.) · Article 6-2 (Quality Manager) (applied mutatis mutandis to importers under Article 15(6)) · Enforcement Rule of the Medical Devices Act — Article 29 (Application for an Import Business License, etc.) · Article 30 (Application for Import Approval, etc.) · Article 31 (Standards for Quality-Testing Facilities and Manufacturing and Quality Management Systems) — based on the original texts in the National Law Information Center; the content may change as the statutes are amended. Fees are on an e-filing basis under attached Table 10 of the Enforcement Rule (amended 1 July 2026).