What You May and May Not Say on a Listing Page — Advertising Rules for Medical Devices

Key takeaway — Part 1 of this series dealt with products that are not medical devices being advertised as if they were; this time the rules run the other way — the advertising rules for a registered medical device. Medical device advertising is permitted only within the scope of the approved, certified, or notified particulars, and false or exaggerated advertising and expressions that risk being read as endorsement by healthcare professionals are prohibited (Article 24(2) of the Medical Devices Act). Open-market listing pages such as Coupang and Naver Smart Store count as media subject to self-regulatory ad review, so in principle the review comes first; an ad composed solely of the approved particulars may run without review (Article 25). Violations are punishable by imprisonment of up to three years or a fine of up to KRW 30 million (Article 52).

Now that we are registered, can we advertise freely?

The problem Part 1 of this series dealt with was misleading advertising of things that are not medical devices. One of its conclusions was “if the claim matters to your business, register the product as a medical device” — and the moment registration is complete, a rulebook pointing the opposite way starts to apply. Advertising rules that exist precisely because the product is a medical device.

The core principle is a single sentence. Registration buys you the range of things you may lawfully say — not the right to say anything at all. Where that range ends, and what procedure (prior self-regulatory review) has to come before you speak, is what this article covers.

Where is the advertising boundary written? On your approval certificate

Article 24(2)(5) of the Medical Devices Act prohibits the following advertising.

Advertising concerning the name, manufacturing method, performance, or efficacy and effects of a medical device for which approval or certification under Article 6(2) or Article 15(2) has not been obtained, or which differs from the notified particulars — main text of Article 24(2)(5) of the Medical Devices Act (proviso omitted)

In other words, the intended use and the performance and efficacy wording on the approval certificate (or certification or notification certificate) are the boundary line for your listing copy. If the product is approved for “pain relief through low-frequency stimulation,” expressions within that scope are possible — but the moment you add “body fat reduction” or “improved blood circulation” that appears nowhere in the approved particulars, a violation issue arises under item 5. Whether the product actually has that effect is a separate question — same as in Part 1.

The weight is the same too. A violation of Article 24(1) or 24(2) is punishable under Article 52(1)(1) of the Act by imprisonment of up to three years or a fine of up to KRW 30 million, and the two can be imposed together (Article 52(2)). And it is not only about advertising — Article 24(1) also prohibits placing on the container, exterior, packaging, or accompanying documents anything false or liable to mislead, or performance and efficacy different from the approved particulars. That is why fixing a listing page means checking the label and the accompanying documents at the same time.

Which expressions are prohibited — the Article 24(2) catalogue

Prohibited type (Article 24(2))	Examples that tend to trip listing pages
False or exaggerated advertising (item 1)	Categorical efficacy claims beyond the approved scope, inflated performance
Ads that risk being read as endorsement, recommendation, or official recognition by healthcare professionals and the like (item 2)	“Recommended by doctors,” “the very device hospitals use”
Articles, photos, or graphics that hint at efficacy (item 3)	Before-and-after photos, screenshots of papers or news articles implying efficacy
Suggestion of abortion; obscene documents or images (item 4)	Any such expression
Advertising that differs from the approved, certified, or notified particulars (item 5)	Adding efficacy absent from the approved intended use
Advertising that skipped self-regulatory review or differs from the reviewed content (item 7)	An ad placed on covered media without review

Two caveats. One, the right-hand column is illustrative only; whether an individual claim is unlawful is judged from the ad as a whole. Two, items 2 and 3 are where sellers stumble most often. Even inside the approved efficacy scope, leading with a healthcare professional’s endorsement, or implying efficacy through articles, papers, or before-and-after photos, is itself a prohibited type. Alongside “what you say,” “how you say it” is regulated too.

Does a listing page need review? The prior self-regulatory review system

The medical device ad review system went through one major turn. The old Article 24(2)(6), the basis for government-led prior review, was ruled unconstitutional by the Constitutional Court on August 28, 2020, and the amendment of March 23, 2021 (Act No. 17978) deleted the item, creating today’s self-regulatory review system. Review is now conducted by institutions and organizations notified to the MFDS — the self-regulatory review bodies (Article 25-2) — and an ad that has not been reviewed is prohibited again through Article 24(2)(7), as in the table above. “Self-regulatory” in name, on covered media it is in practice a gate an ad must pass before running.

So which media are covered? Filtering the list set by Article 25(1) of the Act and Article 10-3 of the Enforcement Decree down to what matters to an online seller:

Category	Content (basis)
Covered media	TV and radio broadcasting, general daily and weekly newspapers, internet newspapers, magazines, banners, wall posters, leaflets, transit ads, electronic display boards (Article 25(1)(1)–(4) of the Act)
Internet media	Internet news services, broadcasters’ websites, internet media operated by mail-order sellers or mail-order brokers — open markets and Smart Store fall here (Article 10-3(1) of the Enforcement Decree)
SNS	SNS ad media with a daily average of 100,000 or more users over the three months preceding the end of the previous year (Article 10-3(2) of the Enforcement Decree)
Exemptions from review	① Ads composed solely of the approved, certified, or notified particulars ② Foreign-language ads exclusively for export ③ Foreign-language ads identical to reviewed content ④ Ads aimed at healthcare professionals and other experts (Article 25(3) of the Act)
Validity period	Three years from the approval date; to keep advertising, reapply six months before expiry (Article 25(7)–(8) of the Act)
Changing content	Re-review in principle. The only exceptions: wording edits, deletions, or layout changes that do not alter the substance, and changes tracking a change approval, change certification, or change notification (Article 25(2) of the Act; Article 10-3(3) of the Enforcement Decree)

For an online seller the real fork is exemption ①. Compose the listing page solely of the approved intended-use and efficacy wording, and you can go without review. Start paraphrasing that wording into consumer language and expressing efficacy through usage-scene images and graphics — which is what most listing pages do — and the safe assumption is that you are on the review track. The review fee is not a statutory amount; each self-regulatory review body sets its own (Article 25(6)), and the MFDS is required to publish on its website which organizations have been notified as review bodies (Article 10-5(5) of the Enforcement Decree).

Three checks before you build the listing page

Step 1 — Check against the certificate. Place the listing copy (search keywords and in-image text included) side by side with the intended use on the approval, certification, or notification certificate. Efficacy claims outside the approved particulars, healthcare professional endorsements, before-and-after photos, and article quotes get filtered out at this step.

Step 2 — Decide whether review is needed. If the page is composed solely of the approved particulars, it is exempt from review. If you have paraphrased the wording or expressed efficacy through visual material, obtain review from a self-regulatory review body before publishing. For reviewed ads, put the three-year validity period and re-review on changes onto your management checklist.

Step 3 — Sync the label and accompanying documents. If an expression you fixed in the ad still sits on the container, packaging, or accompanying documents, it becomes an Article 24(1) issue. Bring the labeling up to the same standard.

For the full picture of procedures, timelines, and costs by class, see the procedure overview by class; key regulatory terms are collected in the glossary.

What CLARE Partners does

CLARE Partners handles the stage before the ad goes live.

• Ad prior-review agency service — preparing the prior-review application for medical device advertising and handling the review process, agency fee from ₩0.5M (the review body’s fee is itemized separately)
• Labeling review — checking the labeling on containers, packaging, and accompanying documents against the statutory requirements, from ₩0.5M
• Free pre-review — send your certificate and listing page draft, and within 1 business day we give a first-pass answer on expressions that exceed the approved scope and whether review is required

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

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Fix the ad copy after the listing page design is finished, and the image work has to be redone as well. The cheapest moment to pin down the approved scope and the need for review is at the copy draft stage. Send your certificate and draft copy for a free pre-review, and we will start by flagging the expressions that would get caught and the procedures you need.

Governing statutes: Medical Devices Act (Act No. 21263, effective July 1, 2026) Article 24 (Prohibition of Labeling and Advertising, etc.) · Article 25 (Self-Regulatory Review of Advertising) · Article 25-2 (Composition and Operation of Self-Regulatory Review Bodies, etc.) · Article 52 (Penal Provisions) · Enforcement Decree of the Medical Devices Act (Presidential Decree No. 36445, effective July 1, 2026) Article 10-3 (Advertising Subject to Self-Regulatory Review) · Article 10-5 (Composition of Self-Regulatory Review Bodies) — based on the original text in the National Law Information Center; the content may change as the statutes are amended.