Korea Medical Device Labeling: MFDS Korean-Language Requirements
MFDS labeling requirements differ from CE Mark and FDA. Here's the complete Korean labeling framework — required elements, formatting, and common compliance gaps.
The Korean Labeling Framework
Korean labels must be in Korean. Translation of English/CE labels alone does not satisfy MFDS — labels must be built from Korean requirements, not translated from foreign labels.
The 14 Mandatory Label Elements
Per MFDS Notice 2022-110, medical device labels must include:
| # | Element | Korean Term |
|---|---|---|
| 1 | Product name | 제품명 |
| 2 | Model name | 모델명 |
| 3 | KMD number (MFDS Product License) | 의료기기허가번호 |
| 4 | KLH name (Korea License Holder) | 국내대리인 |
| 5 | KLH address (Korean) | 국내대리인 주소 |
| 6 | Manufacturer name | 제조원 |
| 7 | Manufacturer address (country level minimum) | 제조원 주소 |
| 8 | Manufacturing date | 제조연월일 |
| 9 | Expiration date or lot/serial | 사용기한 또는 제조번호 |
| 10 | Storage conditions (Celsius, Korean format) | 보관조건 |
| 11 | Warning statements (Korean, MFDS-approved phrasing) | 주의사항 |
| 12 | Single-use indicator (if applicable) | 일회용 |
| 13 | Sterility status (if applicable) | 멸균 상태 |
| 14 | Reference to IFU | 사용설명서 참조 |
Korean Language Requirements
What "Korean Language" Means
- All mandatory label text in Korean
- Korean characters (Hangul, with optional Hanja for technical terms)
- Bilingual labels (Korean + English) acceptable as long as Korean is primary
- Translation must be regulatory-quality, not generic translation
Common Korean Language Mistakes
| Mistake | Why It Fails |
|---|---|
| Translated English warnings literally | Korean expects specific approved phrasings |
| Mixed Korean/English with English dominant | Korean must be primary |
| Korean text smaller than English | Korean readability requirement |
| Romanized Korean instead of Hangul | Hangul required |
| Technical English terms without Korean translation | Korean translation required |
IFU (Instructions for Use) Requirements
IFU Structure
Korean IFU must include:
- Device identification (mirror label elements)
- Intended use and indications
- Contraindications
- Warnings and precautions
- Adverse events that have occurred
- Operating instructions (step-by-step)
- Storage and handling
- Sterilization (if applicable)
- Maintenance and cleaning
- Disposal instructions
- Manufacturing date
- KLH contact for inquiries
IFU Format
- Korean primary language
- Bilingual acceptable (Korean + English) if Korean is primary
- Font size readable (typically 10+ point for body text)
- Clear hierarchy (sections, subsections)
- Icons supplemental to text (not replacing)
- Electronic IFU (eIFU) acceptable with Korean primary
Approved Warning Phrasings
MFDS maintains a list of approved Korean warning phrasings. Using these phrases reduces deficiency risk.
| English Concept | MFDS-Approved Korean |
|---|---|
| "Do not use after expiration date" | "사용기한이 지난 제품은 사용하지 마십시오" |
| "Single use only" | "1회용입니다. 재사용하지 마십시오" |
| "Sterile if package is unopened" | "포장이 개봉되지 않은 상태에서 멸균이 보장됩니다" |
| "Store at room temperature" | "실온(1-30°C)에서 보관하십시오" |
| "Consult IFU before use" | "사용 전 사용설명서를 반드시 읽어보십시오" |
| "Caution: Federal law restricts..." (FDA phrase) | Not used in Korea; remove |
Symbols and Pictograms
Korean medical device labels accept ISO 15223-1 symbols, with Korean text explanations required:
- 🇰🇷 KLH name and address: always Korean text
- 🌡️ Storage temperature: symbol + Korean range
- ⚠️ Warning symbol: with Korean warning text
- 💧 Sterilization: symbol + Korean confirmation
- 📅 Use-by date: symbol + Korean date format (YYYY.MM.DD)
Labeling Strategy by Device Class
Class I
- 14 mandatory elements
- Korean primary
- Bilingual acceptable
- Simpler IFU
Class II
- 14 mandatory elements
- Korean primary
- Comprehensive IFU
- Risk-specific warnings prominent
Class III/IV
- 14 mandatory elements
- Korean primary
- Detailed IFU with risk-benefit discussion
- Clinical context information
- Patient information leaflet (if applicable)
Common Labeling Compliance Failures
Failure 1: KMD Number Placeholder Not Updated
Pre-submission labels use placeholder; post-approval labels must use actual KMD number.
Risk: Inspector finding; potential product recall.
Fix: Label update workflow triggered by KMD number issuance.
Failure 2: KLH Information Outdated
KLH changes or KLH address changes without label updates.
Risk: Label not aligned with current MFDS record.
Fix: KLH change automatically triggers label review.
Failure 3: English-Only Labels in Korean Market
Manufacturer ships English-only labels assuming distributor adds Korean overlay.
Risk: Product cannot be sold legally; import detained.
Fix: Korean labels applied at manufacturing or before customs clearance.
Failure 4: Outdated Warning Phrasings
Old MFDS-approved warnings vs current preferred phrasings.
Risk: Inspector finding; not severe but flagged.
Fix: Periodic label review against current MFDS guidance.
Failure 5: Bilingual Labels with English Dominant
Korean text smaller or less prominent than English.
Risk: Inspector finding; Korean readability requirement.
Fix: Korean text equal or larger than English in label design.
Labeling Change Control
Label changes follow tiered classification:
| Label Change | Tier | Filing Required |
|---|---|---|
| KMD number addition (post-approval) | Tier 1 | Internal log |
| Korean warning phrasing update to current MFDS preferences | Tier 1 | Internal log |
| KLH name or address change | Tier 2 | Change notification |
| Warning addition (new safety information) | Tier 2-3 | Notification or re-registration |
| Indication change | Tier 3 | New registration |
Cost of Labeling Compliance
| Activity | Cost Range |
|---|---|
| Initial Korean label development | $5K–$15K |
| Korean IFU development | $5K–$20K |
| Bilingual label design | $3K–$10K |
| Translation of complex IFU | $10K–$30K |
| Pre-submission label review | $2K–$5K |
| Periodic label compliance audit | $3K–$8K/year |
Frequently Asked Questions
Q: Can we use stickers or overlays for Korean labels?
A: Acceptable for limited Korean text additions (KMD number, KLH info), but primary device label must be Korean from manufacturing. Heavy reliance on stickers raises inspector concerns.
Q: Do we need different labels for different Korean distributors?
A: No. KMD-based labels are universal across Korean distribution. KLH information is the regulatory contact, not the distributor.
Q: What about labels on small devices where text doesn't fit?
A: MFDS allows IFU reference for elements not fitting on small device labels. Minimum on-device label includes product identification and KMD number.
Q: Are electronic labels (e-labels) acceptable?
A: Electronic IFU (eIFU) acceptable for some device categories. Physical labels still required on device or package. Check MFDS Notice 2022-110 for current eIFU eligibility.
Q: How does Leanabl help with labeling?
A: Leanabl's Labeling Services handles Korean label and IFU development from MFDS requirements, not from translation of foreign labels.
How Leanabl Helps
- Labeling Services — Korean label and IFU development
- Lean IFU — streamlined multilingual IFU strategy
- Korea Medical Device Registration — registration with compliant labeling
Contact Leanabl for labeling scoping.
Last updated: 2026-05-15.
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