Medical Device Advertising Review in Korea — What Is Covered and What Is Exempt

Key takeaway — Start with the name. Article 25 of the Medical Devices Act is titled "Self-Regulatory Review of Advertising." It is not a structure where a government body screens in advance, but one where a review body that has filed notification with the Minister of Food and Drug Safety conducts the review. Four things matter in practice: the six media categories, the exemptions, the three-year validity, and re-review on change. Current as of September 2026.

Search results still show the old system

Search this topic and you will find plenty of material describing "MFDS pre-screening." That material is out of date.

The current provision is titled self-regulatory review, and the reviewer is not an administrative agency but a self-regulatory review body — defined as an institution or organisation that has filed notification with the Minister of Food and Drug Safety under Article 25-2(1). Notification, not designation, tells you something about how the scheme is built.

The practical consequence is concrete: review is filed with a private body, and the fee is paid to that body (Article 25(6)).

1. What is covered — six media categories

Article 25(1) defines scope by medium:

	Medium
1	Television and radio broadcasting under the Broadcasting Act
2	General daily and weekly newspapers, internet newspapers, magazines
3	Outdoor advertising in the form of banners, posters and leaflets, and displays on transport facilities and vehicles (including interior displays and combinations of video, voice and sound)
4	Electronic display boards
5	Internet media specified by Presidential Decree (including mobile applications)
6	Other advertising media specified by Presidential Decree, considering the nature and influence of the medium

The row to check first is 5. Most medical device advertising now happens online, and that scope is fixed not by the statute but by the Presidential Decree — so "does our channel fall inside" is answered by the decree, not the article.

One misunderstanding worth clearing up: a medium outside the list does not mean any wording is acceptable. Article 25 only settles whether prior review is required; the content prohibitions in Article 24 apply regardless of medium. Which expressions get caught is covered in the advertising rules guide.

2. Exemptions — this is the fork

Article 25(3) lists advertising that does not require review:

1. Advertising consisting solely of the content approved, certified or notified (Article 6(2) or Article 15(2))
2. Foreign-language advertising for devices manufactured solely for export
3. Foreign-language advertising identical to content already reviewed
4. Advertising directed at professional groups such as healthcare practitioners, and other content specified by Presidential Decree

Item 1 is the most important sentence in this guide.

Build the product page strictly within the scope of the approved particulars and no review procedure is needed. Go one line beyond, and depending on the medium the advertisement becomes subject to review.

The implication is larger than it looks. How far the copy goes stops being a marketing question and becomes a procedural one — "let us emphasise the effect a little more" is also a decision to add a procedure.

A workable order:

1. Draft a baseline text taken directly from the approved particulars → confirm the exemption applies
2. List the expressions you want to add on top of it
3. For each, check whether it exceeds the approved scope, and which medium it will run in
4. File review only for the combinations that need it

3. Three-year validity — the provision people miss

Review is not a one-off.

• Validity is three years from the date of approval (Article 25(7))
• To continue, file again with the self-regulatory review body six months before expiry (Article 25(8))
• Changing reviewed content requires re-review, minor matters excepted (Article 25(2))

Those three lines are where accidents happen. Three years is long enough for the responsible person to change at least once, and a six-month-before-expiry deadline is easy to miss unless it is on a calendar. A company running several advertising assets is better off keeping a register of approval and expiry dates.

The same goes for re-review on change. Product pages are assets that get edited often, and judging where "minor matters" ends takes a check. Making that check a habit saves time in the end.

4. If you contest the outcome — 30 days

• Re-review by the self-regulatory review body, within 30 days of notification (Article 25(4))
• Objection to the Minister of Food and Drug Safety (Article 25(5))

Thirty days is short. Decide whether to contest as soon as the result arrives.

5. If you sell online, read these together

For a company selling devices online, advertising sits in three layers:

• Who sells — whether a sales business notification is needed: sales business notification guide
• What may be said — the content prohibitions: advertising rules guide
• Whether review is required — this guide

Each comes from a different provision, so resolving one does not carry the others.

Common mistakes

• Following old material in search of "MFDS pre-screening" and approaching the wrong body
• Losing the exemption over a single expression that exceeds the approved particulars
• Obtaining review and then not managing the three-year validity
• Editing a product page without considering re-review on change
• Reading a medium's absence from the list as an absence of Article 24 content rules

Before you start

• List the media you will advertise in → check each against Article 25(1) (for internet media, down to the decree)
• Draft the baseline text from approved, certified or notified particulars → test exemption item 1
• List expressions beyond the baseline → map which combinations need review, by medium
• Align fee responsibility and lead time with the campaign schedule
• Keep a register of approval and expiry dates → set a reminder six months before expiry
• Build a re-review check into the product page editing process

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Advertising copy is simplest to administer when it is designed within the scope of the approved particulars. Send the claims you intend to make together with the approved, certified or notified particulars, and we will identify what falls inside the exemption and which media trigger review — see free preliminary review.