How to Prepare a Korean STED Technical File in 8 Weeks
A week-by-week framework for converting existing CE Mark or FDA 510(k) technical documentation into MFDS-compliant Korean STED format.
What Is Korean STED?
Korean STED differs from international STED variants in three ways:
- Mandatory Korean-language Risk Management Plan referencing ISO 14971:2019
- Korean Medical Device Standard (식약처 고시) mapping for performance testing
- Korean labeling and IFU drafts (not final, but submission-ready)
The 8-Section Structure
| Section | Content | Source from CE/FDA |
|---|---|---|
| 1 | Device Description and Intended Use | CE Annex II Section 2, FDA 510(k) Section 5 |
| 2 | Classification and Reference Standards | New (Korea-specific) |
| 3 | Risk Management Summary | ISO 14971 risk file (adapted) |
| 4 | Design and Manufacturing Process | CE Annex II Section 4 |
| 5 | Performance Testing | CE test reports, FDA 510(k) Section 14 |
| 6 | Clinical Evaluation | CE CER (adapted) |
| 7 | Labeling and IFU (Korean) | New (translated + reformatted) |
| 8 | Post-Market Surveillance Plan | EU MDR PMS plan (adapted) |
8-Week Preparation Framework
Week 1: Source File Audit
Goal: Inventory existing CE/FDA documentation and identify gaps.
- Map existing CE Annex II or FDA 510(k) sections to Korean STED 8-section structure
- Identify sections that require new content (Section 2, Section 7)
- Identify sections that require Korea-specific adaptation (Section 3, Section 6)
- Identify sections that can be largely reused with reformatting (Sections 1, 4, 5)
- Confirm KGMP certificate status (or initiate parallel KGMP application)
Output: Gap analysis report and preparation roadmap.
Weeks 2–3: Foundation Sections (1, 2, 4)
Goal: Build sections with the highest reuse from CE/FDA files.
- Section 1 (Device Description): Reformat existing description to MFDS structure. Add Korean device classification code per Medical Device Classification Code (의료기기 분류번호).
- Section 2 (Classification): New content. Map device to Korean Medical Device Standard codes and reference Korean Medical Device Law clauses applied.
- Section 4 (Design and Manufacturing): Translate CE Annex II Section 4. Add KGMP certificate reference (or note "pending inspection") and manufacturing site address in Korean.
Output: Sections 1, 2, 4 draft (Korean + English).
Weeks 3–4: Risk Management Section (3)
Goal: Adapt ISO 14971 risk management for Korean format.
- Reformat existing ISO 14971 Risk Management File to MFDS preferred summary template (typically 15–25 pages, not 100+)
- Map risks to Korean Medical Device Law Article 12 (Risk Management Requirements)
- Include Korean-language risk control summary table
- Reference benefit-risk justification in Korean
Critical: Korean STED Section 3 is a summary, not the full Risk Management File. The full file is retained for post-market obligations.
Output: Section 3 draft.
Weeks 4–5: Performance Testing (5)
Goal: Repackage existing IEC/ISO test reports for Korean review.
- Reformat test report cover pages to Korean format
- Map each test to Korean Medical Device Standard (식약처 고시) code
- Translate test conclusions and discussion (not raw data) to Korean
- Cross-reference Korea-recognized testing laboratories where reports were issued
Output: Section 5 draft with test report appendices.
Weeks 5–6: Clinical Evaluation (6)
Goal: Adapt CE Clinical Evaluation Report for Korean context.
- Translate CER core content (literature review, equivalence analysis, post-market data)
- Add Korea-specific section (2–3 pages):
- Korean patient population relevance
- Comparison with devices already approved in Korea (MFDS KMD database lookup)
- Korean clinical literature search (if applicable)
- Translate clinical conclusions to Korean
Output: Section 6 draft.
Weeks 6–7: Labeling and IFU (7)
Goal: Build Korean labeling from MFDS requirements (not from CE translation).
- Reference MFDS Notice 2022-110 (의료기기 표시·기재 가이드라인) for required Korean elements
- Draft Korean device label (mockup, since MFDS license number is post-approval)
- Translate IFU using MFDS-approved warning phrasings (not direct CE translation)
- Include Korean storage conditions in Celsius
- KLH name and Korean address as required label element
Output: Section 7 draft with label mockups and Korean IFU.
Week 7: Post-Market Surveillance (8)
Goal: Adapt EU MDR PMS plan to Korean vigilance reporting requirements.
- Translate PMS plan structure
- Map adverse event reporting requirements to Korean Medical Device Law:
- Serious adverse events: 15 days
- Fatalities: 5 days
- Other reportable events: 30 days
- Reference Korean post-market obligations under KLH responsibility
Output: Section 8 draft.
Week 8: Integration, Review, and Submission Prep
Goal: Final integration and quality review.
- Internal review of all 8 sections
- Cross-reference consistency check (device description across all sections)
- Korean language QA by native speaker familiar with regulatory terminology
- Pre-submission readiness check against the 5 most common deficiency categories
- KLH coordination for filing logistics
Output: Submission-ready Korean STED.
Critical Path Bottlenecks
In 12 foreign manufacturer projects, the typical delays occurred in:
| Bottleneck | Frequency | Mitigation |
|---|---|---|
| Korean clinical evidence adaptation (Section 6) | 10/12 | Start in Week 2, not Week 5 |
| Risk Management Summary translation (Section 3) | 8/12 | Use prior Korean translation if available |
| KGMP scheduling | 7/12 | Initiate in Week 1 — not after submission |
| Korean IFU phrasing | 6/12 | Draft from MFDS templates, not CE translation |
| KLH agreement and documentation | 4/12 | Resolve in Week 1 |
When 8 Weeks Is Not Enough
The 8-week framework assumes:
- Complete CE Mark or FDA 510(k) technical file available
- ISO 13485 / KGMP-aligned QMS in place
- KLH agreement executed before Week 1
- Native Korean regulatory writer assigned
If any of these are missing, add 2–4 weeks for prerequisite work.
Frequently Asked Questions
Q: Can we use a translation agency for Korean STED?
A: For raw translation of test reports and CE content, yes. For Sections 3, 6, and 7, you need a regulatory-trained Korean writer who understands MFDS terminology. Translation-only approaches generate deficiency notices about 70% of the time.
Q: How long is a typical Korean STED?
A: 150–400 pages depending on device complexity. Most of the length comes from performance testing reports (appendices), not narrative text. The narrative typically runs 60–120 pages.
Q: Do we submit in Korean or English?
A: Sections 1, 2, 4, 5 can be primarily English with Korean executive summaries. Sections 3, 6, 7, 8 must be primarily Korean. Final filing language is Korean for all regulatory-binding content.
Q: When should we initiate KGMP?
A: Week 1 of STED preparation. KGMP inspection takes 4–6 months to schedule, so it must run in parallel. Filing STED without KGMP results in conditional approval, adding 4–6 months to market entry.
Q: Can Leanabl prepare our Korean STED?
A: Yes. Leanabl's Technical Documentation & Registration service handles STED authoring end-to-end. We typically deliver in 6–8 weeks for well-prepared CE/FDA files.
How Leanabl Helps
- Korea Medical Device Registration — full MFDS registration program
- Technical Documentation & Registration — STED authoring
- Technical File Gap Analysis — pre-STED readiness assessment
- KGMP Certification — parallel KGMP for foreign sites
Contact Leanabl to scope your Korean STED project.
Last updated: 2026-05-15.
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