Not Everyone Gets to Say ‘Medical Device’ on Coupang — Where Consumer Products End and Medical Devices Begin

Key takeaway — Labeling or advertising that makes a non-medical-device product look as though it has the performance or efficacy of a medical device is prohibited by Article 26(7) of Korea’s Medical Devices Act, and a violation is punishable under Article 52 by imprisonment of up to three years or a fine of up to KRW 30 million. The provision bans not only the labeling and advertising but also the sale and display of products labeled or advertised that way. The legal route to words like “treatment” and “medical-grade” is registering the product as a medical device — and for Class 1 that is a notification with no review, so the barrier is lower than most sellers expect: statutory fee KRW 85,000, statutory processing period 5 days, typically 2–4 weeks in practice.

“I want to say it treats pain” — but my product is a consumer good

Massage guns, posture-correction bands, heat packs, low-frequency stimulation patches. If you sell health-adjacent products on Coupang or Naver Smart Store, you have stood in front of this temptation at least once: write “relieves pain,” “improves blood circulation,” or “medical-grade” on the listing page, and clicks and conversions change visibly.

The problem is that the moment you use those words, the product’s character changes in the eyes of the law. Article 26(7) of the Medical Devices Act provides as follows.

No person shall place, on the exterior, packaging, or accompanying documents of anything that is not a medical device, labeling that risks being misperceived as indicating performance, efficacy, or effects similar to those of a medical device, or run advertising with such content; nor shall any person sell or lease anything so labeled or advertised, or store or display it for the purpose of sale or lease. — Medical Devices Act, Article 26(7)

From an online seller’s standpoint, three points deserve attention.

First, the subject is “no person.” This is not a manufacturer-only problem. A seller who buys in someone else’s product and resells it, or a consignment seller, is equally bound by this provision.

Second, it prohibits sale and display, not just labeling and advertising. Even if you did not write the listing copy yourself, putting a product carrying such copy up for sale is itself within the prohibition.

Third, the penalty is not light. A violation of Article 26(7) carries, under Article 52(1) of the Act, imprisonment of up to three years or a fine of up to KRW 30 million, and imprisonment and fine can be imposed together (Article 52(2)). This is a criminal penalty, not an administrative fine — which is what sets its weight apart from other advertising rules.

Which claims cross the line

The test is not the product’s material or actual performance but the intended use it claims. Article 2(1) of the Medical Devices Act defines a medical device as a product used for the purposes below. Hold your listing copy against this definition and the boundary becomes visible.

Element of the statutory definition (Article 2(1))	Claims that tend to raise misperception issues
Diagnosis, treatment, alleviation, management, or prevention of disease	“treats ○○,” “prevents disease,” “pain treatment”
Diagnosis, treatment, alleviation, or correction of injury or impairment	“corrects forward head posture,” “for rehabilitation therapy”
Examination, replacement, or modification of structure or function	“improves blood circulation,” “reshapes the body,” “restores muscle function”
Control of conception	Claims of conception-control effects

Two reminders go together. One, whether the product actually has the effect is a separate question. The claim that risks misperception is itself the prohibited act. Two, the table is only illustrative; whether an individual claim is unlawful is judged from the listing page as a whole — photos, reviews, and search keywords included. Drop the word “medical-grade” and the same issue can still arise if the overall impression reads like a medical device.

“Coupang approved my listing, so it must be legal” — three common misconceptions

Misconception 1 — “Everyone in the category writes this.” The fact that other sellers in the same category use the same claims has no bearing on whether your labeling and advertising are lawful. A competitor’s copy is not a benchmark — it may simply be another listing carrying the same risk.

Misconception 2 — “The platform approved my listing, so it is legal.” Platform category approval and listing review are one procedure; compliance with the Medical Devices Act is another. Platform policy is a contractual matter between the platform and the seller; the Medical Devices Act is a statutory matter between the state and the seller. Passing listing review confirms nothing about statutory compliance — and conversely, claims that are legally unproblematic are sometimes restricted by platform policy.

Misconception 3 — “I just need to phrase around it.” What is prohibited is not a specific word but the “risk of misperception.” Detour through emojis, abbreviations, or metaphor (“fewer trips to the hospital”) and the issue remains exactly where it was, as long as consumers would take away the impression of medical-device-like efficacy.

Using medical device claims legally — the registration option

There is also a road in the opposite direction. If the claim genuinely matters to your business, register the product as a medical device. A registered device may label and advertise its performance and efficacy within the scope of its approved, certified, or notified intended use (medical device advertising then goes through a separate prior review system).

The good news: a large share of the health-adjacent products online sellers handle are candidates for Class 1, the lowest-risk tier. Class 1 is the only one of the four classes that proceeds as a notification, with no review.

Item	Detail
Procedure	Product notification (no technical file review)
Statutory fee	KRW 85,000 (e-filing basis)
Statutory processing period	5 days
Practical lead time	Typically 2–4 weeks including document preparation

The four steps of the notification and the points where filings commonly bounce are covered in the Class 1 medical device notification guide; for the full picture of procedures, timelines, and costs by class, see the procedure overview by class.

There is one more track. Separate from product registration, anyone intending to sell medical devices must in principle file a sales business notification with the local authority that has jurisdiction over their place of business (Article 17(1) of the Medical Devices Act, statutory fee KRW 10,000). The Act does carve out exemptions — sales by pharmacy operators or pharmaceutical wholesalers, and certain product categories prescribed by Ordinance of the Prime Minister, among others (Article 17(2)). Whether your case is exempt, and how the notification works for online selling, will be covered separately in Part 4 of this series.

One caution. Registration is not a master key. Even after registration, labeling and advertising are permitted only within the scope of the approved intended use, and exaggerated claims beyond that scope run straight into medical device advertising regulation instead. Registration buys you the range of things you may lawfully say — not the right to say anything at all.

What should I check right now — a three-step self-audit

Step 1 — Check against the definition. Hold your listing copy (search keywords and reviews included) up against the Article 2 definition table above. If nothing claims effects on disease, injury, or bodily structure and function, you are within consumer-product territory and the issue in this article does not arise.

Step 2 — Confirm the class. If you want to keep the claim, confirm which class your product would fall under when registered for that intended use. Class 1 is relatively simple via notification, but features like measurement functions or sterile supply can push a product to Class 2 or higher — and then the certification and approval procedures, timelines, and costs change in scale.

Step 3 — Choose your fork. If the claim is not decisive for revenue, editing the copy back into consumer-product territory is the fastest fix. If the claim is core to the business, take the registration track (product notification plus sales business notification). The test is a single question — is that claim worth the time and cost registration takes?

What CLARE Partners does

CLARE Partners covers both sides of this fork.

• Class 1 notification service — from document preparation to filing, agency fee from ₩2.0M (the government statutory fee of KRW 85,000 is itemized separately)
• Sales (rental) business notification service — document preparation and filing, agency fee from ₩0.5M
• Free pre-review — send your product details and the claims you want to use, and within 1 business day we give a first-pass answer on medical device status, class, and required procedures

The full fee schedule by service item and how quotes are structured are on the regulatory consulting services page.

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Whether to change the copy or register the product is cheapest to decide at the sourcing and planning stage — not after the listing page is finished. Send your product details and intended claims for a free pre-review, and we will start by confirming whether you can stay within consumer-product territory — and if you register, which class you are looking at.

Governing statute: Medical Devices Act (Act No. 21263, effective July 1, 2026) Article 2 (Definitions) · Article 17 (Notification of Sales Business, etc.) · Article 26 (Prohibited Conduct), Paragraph 7 · Article 52 (Penal Provisions) — based on the original text in the National Law Information Center; the content may change as the statute is amended. The sales business notification fee follows attached Table 10 of the Enforcement Rule of the Medical Devices Act.