Updated 22 October 2026
Orthopaedic and spine device distributors in Japan: 34 licensed establishments
The Bastion Hale Distributor Index lists 34 establishments in Japan whose registry records include orthopaedics, spine and trauma: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 0 manufacturers' own import or sales entities, 0 regulatory representatives, and 34 manufacturers or exporters, out of 568 medical device establishments in Japan overall. The records come from US FDA (openFDA), Health Canada and MHRA UK, last seen on 23 October 2026.
Orthopaedics covers implants for joints, spine and trauma, together with instruments and bone substitutes. Implants are usually Class IIb or III, so the importer or registration holder carries real regulatory work and hospitals often buy through tenders. Distributors in this segment tend to employ clinical support staff who attend surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Registration holder | 11 | 32% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 31 | 91% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 7 | 21% | 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 Japan
In Japan the marketing approval or certification is held by a Marketing Authorisation Holder (MAH) based in Japan, or by a Designated MAH acting for a foreign manufacturer. The foreign manufacturer registers separately with PMDA. An independent D-MAH keeps the approval out of the distributor's hands.
Top 0 independent orthopaedics, spine and trauma distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
No independent distributor is registered here yet; every establishment on record is a manufacturer or a manufacturer's own sales entity.
Include manufacturers, their own sales entities and regulatory representatives (34)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS MEDICAL SYSTEMS CORP. HACHIOJI-SHI Tokyo, Hachioji-shi | Manufacturer Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 351 | 229 | 0 | 74.0 | 3/5 |
| 2 | CANON INC. Kawasaki Kanagawa | Manufacturer Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 673 | 129 | 0 | 73.7 | 3/5 |
| 3 | FUJIFILM CORPORATION ASHIGARAKAMI-GUN Kanagawa | Manufacturer Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +4 more | 163 | 87 | 0 | 64.7 | 3/5 |
| 4 | NAKANISHI INC. Kanuma Tochigi | Manufacturer Registration holder, Manufacturer | Dental, Ear, nose and throat, Patient monitoring and neurology +2 more | 411 | 70 | 0 | 65.9 | 3/5 |
| 5 | NIDEK CO., LTD. Gamagori | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics, Ophthalmic, Orthopaedics, spine and trauma +1 more | 113 | 57 | 0 | 58.5 | 3/5 |
| 6 | KURARAY NORITAKE DENTAL INC. Kurashiki | Manufacturer Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +2 more | 258 | 50 | 0 | 58.6 | 3/5 |
| 7 | NIHON KOHDEN CORPORATION SHINJUKU-KU Tokyo, Tokyo | Manufacturer Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 92 | 33 | 0 | 57.3 | 3/5 |
| 8 | ITO COMPANY LIMITED Kawaguchi Saitama | Manufacturer Registration holder, Manufacturer, Exporter | Patient monitoring and neurology, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 68 | 17 | 0 | 52.0 | 3/5 |
| 9 | TSK LABORATORY, JAPAN TOCHIGI-SHI, Tochigi-Ken | Manufacturer Registration holder, Manufacturer | General hospital and consumables, Orthopaedics, spine and trauma, Surgery and endoscopy | 10 | 9 | 0 | 40.7 | 3/5 |
| 10 | INAMI & CO., LTD. Bunkyo Tokyo | Manufacturer Manufacturer | General hospital and consumables, In-vitro diagnostics, Ophthalmic +2 more | 32 | 3 | 0 | 37.3 | 3/5 |
| 11 | SEIRIN CORPORATION SHIZUOKA-SHI | Manufacturer Registration holder, Manufacturer | General hospital and consumables, Patient monitoring and neurology, Orthopaedics, spine and trauma | 9 | 3 | 0 | 35.9 | 3/5 |
| 12 | Nihon Kohden Corporation - Eastern Japan Logistics Center Sakado City Saitama | Manufacturer Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 64 | 1 | 0 | 34.1 | 3/5 |
| 13 | Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center Tokorozawa Saitama | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 58 | 1 | 0 | 33.6 | 3/5 |
| 14 | Arthrex Japan G.K. (Shinjuku) Shinjuku-ku Tokyo | Manufacturer Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +3 more | 46 | 1 | 0 | 32.4 | 3/5 |
| 15 | DENTECH CORPORATION TOKYO | Manufacturer Manufacturer | Dental, Orthopaedics, spine and trauma, Surgery and endoscopy | 23 | 1 | 0 | 32.4 | 3/5 |
| 16 | Zimmer Biomet G.K. Hiratsuka Kanagawa | Manufacturer Exporter | Orthopaedics, spine and trauma, Surgery and endoscopy | 38 | 1 | 0 | 31.5 | 3/5 |
| 17 | KSI CO., LTD. Gotemba Shizuoka | Manufacturer Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 27 | 1 | 0 | 29.8 | 3/5 |
| 18 | KOGA ISOTOPE LTD. Koka-shi Shiga | Manufacturer Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +2 more | 19 | 1 | 0 | 28.1 | 3/5 |
| 19 | MEDMETALEX CO., LTD. Osaka | Manufacturer Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 16 | 1 | 0 | 27.3 | 3/5 |
| 20 | KYOCERA Medical Corporation Shiga Higashiomi Plant Higashiomi-shi Shiga | Manufacturer Manufacturer | Orthopaedics, spine and trauma | 12 | 1 | 0 | 25.9 | 3/5 |
Questions about orthopaedics, spine and trauma distributors in Japan
How many orthopaedics, spine and trauma distributors are there in Japan?
The Index counts 34 establishments in Japan with orthopaedics, spine and trauma in their registry record, of which 0 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), Health Canada and MHRA UK and was last refreshed on 22 October 2026.
Who can hold a orthopaedics, spine and trauma device registration in Japan?
In Japan the marketing approval or certification is held by a Marketing Authorisation Holder (MAH) based in Japan, or by a Designated MAH acting for a foreign manufacturer. The foreign manufacturer registers separately with PMDA. An independent D-MAH keeps the approval out of the distributor's hands.
How do I find a orthopaedics, spine and trauma distributor in Japan?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Japan to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a orthopaedics, spine and trauma distributor in Japan?
A company that appears in a public regulatory registry with an address in Japan and whose linked device listings fall in the orthopaedics, spine and trauma segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Japan
Orthopaedics, spine and trauma in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 31 establishments, last seen 23 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 11 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- UK MHRA Public Access Registration Database (PARD): 9 establishments, last seen 23 October 2026. Public register.
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.