By Stewart Eisenhart, Emergo Group
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, on-site 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:
- In most cases, Class II device manufacturers’ sites will be subject solely to third-party audits, after which third-party inspectors will provide reports to the KFDA for final decision.
- For Class II devices using novel technologies or that have no predicate devices, both KFDA and third-party personnel will perform on-site inspections.
- Manufacturers that have had KGMP non-compliance issues within three years or that have reported any safety or efficacy problems prior to an inspection will also undergo inspections by both KFDA and third-party inspectors.
- On-site audits for KGMP renewals have been waived by the KFDA.
For Class III medical devices in South Korea:
- KGMP renewal inspections for Class III devices will be carried out solely by third-party auditors, who will then report findings to the KFDA for final decision.
- Any KGMP non-compliance issues in the previous three years will require a joint third-party and KFDA audit.
- Any safety and/or efficacy issues reported will also require a joint KFDA/third-party audit of a manufacturing site.
Waived KGMP quality system inspection requirements
For some medical devices, the KFDA has waived on-site audit requirements outright. Class I devices (including Class I special control devices) qualify for the new on-site 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 on-site 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 time frames.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
