11.09.12
New KGMP Certification for Foreign Manufacturers
The KFDA established a new Korea Good Manufacturing Practice Certificate for foreign medical device manufacturers. A KGMP Certificate is required for all foreign manufacturers of Class II, III, and IV medical devices. Class I device manufacturers are exempt from this requirement.
Current manufacturers who already had their products approved by the KFDA before April 8, 2012, will be granted a KGMP Certificate automatically. The KGMP Certificate for these manufacturers will be valid through the remaining period of the Korea Good Import Practice Certification that the importer holds. However, a new KGMP Certificate may be required if these current manufacturers register new products in a new category or register a new manufacturing site.
In order to apply for a KGMP Certificate, a local importer will need to submit the application on behalf of the foreign medical device manufacturer. After receiving the application materials, the KFDA will then determine whether to conduct an on-site inspection or conduct only a document review. Currently, the KFDA plans to perform approximately 20 to 30 on-site inspections per year, and will approve most other KGMP Certification applications through a document review only.
The KFDA established a new Korea Good Manufacturing Practice Certificate for foreign medical device manufacturers. A KGMP Certificate is required for all foreign manufacturers of Class II, III, and IV medical devices. Class I device manufacturers are exempt from this requirement.
Current manufacturers who already had their products approved by the KFDA before April 8, 2012, will be granted a KGMP Certificate automatically. The KGMP Certificate for these manufacturers will be valid through the remaining period of the Korea Good Import Practice Certification that the importer holds. However, a new KGMP Certificate may be required if these current manufacturers register new products in a new category or register a new manufacturing site.
In order to apply for a KGMP Certificate, a local importer will need to submit the application on behalf of the foreign medical device manufacturer. After receiving the application materials, the KFDA will then determine whether to conduct an on-site inspection or conduct only a document review. Currently, the KFDA plans to perform approximately 20 to 30 on-site inspections per year, and will approve most other KGMP Certification applications through a document review only.