BIOTEM
Hanam, South Korea
Hanam, Gyeonggi dental implant company emphasising global-level manufacturing quality.
CG MedTech (formerly U&I Corporation)
Uijeongbu, South Korea
Korean developer and manufacturer of spinal and orthopaedic implant devices.
CORENTEC
Cheonan, South Korea
Cheonan-based maker of artificial hip, knee and shoulder joints and spinal fixation devices, founded in 2000 with its own R&D centre and plant.
Dentium
South Korea
Korean dental implant maker using automated manufacturing, active since 2000 with a global dealer network.
DiaDent Group International
Cheongju, South Korea
Korean manufacturer and exporter of endodontic products, dental instruments and small equipment since 1985.
DIO Implant
Busan, South Korea
Busan-based dental implant company offering implant systems and digital guided implant solutions.
DynaMedic
Cheongju, South Korea
Osong, Cheongju developer of surgical power tool systems for human and veterinary use.
FINEMEDIX
Daegu, South Korea
Daegu manufacturer of endoscopic accessories developed with clinicians, preparing CE and FDA exports.
GBS Commonwealth
Seoul, South Korea
Seoul company founded in 2016 developing, manufacturing and distributing spinal implants and instruments.
GENOSS
Suwon, South Korea
Suwon medical device maker producing balloon catheters and 3D-printed spinal cages.
IBS Implant
Daejeon, South Korea
Korean minimally invasive dental implant company that received a US$3 million export award.
Jeil Medical
Seoul, South Korea
Seoul manufacturer of maxillofacial, trauma and orthognathic plate and screw systems, holding a Korean medical device manufacturing licence.
LIVSMED
Seongnam, South Korea
Korean medical device company established in 2011 manufacturing articulating laparoscopic instruments.
M.I.Tech
Pyeongtaek, South Korea
Korean developer and manufacturer of self-expandable metallic stents and endoscopic devices since 1991.
MANTIZ
Daegu, South Korea
Daegu spinal implant company founded in 2015 that develops and manufactures its products in Korea.
Mediana
Wonju, South Korea
Korean medical device maker of patient monitoring, emergency care and body composition solutions, with HQ, factory and R&D in Wonju.
Mediclus
Cheongju, South Korea
Cheongju dental company established in 2011 that exports dental burs and surgical kits.
Medyssey
Jecheon, South Korea
South Korean company founded in 2003 that designs, develops and manufactures spine implant systems and trauma fixation products in Jecheon.
MegaGen Implant
Daegu, South Korea
Daegu dental implant manufacturer with its headquarters and factory in Dalseong-gun and a global distributor network.
META BIOMED
Cheongju, South Korea
Cheongju producer of endodontic products, bio-absorbable sutures and bone graft materials, with plants in China and Vietnam.
Neobiotech
Wonju, South Korea
Korean dental implant manufacturer headquartered in Wonju, recipient of a US$10 million export award.
OSUNG MND
Gimpo, South Korea
Gimpo-based dental instrument company offering diagnostic, periodontal, surgical, implant, restorative and endodontic hand instruments.
Saeshin Precision
Daegu, South Korea
Daegu manufacturer of dental handpieces and micromotors that also offers TRAUS surgical power systems for spine, ENT and maxillofacial use.
ScienceMedic
Anyang, South Korea
Korean maker of orthopaedic power tools, saws and burs for bone cutting, exporting to 30 countries.
Business types in South Korea
Cities in South Korea
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.