Medical Device Labeling Requirements in Korea — What Must Appear on the Package and Label

Key takeaway — Medical device manufacturers and importers must mark the container or outer casing with the nine items set by Article 20 of Korea's Medical Devices Act: company name and address, approval number and designation, lot number and date of manufacture, the words "medical device", the standard code (UDI), and more. Where outer packaging hides those markings, the same items must appear on the outer packaging as well (Article 21); the package insert must carry directions for use and precautions (Article 22); and Korean-language marking is the rule (Article 23). Distributing a device with nothing but the overseas manufacturer's original label breaks that rule. In vitro diagnostic (IVD) devices follow a separate statute that replaces the words "medical device" and adds the intended use and storage method to the container. Violations carry a fine of up to KRW 5 million (Article 54 of the Medical Devices Act; Article 31 of the IVD Act) — and the cheapest time to fix a label is before it is printed. Our labeling review starts from ₩0.5M.

What must appear on the label — the nine items of Article 20

It is tempting to think the work ends when the approval certificate arrives, but the moment the product reaches the market, what gets examined is not your paperwork — it is your packaging. Korea's labeling (labelling) requirements for medical devices sit in Article 20 of the Medical Devices Act, which directly enumerates what must appear on the container or outer casing.

There is a proviso. Where the surface of the container or casing is too small to carry everything, items may be moved to the outer packaging or the package insert — but even then, the model name and the company name must remain on the container or casing (Enforcement Rule, Article 42). "It was too small to print" does not translate into a blanket exemption.

How outer packaging differs from the package insert — Articles 21 and 22

Article 21 (outer packaging) is a one-sentence provision that catches people constantly in practice. If the markings on the container or casing cannot be seen because the outer packaging covers them, the same items must be marked on the outer packaging as well. The classic violation: unit labels fully compliant, while the box carries nothing but the brand logo.

Article 22 (package insert) is the instructions-side obligation. The insert must contain directions for use and precautions; matters concerning maintenance and inspection where required; matters the MFDS (Ministry of Food and Drug Safety) prescribes for inclusion in the applicable standards (Article 19); and the matters set by Ordinance of the Prime Minister — the product's intended use, storage and preservation methods, the date the insert was prepared, and the contact point for adverse event reports (the National Institute of Medical Device Safety Information), among others (Enforcement Rule, Article 43).

The insert can be provided on electronic media such as a USB drive or CD, not only on paper. Provision via a website, however, is limited to items the MFDS designates as devices used mainly in medical institutions (Article 22(2)). On a consumer product, replacing the paper insert entirely with "see the website for the manual" may not satisfy this requirement — so first confirm whether the item is on the designated list.

Can we use the English label as-is? — the Korean-language rule

The question we hear most often on imported devices. The answer sits in Article 23.

The matters prescribed in Articles 20 through 22 shall be indicated in a place where they can be seen more easily than other letters, articles, drawings, or designs, and shall be written accurately, in Korean, in terms that are easy to read and easy to understand, as prescribed by Ordinance of the Prime Minister. — Medical Devices Act, Article 23

Article 44 of the Enforcement Rule makes this concrete. The items must be written in Korean, or in Korean accompanied by Chinese characters or a foreign language of the same size, and there are only two exceptions — devices for export, labeled in the language of the destination country, and items written in a foreign language at the time of approval, certification, or notification, which may appear in that language. Details such as font size and line spacing are set separately by MFDS notification.

The practical implication is plain. A configuration that simply affixes the overseas manufacturer's original label and manual does not stand, and preparing Korean markings and a Korean package insert is part of the import process itself. Start that work on the eve of customs clearance and repackaging costs arrive together with schedule delays.

IVD labeling requirements in Korea — what changes under the IVD Act

If your product is a reagent, calibrator, control, or instrument used to examine specimens outside the body, the checklist above is not the one to print from. Since 2020, in vitro diagnostic medical devices have been governed by the In Vitro Diagnostic Medical Devices Act, and its labeling articles (Articles 13 to 15) rewrite the list. Anything the IVD Act does not itself provide falls back to the Medical Devices Act (Article 4 of the IVD Act) — which is why the Korean-language rule of Article 23 still applies to IVD labels.

Two of these differences do the damage in practice. First, the wording: an IVD kit that carries "medical device" copied from a general-device template is marked with the wrong statutory phrase. Second, the intended use and the storage method move from the insert to the container — on a reagent whose shelf life depends on refrigeration, the storage condition has to be readable without opening the box. Where QC is part of using the product, the insert must also say how to perform it (Article 15(1)2). Beyond the fine, incorrect markings under Articles 13 to 15 are grounds for licence revocation or business suspension of up to one year (IVD Act, Article 18(1)6). The IVD Act also lets the Ordinance exempt certain containers — small vials, for instance — from part of the list (proviso to Article 13), so check the Enforcement Rule of the IVD Act before deciding what a 2 mL bottle can leave off.

Whether your product falls under the IVD Act in the first place, and how its classes and clinical evidence differ from general devices, is covered in our IVD guide. A worked example of a consumer IVD sold at retail is in the pregnancy test kit guide.

Which items go missing — recurring review findings

Distilling the findings that come up again and again in label reviews:

• The words "medical device" — crowded out by brand elements at the design-draft stage (Article 20, subparagraph 6)
• Half of the single-use marking — "single use" present but "do not reuse" missing (subparagraph 7)
• The manufacturing source on imports — only the Korean importer's details, without the country of manufacture and the manufacturer's name (subparagraph 2)
• The UDI standard code — treated as identical to the approval number when it is a separate item (subparagraph 8)
• Markings hidden by the outer box — unit labels complete, the shipping carton bare (Article 21)
• The insert's date of preparation and the adverse-event contact point — directions for use carried over, the Ordinance items missed (Enforcement Rule, Article 43)
• IVD kits labeled from the general-device template — "medical device" instead of "in vitro diagnostic medical device", and the intended use and storage method left in the insert (IVD Act, Article 13)

The common thread is easy to spot. Most of these omissions happen not because anyone lacked the knowledge, but because no step existed for checking the label against the statutory list. A single cross-check before the print order prevents every one of them.

What sanctions follow — the two tiers of penalties

Sanctions for labeling violations split into two tiers by their nature.

In other words, what you left off and what you wrote wrongly carry different weights. Omitting a required item is a fine-level matter; the moment an unapproved efficacy claim lands on the label or insert, the statutory maximum climbs to three years' imprisonment. There is a distribution-chain ripple too — sellers and rental businesses are prohibited from selling or leasing a device that violates Article 24(1), and even from storing or displaying one for that purpose (Article 26(5)), so a label problem spreads beyond the manufacturer or importer into risk for distribution partners. The mirror-image problem — medical-device-sounding claims on ordinary products that are not medical devices — is covered in an earlier instalment in this series.

Where a violation is confirmed, corrective orders and recalls can follow as administrative measures separate from the criminal penalty — and in practice the largest cost is that an entire print run of packaging becomes rework. The right moment to finalize the label is immediately after registration is complete and before the packaging order goes out. To see where this step sits in the overall registration sequence for each class, see the procedure overview by class.

What CLARE Partners does

CLARE Partners checks labels against the statutory list before they are printed.

• Labeling review — the markings on containers, outer casings, outer packaging, and package inserts reviewed against the statutory requirements of the Medical Devices Act or, for IVDs, the IVD Act, from ₩0.5M
• UDI standard code registration — generation of UDI standard codes and registration in the Integrated Medical Device Information System handled for you, from ₩0.5M
• Free pre-review — send us your label draft and product information, and we reply within one business day with a first assessment of the required procedures and review scope

The full per-item fee schedule and how quotations are structured — together with the questions we are asked most often — can be found on the regulatory consulting services page.

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Unlike review documents, a label's cost of correction scales with the print run once it is printed. Before you place the packaging order, send a single PDF of your label draft for a free pre-review and we will check it against the Article 20–23 list — or the Article 13–15 list for an IVD — flagging what is missing first.

Legal basis: Medical Devices Act of Korea (Act No. 21263, in force 1 Jul 2026) — Article 20 (Matters to Be Indicated on Containers, etc.) · Article 21 (Matters to Be Indicated on Outer Packaging, etc.) · Article 22 (Matters to Be Stated in Package Inserts) · Article 23 (Precautions for Markings) · Article 24 (Prohibition of Markings and Advertising, etc.) · Article 26 (Prohibition of General Acts) · Articles 52 and 54 (Penalty Provisions) — and the Enforcement Rule of the Medical Devices Act (Ordinance of the Prime Minister No. 2127, in force 1 Jul 2026), Articles 42–44. In Vitro Diagnostic Medical Devices Act (Act No. 19920, in force 3 Jan 2026) — Article 4 (Relationship to Other Acts) · Article 13 (Matters to Be Indicated on Containers, etc.) · Article 14 (Matters to Be Indicated on Outer Packaging, etc.) · Article 15 (Matters to Be Stated in Package Inserts) · Article 18 (Revocation of Licences, etc.) · Article 31 (Penalty Provisions), text confirmed 22 Sep 2026. Based on the original Korean texts in the National Law Information Center; the content may change as the legislation is amended.