Technical Documentation β Overview
Technical documentation (κΈ°μ λ¬Έμ) follows the IMDRF STED format, adapted for Korean-specific requirements. Required for all νλͺ©νκ° and νλͺ©μ κ³ .
STED sectionsβ
| # | 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 additionsβ
- Test reports from MFDS-recognised testing labs (IEC 60601 series, ISO 10993, KS standards)
- Korean-language labelling draft Β· Biocompatibility (ISO 10993) Β· Sterilisation validation
STED submission format and version control β The STED submitted to MFDS must include: β β’ Document version number and date β’ Table of contents with section numbering β’ Revision history documenting all changes from previous versions β’ Cross-references between sections β’ Index of referenced standards and test reports β’ Korean-language executive summary (1β2 pages) β Electronic submission via the MFDS portal requires PDF format with searchable text. Large documents (>50 MB) should be divided into logical sections for review.