Enforcement Decree (시행령)
The Enforcement Decree (시행령) is issued by the Korean Cabinet and provides detailed procedural provisions not contained in the primary Act.
Key topics
- Specific application fee amounts for 품목허가 and GMP certification
- Composition and operation of MFDS advisory committees
- Criteria for MFDS designation of recognised testing laboratories
- Delegation of MFDS inspection authority
- Transitional provisions for new requirements
Official source
law.go.kr — search: 의료기기법 시행령