Application and KGMP Certification Process
Step-by-step process
1. Establish a QMS compliant with KGMP / ISO 13485
2. Conduct internal audits and management review
3. Submit KGMP certification application via MFDS eSubmission portal
4. MFDS schedules on-site inspection
5. MFDS on-site inspection conducted
6. Correct any nonconformities identified (CAPA)
7. MFDS issues KGMP certificate
8. Manufacturer may now apply for 품목허가 / 품목신고
Application requirements
- Quality manual
- List of devices to be manufactured (scope)
- Organisational chart and responsible persons
- Facility layout plan
- Equipment list
- Quality procedures summary
Scope of certification
The KGMP certificate specifies the manufacturing site and the categories of devices covered. Each additional product category may require scope extension.