KGMP Process introduction

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DefinitionGMP 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 KGMPKGMP 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 InstituteTypes 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 PartyClassification

Types of GMP Inspection

Initial

AdditionalChangeRecertification1

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 & GuidanceStandards for manufacturing and quality management of medical devices(similar to ISO 13485)GMP marking