Technical Documentation — Overview
Technical documentation (기술 문서) follows the IMDRF STED format, adapted for Korean-specific requirements. Required for all 품목허가 and 품목신고.
STED sections
| # | Section | Grades |
|---|---|---|
| 1 | Device description and specifications | All |
| 2 | Reference to similar/predicate devices | When applicable |
| 3 | Design and manufacturing information | All |
| 4 | Safety and performance requirements | All |
| 5 | Risk management (ISO 14971) | All |
| 6 | Product verification and validation | All |
| 7 | Clinical/performance evaluation | III/IV; IVD C/D |
| 8 | Post-market information | III/IV |
Korean-specific additions
- Test reports from MFDS-recognised testing labs (IEC 60601 series, ISO 10993, KS standards)
- Korean-language labelling draft · Biocompatibility (ISO 10993) · Sterilisation validation
STED submission format and version control The STED submitted to MFDS must include: • Document version number and date • Table of contents with section numbering • Revision history documenting all changes from previous versions • Cross-references between sections • Index of referenced standards and test reports • Korean-language executive summary (1–2 pages) Electronic submission via the MFDS portal requires PDF format with searchable text. Large documents (>50 MB) should be divided into logical sections for review.
STED language and submission requirements
The STED submitted to MFDS must be prepared in English as the primary language, with critical sections (Device Description, Intended Use, Risk Management Summary, Conclusions) provided in Korean translation. Non-clinical technical sections (e.g., detailed engineering drawings, raw test data) may be submitted in English provided they are referenced and cross-indexed in the Korean sections. All regulatory claims, contraindications, warnings, and post-market surveillance plans must include official Korean translations. If the STED exceeds 50 MB, the submission should be divided into logical volumes (e.g., Volume 1: Device Description and Design; Volume 2: Testing and Validation; Volume 3: Clinical/Performance Data). Each volume must include a complete table of contents and cross-references to maintain document integrity during MFDS review.