Korean Medical Device Labeling and Instructions for Use Requirements

1. Key takeaways

Korea distributes labeling obligations across 4 provisions: labeling on containers and the like (Article 20), outer packaging labeling (Article 21), leaflet labeling (Article 22), and labeling requirements (Article 23). The first three each govern one physical carrier, while Article 23 governs presentation, requiring prominent placement and labeling in accurate, easily understandable Korean. Because the three carriers rest on independent provisions, missing any one layer constitutes a labeling violation – not merely a missing content item.

• The layer Chinese manufacturers miss most often is the outer packaging under Article 21: the container label is done, but the outer packaging reuses the domestic layout, leaving statutory items missing at the outer packaging layer.
• Electronic leaflets are not an optional alternative for all categories. Information for digital medical device software must be provided electronically under the Digital Medical Products Act (enacted and promulgated January 23, 2024, effective January 24, 2025 for digital medical devices); ordinary devices cannot rely on it to switch to a purely electronic leaflet (practical estimate).

2. Legal basis

The instruments below allocate the labeling duties across the three carriers and the presentation requirement, and fix the electronic delivery rule for digital medical device software. Regulatory information verified as of October 29, 2026.

Division of labour among the three labeling layers. Each carrier carries its own statutory items, and each has its own typical gap.

3. Expert insights

Three carrier provisions plus one meta-provision; the self-check order should start with the outer packaging. Articles 20 to 22 govern the container, the outer packaging and the leaflet respectively, while Article 23 adds no labeling items but constrains the presentation under those three. Companies habitually start self-checks at the container label, and the outer packaging has the highest miss rate. Container labels and outer packaging are often printed by different suppliers; when the two layouts diverge, missing items concentrate on the side printed later. GRZAN fixes the pre-release verification order at 4 steps: container, outer packaging, leaflet, and then a return to Article 23 for a presentation review.

Article 23 constrains content, not only language. The phrase of labeling accurately and understandably in Korean carries two requirements: accurate correspondence with the licensed content, and comprehensibility for Korean users. Translating the Chinese leaflet sentence by sentence into Korean tends to violate both at once – wording inconsistent with the licensed scope, and sentence patterns that do not fit Korean usage conventions. Stiff literal translation alone is not necessarily a violation, but wording inconsistent with the licensed scope directly constitutes one. The GRZAN approach is to have the Korean text checked by the quality manager of the licence holder, not self-checked by the translation vendor; where Korean wording diverges from the licensed documents, the licensed documents prevail.

Container labeling shares Article 20 with UDI; the artwork and the data must be the same version. Article 20 of the Medical Device Act is both the basis for container labeling and the legal basis for the medical device standard code (Act No. 14330, amended December 2, 2016). This means the container artwork and the IMDIS data must change in lockstep: updating either side alone creates an information mismatch at the import clearance stage, and the problem surfaces at clearance first, see Article 25: Medical device standard code (UDI) – assignment, data submission and deadlines and Article 35: Import declaration and customs clearance.

Labeling responsibility rests with the licence holder, not the translation stage. The statutory responsibility for Korean labeling is borne by the licence holder, with supervision performed by the quality manager. Handing Korean labeling entirely to a translation vendor and starting production without licence holder review leaves the risk with the party least able to control it (practical estimate: internal review workflows may be scaled to company size, but the responsible party cannot be transferred). Once labeling goes into production, recalls and administrative liability remain with the licence holder, not the translator.

4. Practical recommendations

• Build a separate verification sheet for each of the four provisions. One sheet each for container, outer packaging, leaflet and presentation, not one merged master sheet; keeping the four sheets separately leaves a trail that traces back to the specific step afterwards.
• Have the Korean text countersigned by the licence holder before layout. Fix the wording first, then do the graphic design; this avoids rework when text changes after layout is frozen. Sending text to layout before it is final means one change moves the entire layout.
• Change container artwork and UDI data in lockstep. When the standard code changes, handle the container artwork and the IMDIS data in the same change order with matching version numbers; the database must be modified within 10 days of the change.
• Keep the labeling scope within the licensed content. Indications, usage and precautions must match the Technical Document and the licensed content; any additional claim creates a new risk and breaches advertising rules a second time.
• Deliver digital medical device software electronically. Information under digital medical device software must be provided electronically (Digital Medical Products Act, effective January 24, 2025), and a paper leaflet does not apply to this category (practical estimate); labeling and delivery for these products carry further requirements, see Article 28: Documentation requirements for software medical devices and AI devices.

5. Verification checklist

• □ Container labeling items: check item by item against Article 20; statutory items complete, including the standard code.
• □ Outer packaging labeling items: check item by item against Article 21; statutory items complete, overseas layout not reused.
• □ Leaflet labeling items: check item by item against Article 22; statutory items complete, consistent with the Technical Document.
• □ Presentation: check placement and readability against Article 23; prominent placement, Korean accurate and understandable.
• □ Consistency with IMDIS data: compare container labeling against the database record; item name and standard code identical in both places.
• □ Labeling scope: compare against the Technical Document and the licensed content; no claims beyond the licensed scope.
• □ Korean countersignature: verify the countersigning party; countersigned by the quality manager of the licence holder.
• □ Electronic leaflet applicability: determine whether the product is digital medical device software; products in this category delivered electronically, other categories keep paper (practical estimate).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, Korean licence holder and local testing support for the Republic of Korea. Our team prepares MFDS-compliant technical dossiers, coordinates KGMP documentation, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com