STED Submission Templates
MFDS provides template documents for 품목허가 and 품목신고 applications to help applicants structure their submissions correctly.
Available templates (from MFDS eSubmission portal)
- STED outline template (Word format) — per IMDRF STED structure
- Application forms for 품목허가
- Application forms for 품목신고
- KGMP self-assessment checklist
- Adverse event report form
- Change application forms (변경허가 / 변경신고)
Where to access
Templates available at:
- MFDS eSubmission portal: emed.mfds.go.kr → download section
- MFDS website: mfds.go.kr → legal/regulatory resources