Market authorisation in Korea through a Korea License Holder.
Notification, certification or approval by class, KGMP certification and the responsibilities of your local licence holder.
Key facts
Pathways
- Class 1: notification
- Class 2: certification, largely through MFDS-designated review bodies
- Class 3 and 4: approval by MFDS
- Clinical trial approval where Korean clinical data are required
What you will need
- Technical documents and test reports
- Clinical data for higher-risk and novel devices
- Korean labelling
- KGMP certificate
Sequence and decision points
- 01ClassifyConfirm the class and product category.
- 02Appoint a KLHKorean importer or licence holder.
- 03KGMPCertification of the QMS and manufacturing sites.
- 04SubmitNotification, certification or approval application.
- 05Licence and monitorMarket entry, then post-market duties.
Korea Good Manufacturing Practice (KGMP) certification, aligned with ISO 13485, including audits of foreign manufacturing sites.
Foreign manufacturers act through a Korea License Holder (KLH), usually the importer, which holds the licence.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
MFDS publishes processing periods by application type. Plan KGMP certification in parallel with the product application.
After market entry
- Adverse event reporting to MFDS
- Tracking management for designated implantable devices
- UDI requirements
- KGMP renewal
How we help
- Classification and pathway strategy
- KGMP readiness
- Technical document preparation support
- KLH coordination
- Post-market reporting
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about South Korea
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Is ISO 13485 or MDSAP enough for KGMP?
No. KGMP is a separate certification, although an ISO 13485-aligned system makes it much easier to obtain.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.