Definition
- GMP is an abbreviation of“Good Manufacturing Practice” and it means Quality Management System of Medical Device for ensuring that products are consistently produced and controlled according to quality standards.
Procedure
What is KGMP
- KGMP is an abbreviation of “Korea Good Manufacturing Practice” and it means Quality Management System of Medical Device for ensuring that products are consistently produced and controlled according to MFDS quality management standard which is similar to ISO13485. Every three years, MFDS requires recertification in order for it to be valid.
- The process of KGMP certification requires effort but it will not be cumbersome if you have support of local professionals.
MDWorks Korea provides the total KGMP compliance package service includes interaction with Korean authorities and support for desk and on-site inspections with the expertise.
KGMP Application Dossier
- ∙ Import Business Licenses
- ∙ Quality Manual
- ∙ DMR or DMF
- ∙ Controlled documents or records required by MFDS regulations.
3rd Party Agency
- ∙ Korea Conformity Laboratories
- ∙ Korea Testing Certification
- ∙ Korea Testing Laboratory
- ∙ Korea Testing & Research Institute
Types of GMP Inspection
- ∙ The GMP Inspection falls into one of types listed below by a level of product class and classification.
- ∙ Single Inspection - 3rd Party
- ∙ Joint Inspection – MFDS regional office + 3rd Party
| Classification | Types of GMP Inspection | |||
|---|---|---|---|---|
| Initial | Additional | Change | Recertification1 | |
| Class I | Exemption | |||
| Class II | Single-Onsite | Single-Desk | Single-Desk | Single-Onsite |
| Class III | Joint-Onsite | Joint-Desk | Joint-Desk | Single-Onsite2 |
| Class IV | Joint-Onsite | Joint-Desk | Joint-Desk | Joint-Onsite |
1Recertification for Class III Medical Device is principally subject to Single-Onsite Inspection, but MFDS could require to conduct Joint-Onsite Inspection if a foreign manufacturer has been reported with any non-conformities and safety concerning risks for the last three years.
Recertification should be planned three months prior to the date that the certificate should be verified.
Regulations & Guidance
- Standards for manufacturing and quality management of medical devices(similar to ISO 13485)
GMP marking
