Overseas Direct Purchase and Purchasing-Agent Sales of Medical Devices — What Is Allowed and What Is Not

Key takeaway — Bringing in a small quantity for your own personal use is possible within limits, after confirmation at customs clearance. But selling or giving away a medical device that has no Korean approval, certification, or notification — or importing, storing, or displaying one for the purpose of sale — is prohibited by Article 26(1) of the Medical Devices Act, and a violation is punishable under Article 51 by imprisonment of up to 5 years or a fine of up to KRW 50 million (the two may be imposed concurrently). The MFDS likewise advises that selling unregistered foreign medical devices while collecting buyers' personal customs clearance codes is illegal. The lawful route to selling is an import business license + item-by-item approval, certification, or notification + a sales business notification.

Buying one blood pressure monitor for yourself is fine — so why can't you sell it?

The basic structure of the Medical Devices Act is this. To import medical devices as a business you must obtain an import business license from the MFDS (Ministry of Food and Drug Safety) (Article 15(1)), and for every product you intend to import you must complete import approval, import certification, or import notification (Article 15(2) — per item in principle; per item category for low-risk devices designated by MFDS public notice). In other words, the normal route the law envisions is "a licensed importer bringing in an approved, certified, or notified item."

Overseas direct purchase for your own personal use is an exceptional channel outside this system, allowed within limits through a confirmation procedure at the customs clearance stage. It is premised throughout on personal use, and the detailed criteria are judged at the customs clearance stage item by item and case by case, so it is hard to generalize about "items you can direct-purchase." The MFDS repeatedly advises that products bought through overseas direct purchase have not gone through the Korean registration procedures, so their safety and effectiveness have not been confirmed.

The problem begins the moment this exceptional channel is used as a channel for business. The moment the goods come in not for your own use but to be sold to others, in the eyes of the law they become "unregistered medical devices imported for the purpose of sale."

What exactly does the law prohibit?

Article 26(1) of the Medical Devices Act provides:

No person shall repair, sell, rent, give away, or use a medical device for which approval or certification has not been obtained or notification has not been filed under Article 6(2) or Article 15(2), nor manufacture, import, repair, store, or display one for the purpose of sale, rental, giving away, or use. — Medical Devices Act, Article 26(1), main text

Three points need underlining.

First, the subject is "no person." This is not a provision for importers and sellers only. A private individual without a business registration selling on a secondhand marketplace is equally within its scope.

Second, it is not only selling that is prohibited. Rental, giving away (gratuitous transfer), and the import, storage, and display of devices for the purpose of sale or giving away are prohibited as well. "I haven't sold a single unit yet" is no defense. The prohibited act can already be complete at the point you bring the goods in to sell them and stack them in a warehouse or put up the listing.

Third, the penalty is the heaviest among the provisions covered in this series. A violation of Article 26(1) falls under Article 51(1)2 of the Medical Devices Act — imprisonment of up to 5 years or a fine of up to KRW 50 million — and imprisonment and fine may be imposed concurrently (Article 51(2)). That is one step above the 'misleading claims' issue covered in part 1 of this series (Article 26(7); imprisonment of up to 3 years or a fine of up to KRW 30 million under Article 52).

Does the 'purchasing-agent' format work as a shield?

The typical purchasing-agent structure looks like this. The business only takes orders and passes them to an overseas seller; the goods go through customs clearance in the consumer's name; and the business explains, "I never imported anything and never sold anything — I only ran an errand." That is why it asks consumers for the personal customs clearance code required at customs.

The MFDS guidance is unambiguous: selling foreign medical devices without Korean registration to Korean consumers while collecting buyers' personal customs clearance codes online is illegal. Over the past year the MFDS detected unregistered overseas direct-purchase sales of items such as laser hair-removal devices, blood pressure monitors, cupping devices, anti-snoring magnets, bruxism (teeth-grinding) guards, and nebulizers on online platforms, and said it continues these inspections, blocking illegal listings as they are identified (Korea Policy Briefing, March 2025).

Put the other way round: substance, not format, is the test. Bringing in a product that already holds Korean item approval, certification, or notification through the formal import system and selling it is ordinary import sales that does not even need to be called "purchasing agency" — and that is the lawful route.

What is allowed and what is not — at a glance

Situation	Verdict	Basis and conditions
Direct purchase of a small quantity of a medical device for your own use	Possible within limits	Premised on personal use; confirmation procedure at customs clearance. Detailed criteria judged per item and situation
Reselling or giving away a direct-purchased medical device	Not allowed	Article 26(1) — sale and giving away of unregistered devices prohibited; "no person"
Selling unregistered medical devices in purchasing-agent format (collecting personal customs clearance codes)	Not allowed	MFDS advises it is illegal. Import and display for the purpose of sale fall under Article 26(1)
Bringing goods in to sell — warehousing them, posting the product page	Not allowed	Article 26(1) — import, storage, and display for the purpose of sale also prohibited
Selling in Korea a product that holds only FDA or CE certification	Not allowed	Foreign certification does not replace the Korean procedure — the item-by-item procedure of Article 15(2) applies separately
Selling with an import business license + item approval, certification, or notification + a sales business notification	Allowed	The formal route under Articles 15 and 17

"But it's an FDA-approved product" — three common misconceptions

Misconception 1: "It has foreign certification, so safety is proven and I can sell it." Foreign certification and Korean registration are separate procedures. Selling in Korea requires separate item-by-item import approval, certification, or notification under Article 15(2). How foreign test and certification documentation can be used in the Korean procedure is laid out in the guide to CE marking and Korean approval.

Misconception 2: "Customs clearance was in the consumer's name, so I am not the seller." Whoever's name was used at customs, if the substance is supplying unregistered medical devices to Korean consumers, the issue remains exactly where it was. This structure is precisely the type the MFDS advises is illegal.

Misconception 3: "I paid for it with my own money, so reselling it is my own business." Article 26(1) prohibits not only sale but also giving away. Selling on a secondhand marketplace — and even handing devices out as free gifts or giveaways — can fall within the prohibition if the device is unregistered.

What do you need to sell lawfully?

The route is fixed. Put three things in place, in order.

Step	Procedure	Statutory fee	Practical notes
1. Business license	Import business license (Article 15(1))	KRW 144,000	Requirements such as a quality manager need review
2. Item registration	Item-by-item import approval, certification, or notification (Article 15(2))	Class 1 notification KRW 85,000 · Class 2 certification KRW 130,000	Class 1 typically 2–4 weeks; Class 2, 3–4 months
3. Sales notification	Sales business notification (Article 17(1))	KRW 10,000	Filed with the local government where the place of business is located

The statutory fees are the amounts under annexed Table 10 of the Enforcement Rule of the Medical Devices Act (electronic filing basis); separate actual costs such as testing fees are added depending on the item. The full picture of class-by-class procedures, timelines, and costs is in the class-by-class procedure overview.

There are exemptions from the sales business notification. An importer selling the devices it imported to medical device handlers, sales by pharmacy founders and pharmaceutical wholesalers, and sales of contraceptive medical devices and self-testing medical devices used outside medical institutions, as designated by Ordinance of the Prime Minister, among others, may proceed without notification (Article 17(2)). But this is an exemption from the sales business notification only — the item's own approval, certification, or notification obligation is a separate matter.

When converting an item you have been selling as a purchasing agent to formal registration, the first thing to check is the class. Even among similar "health products," a Class 1 item ends relatively quickly with a notification that involves no review, while a Class 2 or higher item — like blood pressure monitors with a measuring function — brings technical file review and import KGMP into play, and the scale of time and cost changes accordingly.

What CLARE Partners does

CLARE Partners handles the entire set of procedures needed to sell foreign products lawfully in Korea.

• Import business license service — from preparing and filing the application to reviewing facility and quality-manager requirements, agency fee from ₩2.0M
• Item registration service — Class 1 notification from ₩2.0M, Class 2 certification from ₩6.0M (statutory government fees itemized separately)
• Sales (rental) business notification service — document preparation and filing, agency fee from ₩0.5M
• Free pre-review — send us the product you plan to sell, and within 1 business day we give a first answer on whether it is a medical device, its class, and the procedures required

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

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For a purchasing-agent seller weighing formal registration, the fork in the road is a single question — does the item's share of your revenue justify the time and cost of registration? Send the item details through the regulatory consulting services page for a free pre-review, and we start by confirming the class, the required procedures, and the rough scale. Key terms that keep coming up across the registration process are collected in the glossary.

Statutory basis: Medical Devices Act (Act No. 21263, effective July 1, 2026) Article 15 (Import Business License, etc.) · Article 17 (Notification of Sales Business, etc.) · Article 26 (Prohibition of General Acts), paragraph 1 · Articles 51 and 52 (Penal Provisions) — based on the original texts in the National Law Information Center; details may change as statutes are amended. Statutory fees per annexed Table 10 of the Enforcement Rule of the Medical Devices Act. MFDS guidance: online monitoring of illegal medical device distribution (Korea Policy Briefing, March 7, 2025). The detailed customs criteria for personal-use import are matters for the customs authorities; this article covers only the sale-related regulation under the Medical Devices Act.