GLGlossary
KGMP (manufacturing and quality management standard).
A standard for verifying a manufacturing site's quality management system so that medical devices are made to a consistent quality.
It looks at whether the facility and management system that make the product meet the standard, rather than the product itself. Whether it applies and how it is reviewed can vary depending on the product's class. For overseas manufacturing sites, the manufacturer's cooperation may be needed for preparation and scheduling.
Related work & timing
This proceeds together with approval or certification for Class 2 and above, and is divided into manufacturing KGMP and import GMP (document review / on-site inspection). We can handle the document preparation and manage the review process on your behalf.
Basis
- Regulation on Manufacturing and Quality Control Standards for Medical Devices (MFDS Notification)
- Medical Devices ActView source →
The references shown are for guidance; confirm the exact, current requirements against the source text and through consultation.
The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.