OSUNG MND
Gimpo, South Korea
Gimpo-based dental instrument company offering diagnostic, periodontal, surgical, implant, restorative and endodontic hand instruments.
Taewoong Medical
Gimpo, South Korea
Gimpo manufacturer of stents and RF ablation devices, exporting through exclusive distributors in each country.
Business types in Gimpo
Regulation in South Korea
Korea classes devices 1–4: Class 1 notification, Class 2 certification (some approval), Class 3–4 MFDS approval, plus manufacturing or import business licences and GMP.
From the sourced MFDS entry, checked 29 October 2026. General information, not legal advice. Requirements for South Korea · All medical certifications
Frequently asked questions
How does a foreign manufacturer get devices into the Korean market?
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.
What should I ask a Korean manufacturer before importing its devices?
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.