New Guidelines on addresses of manufacturing sites for KGMP

작성자 관리자 날짜 2023-06-16 09:57:55 조회수 120

The Ministry of Food and Drug Safety ("MFDS") in Korea released new 'Guidelines on addresses of KGMP manufacturing sites for medical devices' ("Guidelines")on June 2, 2023.  This new guidelines provides clear guidance on how to insert addresses as well as the format for KGMP certification application of manufacturing sites of medical devices.  As a reference, the addresses inserted in the application for KGMP certification will also be reflected in the certifications itself and only the addresses that have been included in the certification will permitted to export medical devices to the Korean market.  If a product that is manufactured from a non-KGMP certified manufacturing site is imported into Korea, the importer of the medical device can be liable for administrative and criminal sanctions such as business suspension and/or prison term/criminal fines. Please find attached our newsletter.