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