Surgical Instruments Manufacturers in South Korea

Through a Korean company holding an MFDS import business license. Foreign manufacturers supply through a licensed Korean importer, and for imported devices the importer applies for the product notification, certification or approval. The import business license comes from the regional MFDS office and is processed together with the first product license; it is issued once that product license is approved.

The importer needs a qualified quality manager, must meet GMP (KGMP) requirements, and keeps records of import quantities and sales for tracked devices. Third-party sources describe a "Korea License Holder" model; MFDS describes this through the importer license. See the medical certifications page.

Medical certifications

MFDS licenses (manufacturing business license, product notification, certification or approval, KGMP certificate) show the device's status in Korea, not elsewhere. Ask a Korean supplier for:

• its MFDS manufacturing business license and the product license for the exact model;
• evidence for your own market, such as CE marking with a notified body certificate, FDA registration and listing, or local registration through your importer;
• its ISO 13485 or MDSAP certificate, and labeling in your required language.

Listed Korean companies are in cities such as Daegu, Cheongju, Seoul, Gimpo and Wonju. See the South Korea country page.

South Korea