The Korean Food and Drug Administration (KFDA), South Korea’s medical device market regulator, has eased some of its Korea Good Manufacturing Practice (KGMP) quality system requirements (in Korean only) for medical device manufacturers in order to streamline its inspection process, Emergo Group’s Seoul office has learned.
In some instances going forward, onsite KGMP quality management system audits of foreign manufacturers will be conducted only by third-party inspectors, whereas previously such inspections were carried out by both third-party and KFDA personnel. The revised KFDA regulations will have the following specific effects:
For Class II medical devices sold in South Korea:
For Class III medical devices in South Korea:
Waived KGMP quality system inspection requirements
For some medical devices, the KFDA has waived onsite audit requirements outright. Class I devices (including Class I special control devices) qualify for the new onsite audit waiver, as well as manufacturers seeking to add a new device category. Companies seeking to change manufacturing locations are also exempt from audit requirements, but must submit home-country quality system certification and a report from another quality system inspection agency to the KFDA.
In addition, importers representing several foreign manufacturers must have only one of those manufacturers undergo onsite audits; previously, all manufacturing sites under an importer’s representation would have to be inspected for Korean GMP compliance.
In instances where several entities such as contract manufacturers are involved in producing a medical device, the KFDA will require KGMP auditing for only one of the entities involved in production of that medical device.
Bottom line: Less onerous KGMP quality system requirements for foreign medical device manufacturers and importers will not only lower barriers to market entry in South Korea but also free up KFDA regulatory resources and potentially reduce device review timeframes.