Certification Scope and Grading
Certification scope
The KGMP certificate specifies the manufacturing site and the categories of devices covered. Common scope categories:
- Active medical devices (electrical/electronic)
- Passive medical devices (non-powered)
- Sterile devices
- IVD devices (separate chapter under IVD Act)
- Implantable devices
Adding new product categories
A scope extension application is required to add a new device category. MFDS determines whether a new inspection or document review is sufficient.
Alignment with 품목허가
The device applied for in a 품목허가 must fall within the scope of the manufacturer's KGMP certificate. If not, scope extension must be completed first.