Application Contents and STED Requirements
A 품목허가 application follows the IMDRF STED (Summary Technical Documentation) format with Korean-specific additions.
STED sections
| # | Section | Required for |
|---|---|---|
| 1 | Device description and specifications | All grades |
| 2 | Reference to similar / predicate devices | When applicable |
| 3 | Design and manufacturing information | All grades |
| 4 | Safety and performance requirements | All grades |
| 5 | Risk management (ISO 14971) | All grades |
| 6 | Product verification and validation | All grades |
| 7 | Clinical evaluation / performance evaluation | Grade III/IV; IVD C/D |
| 8 | Post-market information | Grade III/IV |
Korean-specific additions
- Test reports from MFDS-recognised testing laboratories (IEC 60601-1 series, ISO 10993, etc.)
- Korean-language labelling draft
- Biocompatibility assessment (ISO 10993 series)
- Sterilisation validation (for sterile devices)
- Clinical trial approval documents (if Korean trial conducted)