Updated 22 October 2026
Medical device distributors in South Korea: 862 licensed establishments
The Bastion Hale Distributor Index lists 862 medical device establishments registered with an address in South Korea: 18 with a channel role (importer, distributor, wholesaler or authorised representative), 85 registration holders without a channel role, and 759 registered as manufacturer or exporter only. The records come from US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
By segment
Segments come from the device listings linked to each establishment, so one company can appear in several rows. Imaging and radiology are shown because the registries contain them; Bastion Hale's launch services do not cover them.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 18 | 2% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 89 | 10% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 842 | 98% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 90 | 10% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in South Korea
In South Korea the MFDS approval is held by a Korea Licence Holder, which is usually the importer. Changing importer means transferring or re-filing the approval, so many manufacturers appoint an independent holder.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later; the Audit covers it per market.
Top 20 establishments by size
Channel roles (importer, distributor, wholesaler, authorised representative) are listed first, then registration holders, then manufacturers. Size is a 0 to 100 score built from products listed, registrations held, roles, sources and principals represented. Complete is 0 to 5 for website, address, segments, principals and counts.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | OSSTEM IMPLANT CO., LTD. Haeundae-gu Busan, GD | Channel Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Dental, Ear, nose and throat +3 more | 358 | 41 | 0 | 65.6 | 3/5 |
| 2 | DIADENT GROUP INTERNATIONAL CHONGJU CITY Chungbuk | Channel Distributor, Registration holder, Manufacturer, Exporter | General hospital and consumables, Dental, Ophthalmic | 143 | 34 | 0 | 60.1 | 3/5 |
| 3 | META BIOMED CO., LTD. Cheongju-si Chungbuk | Channel Distributor, Registration holder, Manufacturer | General hospital and consumables, Dental, Surgery and endoscopy | 34 | 15 | 0 | 48.0 | 3/5 |
| 4 | B&L BIOTECH CO., INC Ansan City Gyeonggi, Gyeonggi-Do | Channel Distributor, Manufacturer | Dental | 33 | 2 | 0 | 38.4 | 3/5 |
| 5 | SUGENTECH, INC. Cheongju-si Chungbuk | Channel Distributor, Registration holder, Manufacturer | In-vitro diagnostics | 4 | 2 | 0 | 30.3 | 3/5 |
| 6 | SMILELAB CO., LTD. Seongnam-si Gyeonggi | Channel Distributor, Manufacturer, Exporter | In-vitro diagnostics | 2 | 1 | 0 | 22.4 | 3/5 |
| 7 | Dongkook Pharmaceutical Co., Ltd. Seoul | Channel Distributor, Manufacturer | Patient monitoring and neurology, Surgery and endoscopy | 3 | 1 | 0 | 22.2 | 3/5 |
| 8 | SOOSUNG MEDICAL Seoul | Channel Distributor, Manufacturer | General hospital and consumables, Surgery and endoscopy | 3 | 1 | 0 | 22.2 | 3/5 |
| 9 | DONG-A PHARMACEUTICAL CO., LTD. Seoul | Channel Distributor | Gastroenterology, urology and OB/GYN, Surgery and endoscopy | 5 | 1 | 0 | 22.0 | 3/5 |
| 10 | JBP KOREA CO.,LTD. Gangnam-gu Seoul | Channel Distributor | General hospital and consumables, Surgery and endoscopy | 4 | 1 | 0 | 21.1 | 3/5 |
| 11 | APR Co., Ltd. Seoul | Channel Distributor, Manufacturer | Patient monitoring and neurology, Surgery and endoscopy | 2 | 1 | 0 | 20.8 | 3/5 |
| 12 | HANKOOK LATEX GONGUP CO., LTD. CHUNCHEON-SI Gangwon | Channel Distributor, Manufacturer | Gastroenterology, urology and OB/GYN | 2 | 1 | 0 | 20.8 | 3/5 |
| 13 | Cell Bio Human Tech Co.,Ltd Hwaseong Gyeonggi | Channel Distributor, Manufacturer, Exporter | Surgery and endoscopy | 1 | 1 | 0 | 20.3 | 3/5 |
| 14 | SPOL CO., LTD. Namdong-gu Incheon | Channel Distributor, Manufacturer, Exporter | General hospital and consumables | 1 | 1 | 0 | 20.3 | 3/5 |
| 15 | HERITAGE VENTURES CO., LTD. Seoul | Channel Distributor, Exporter | Gastroenterology, urology and OB/GYN | 1 | 1 | 0 | 18.7 | 3/5 |
| 16 | JION MEDITECH CO.LTD Anyang-si Gyeonggi | Channel Distributor, Manufacturer | Patient monitoring and neurology | 1 | 1 | 0 | 18.7 | 3/5 |
| 17 | MAXI EYE Daegu Gyeongbuk | Channel Distributor, Manufacturer | Ophthalmic | 1 | 1 | 0 | 18.7 | 3/5 |
| 18 | PLANDOCS INC. Seoul | Channel Distributor, Exporter | Surgery and endoscopy | 1 | 1 | 0 | 18.7 | 3/5 |
| 19 | Megagen Implant Co., Ltd. Daegu | Holder Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Dental, Orthopaedics, spine and trauma +2 more | 233 | 25 | 0 | 59.9 | 3/5 |
| 20 | DIO Corporation Haeundae-gu Busan | Holder Registration holder, Manufacturer, Exporter | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +2 more | 202 | 27 | 0 | 59.6 | 3/5 |
Questions about medical device distributors in South Korea
How many medical device distributors are there in South Korea?
The Index counts 862 medical device establishments registered in South Korea, of which 18 hold a channel role as importer, distributor, wholesaler or authorised representative. The rest are registration holders or manufacturers. The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a medical device registration in South Korea?
In South Korea the MFDS approval is held by a Korea Licence Holder, which is usually the importer. Changing importer means transferring or re-filing the approval, so many manufacturers appoint an independent holder.
How do I find a medical device distributor in South Korea?
Start with the segment table on this page, open the top establishments and check their roles, principals and registration counts. Then search the Index for your device and South Korea to see the counts for your segment and reveal three profiles. For a shortlist with our read on each name, book the International Launch Audit.
What does the Distributor Index count as a distributor in South Korea?
An establishment is a company that appears in a public regulatory registry with an address in South Korea, in any of the roles importer, distributor, wholesaler, authorised representative, sponsor, registration holder, manufacturer or exporter. Each company is counted once per country even if it holds several licences or appears in several registries. No contacts or named individuals are collected.
Segment pages for South Korea
Related markets in Asia Pacific
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 857 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 93 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.