Medical Device Sales Business Notification in Korea — When It Is Required and When You Are Exempt

Key takeaway — Anyone who intends to sell medical devices as a business must file a sales business notification for each place of business with the competent local government — the mayor of a special self-governing city, the governor of a special self-governing province, or the head of the si/gun/gu — where that place of business is located (Medical Devices Act, Article 17(1)). Exemptions apply where a pharmacy founder or pharmaceutical wholesaler does the selling, where a manufacturer or importer sells its own products to medical device handlers, and where the items sold are those designated by Ordinance of the Prime Minister, such as condoms (Article 17(2)). The statutory fee is KRW 10,000 (KRW 9,000 for electronic filing), and the acceptance decision is notified within 3 days of receipt (Article 17(4)). Running a sales business without notification is punishable by imprisonment of up to 3 years or a fine of up to KRW 30 million (Article 52(1)).

Who has to file a sales business notification

In the previous article we noted that using medical-device claims requires a sales business notification separate from product registration — and promised a follow-up. This is that follow-up. The starting point is Article 17(1) of the Medical Devices Act.

A person who intends to sell medical devices as a business (a "seller") or to rent them as a business (a "rental business operator") shall, for each place of business, file a sales business notification or a rental business notification with the mayor of the special self-governing city, the governor of the special self-governing province, or the head of the si/gun/gu (meaning the head of an autonomous gu; the same applies hereinafter) having jurisdiction over the location of the place of business, as prescribed by Ordinance of the Prime Minister. — Medical Devices Act, Article 17(1)

Three points need underlining.

First, the test is whether you sell "as a business." If you sell repeatedly and continuously for profit, you are within scope. The typical case is a seller on Naver Smart Store or Coupang who buys in products registered as medical devices — medical compression stockings, manual wheelchairs, and the like — and keeps selling them.

Second, the unit is "each place of business." The notification is filed per place of business, not per company, and the receiving authority is not the MFDS but the si/gun/gu office where the place of business is located.

Third, selling online is no exception. The provision does not distinguish between sales methods. If anything, the Enforcement Rule contains a special provision on the place of business specifically for e-commerce and mail-order sellers, which we come back to below.

How far do the exemptions reach

Article 17(2) of the Medical Devices Act provides that "in any of the following cases, the notification under paragraph (1) may be dispensed with," and lists four. In the order of the statutory text:

Exemption (Article 17(2))	Scope and conditions
① A manufacturer or importer sells or rents the devices it manufactured or imported to medical device handlers	Exempt only when the counterparty is a medical device handler. Direct sales to general consumers are not covered
② A person who has filed a sales business notification also runs a rental business	One sales business notification stands in for the rental business notification
③ A pharmacy founder or a pharmaceutical wholesaler sells or rents medical devices	No separate sales business notification required
④ Selling contraceptive medical devices and self-testing medical devices used outside medical institutions, as designated by Ordinance of the Prime Minister	Limited to the items in Article 38 of the Enforcement Rule. Only ‘selling’ is exempt (rental is a separate matter)

The one that gets misread most often in practice is ①. The exemption is confined to sales "to medical device handlers." Medical device handlers means manufacturers, importers, repairers, sellers, and rental business operators licensed or notified under this Act, together with founders of medical institutions under the Medical Service Act and founders of veterinary clinics under the Veterinarians Act (Article 2(3)). In other words, an importer supplying hospitals and dealers is exempt, but the moment it starts selling the same product directly to general consumers through its own online store or an open marketplace, it steps outside this exemption and a sales business notification becomes necessary. The import business license and the sales business notification are separate procedures.

For ③, picture a pharmacy selling thermometers and masks alongside its medicines. Pharmacy founders and pharmaceutical wholesalers are already managed under their own establishment-registration and licensing regimes, so a separate medical device sales business notification is not demanded of them.

Exempt items — what exactly does "designated by Ordinance of the Prime Minister" mean

The items under ④ are set by Article 38 of the Enforcement Rule of the Medical Devices Act. The text currently in force (effective July 1, 2026) reads:

Article 38 (Exemption from Sales Business Notification, etc.) The medical devices that may be sold without the notification under Article 17(2)4 of the Act are as follows:

1. Condoms
2. Blood glucose meters whose glucose-measuring function is embedded in, or used in combination with, mobile phones, home appliances, and similar products
3. Other medical devices designated by public notice of the Minister of Food and Drug Safety in consideration of the degree of risk and safety

Two cautions.

One: item 3 is a delegation to public notice. The only items named in the Rule itself are condoms and glucose meters embedded in or combined with mobile phones and home appliances; the rest are designated by MFDS public notice. So "is my item exempt" can never be settled from the Rule alone — you have to check the notice text in force at the time of sale. Exempt items can be added or removed by amendment, which is why trusting an item list from a blog post written years ago is the riskiest move of all.

Two: the exempted act is 'selling'. Article 38 speaks of devices "that may be sold without the notification," and Article 17(2)4 of the Act likewise says "where … sells." Even for the same item, a rental business sits outside the wording of this exemption.

I only sell online — do I still need a 'place of business'?

The first field on the notification form is the address of the place of business, and this is where online sellers operating from home, without an office, tend to stall. A special provision created in 2024 solved the problem: a person who intends to sell medical devices by e-commerce or mail order may use a residential building or a business incubator as the place of business (Enforcement Rule, Article 37(2), inserted July 8, 2024). In plain terms, you can file under your home address.

Compared with class-based product registration, the procedure is on the simple side.

Item	Details
Where to file	The si/gun/gu office with jurisdiction over the place of business (electronic filing available)
What to submit	Sales business notification form (annexed form of the Enforcement Rule)
Statutory fee	KRW 10,000 — KRW 9,000 when filed electronically (annexed Table 10 of the Enforcement Rule; Government24 guidance)
Processing	Acceptance decision notified within 3 days of receipt — if no notice of acceptance or of an extension of the processing period arrives within that period, the notification is deemed accepted on the day after the period ends (Article 17(4)–(5) of the Act)
What you receive	Sales business notification certificate

Once the notification is accepted, a certificate is issued — and this certificate is precisely the document that Coupang and Naver Smart Store typically require in their medical device category onboarding review. Keep in mind, too, that changes to what you notified (trade name, address, and so on) trigger an amendment notification (Enforcement Rule, Article 37(4)).

What happens if I sell without filing

A breach of Article 17(1) — running a sales or rental business without notification — carries imprisonment of up to 3 years or a fine of up to KRW 30 million under Article 52(1) of the Medical Devices Act. That is a criminal penalty, not an administrative fine. A weight entirely out of proportion to skipping a procedure whose fee is KRW 10,000.

Platform risk moves on a separate track. Open marketplaces generally run their medical device categories on the premise that a sales business notification certificate has been submitted, so once a missing notification comes to light, it can lead to delisting and account sanctions regardless of how the criminal issue plays out.

Product registration and the sales business notification — do I need both?

The last point of frequent confusion. Medical device distribution runs on two tracks.

• Product track — has the product itself completed, according to its class, a Class 1 notification, a Class 2 certification, or a Class 3·4 approval? This is the manufacturer's or importer's procedure; class-by-class procedures, timelines, and costs are laid out in the class-by-class procedure overview.
• Seller track — do I, the person selling the product, hold a sales business notification? That is the subject of this article, and it is the seller's own procedure.

If you are a resale seller, check each track separately: on the product track, whether the manufacturer or importer has already finished it (verify the approval, certification, or notification number); on the seller track, whether you fall under an exemption. The separate problem of using medical-device claims on ordinary consumer goods was covered in the previous article, and the key terms that keep coming up across the registration process are collected in the glossary.

What CLARE Partners does

CLARE Partners covers both the seller track and the product track.

• Sales (rental) business notification service — from drafting the notification and preparing the documents to filing with the competent local government, agency fee from ₩0.5M (the statutory fee of KRW 10,000 itemized separately)
• Class 1 notification service — where product registration is needed as well, from document preparation to filing, agency fee from ₩2.0M (statutory fee of KRW 85,000 itemized separately)
• Free pre-review — send us the item you plan to sell and how you plan to sell it, and within 1 business day we give a first answer on whether a sales business notification is required and whether an exemption applies

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

---

Starting to sell while it is still ambiguous whether you are exempt is the most expensive way to find out. Send your item details and sales channels through the regulatory consulting services page for a free pre-review — we start by confirming whether a notification is required and which exemption clause, if any, you fall under.

Statutory basis: Medical Devices Act (Act No. 21263, effective July 1, 2026) Article 2 (Definitions) · Article 17 (Notification of Sales Business, etc.) · Article 52 (Penal Provisions); Enforcement Rule of the Medical Devices Act (effective July 1, 2026) Article 37 (Notification of Sales or Rental Business, etc.) · Article 38 (Exemption from Sales Business Notification, etc.) · Article 65 (Fees) and annexed Table 10 — based on the original texts in the National Law Information Center. For the in-person and electronic filing fee amounts, the Government24 guidance on the medical device sales (rental) business notification was also consulted. Details may change as statutes and public notices are amended.