Updated 22 October 2026
Surgical and endoscopy device distributors in Japan: 86 licensed establishments
The Bastion Hale Distributor Index lists 86 establishments in Japan whose registry records include surgery and endoscopy: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 1 manufacturers' own import or sales entities, 0 regulatory representatives, and 85 manufacturers or exporters, out of 568 medical device establishments in Japan overall. The records come from US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 October 2026.
General and plastic surgery covers instruments, electrosurgery, endoscopes, sutures and staplers. Most registries place surgical instruments in their largest category, so this segment usually has the most establishments and the widest spread of company sizes. Many of them are small instrument makers and importers rather than full-line distributors.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 1 | 1% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 15 | 17% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 80 | 93% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 20 | 23% | 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 surgery and endoscopy 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 (86)
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 | Daiso Industries Co., Ltd. Higashihiroshima | Maker's own entity Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +5 more | 34 | 1 | 0 | 34.8 | 3/5 |
| 2 | 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 |
| 3 | 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 |
| 4 | 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 |
| 5 | 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 |
| 6 | PENTAX MEDICAL CORPORATION Tokyo | Manufacturer Registration holder, Manufacturer | Cardiovascular, Ear, nose and throat, Gastroenterology, urology and OB/GYN +2 more | 52 | 51 | 0 | 54.1 | 3/5 |
| 7 | TOPCON CORPORATION TOKYO | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics, Ophthalmic, Imaging, radiology and radiotherapy +1 more | 45 | 31 | 0 | 53.5 | 3/5 |
| 8 | NIPRO CORPORATION Settsu Osaka | Manufacturer Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Dental +4 more | 51 | 30 | 0 | 55.5 | 3/5 |
| 9 | GE Healthcare Japan Corporation HINO-SHI Tokyo | Manufacturer Registration holder, Manufacturer | Cardiovascular, Patient monitoring and neurology, Imaging, radiology and radiotherapy +1 more | 122 | 20 | 0 | 56.5 | 3/5 |
| 10 | ARKRAY Factory, Inc. Koka-shi Shiga | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics, Ophthalmic, Surgery and endoscopy | 21 | 18 | 0 | 47.3 | 3/5 |
| 11 | TOGO MEDIKIT CO., LTD. HYUGA CITY Miyazaki | Manufacturer Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Surgery and endoscopy | 9 | 14 | 0 | 43.8 | 3/5 |
| 12 | FEATHER SAFETY RAZOR CO., LTD. OSAKA | Manufacturer Registration holder, Manufacturer | General hospital and consumables, In-vitro diagnostics, Ophthalmic +1 more | 16 | 12 | 0 | 44.2 | 3/5 |
| 13 | 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 |
| 14 | MIZUHO CORPORATION BUNKYO-KU Tokyo | Manufacturer Registration holder, Manufacturer, Exporter | General hospital and consumables, Ear, nose and throat, Patient monitoring and neurology +1 more | 29 | 7 | 0 | 46.4 | 3/5 |
| 15 | TAKARA BELMONT CORPORATION OSAKA | Manufacturer Registration holder, Manufacturer | Dental, Imaging, radiology and radiotherapy, Surgery and endoscopy | 15 | 6 | 0 | 41.0 | 3/5 |
| 16 | J. MORITA MFG. CORP. FUSHIMI-KU Kyoto | Manufacturer Manufacturer, Exporter | Dental, Imaging, radiology and radiotherapy, Surgery and endoscopy | 22 | 3 | 0 | 37.7 | 3/5 |
| 17 | INAMI & CO., LTD. Bunkyo Tokyo | Manufacturer Manufacturer | General hospital and consumables, In-vitro diagnostics, Ophthalmic +2 more | 32 | 3 | 0 | 37.3 | 3/5 |
| 18 | Unisis Corporation Koshigaya-shi Saitama | Manufacturer Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Gastroenterology, urology and OB/GYN +1 more | 23 | 3 | 0 | 35.7 | 3/5 |
| 19 | TSK Laboratory International Japan KK Tochigi | Manufacturer Registration holder, Manufacturer, Exporter | General hospital and consumables, Ophthalmic, Surgery and endoscopy | 5 | 3 | 0 | 32.5 | 3/5 |
| 20 | GUNZE LIMITED Ayabe Kyoto | Manufacturer Manufacturer | General hospital and consumables, Surgery and endoscopy | 4 | 3 | 0 | 27.8 | 3/5 |
Questions about surgery and endoscopy distributors in Japan
How many surgery and endoscopy distributors are there in Japan?
The Index counts 86 establishments in Japan with surgery and endoscopy 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), MHRA UK and Health Canada and was last refreshed on 22 October 2026.
Who can hold a surgery and endoscopy 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 surgery and endoscopy 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 surgery and endoscopy 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 surgery and endoscopy 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
Surgery and endoscopy in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 85 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 28 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 15 establishments, last seen 23 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.