Enforcement Rules (시행규칙)
The Enforcement Rules (시행규칙) are issued by the MFDS Minister and contain the most detailed procedural and technical requirements — including application forms, documentation checklists, and procedural timelines.
Key topics
- Application forms for 품목허가 and 품목신고
- Documentation requirements per application type
- GMP inspection procedures and checklists
- Adverse event reporting forms and procedures
- Labelling minimum content requirements
- Re-examination and re-evaluation procedures
- Manufacturer and importer licensing details
Practical importance
The Enforcement Rules are the most directly actionable legislative instrument for regulatory submissions — they specify exactly what to submit and in what format.
Official source
law.go.kr — search: 의료기기법 시행규칙