Updated 23 October 2026
Surgical and endoscopy device distributors in Japan: 86 licensed establishments
Japan has 86 licensed establishments in the Index and no independent distributor yet.
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.
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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.
- 1Daiso Industries Co., Ltd.Higashihiroshima0 lines1 registrationsize 34.8
- 2OLYMPUS MEDICAL SYSTEMS CORP.HACHIOJI-SHI Tokyo, Hachioji-shi0 lines229 registrationssize 74.0
- 3CANON INC.Kawasaki Kanagawa0 lines129 registrationssize 73.7
- 4FUJIFILM CORPORATIONASHIGARAKAMI-GUN Kanagawa0 lines87 registrationssize 64.7
- 5NAKANISHI INC.Kanuma Tochigi0 lines70 registrationssize 65.9
- 60 lines51 registrationssize 54.1
- 7TOPCON CORPORATIONTOKYO0 lines31 registrationssize 53.5
- 8NIPRO CORPORATIONSettsu Osaka0 lines30 registrationssize 55.5
- 9GE Healthcare Japan CorporationHINO-SHI Tokyo0 lines20 registrationssize 56.5
- 10ARKRAY Factory, Inc.Koka-shi Shiga0 lines18 registrationssize 47.3
- 11TOGO MEDIKIT CO., LTD.HYUGA CITY Miyazaki0 lines14 registrationssize 43.8
- 120 lines12 registrationssize 44.2
- 13TSK LABORATORY, JAPANTOCHIGI-SHI, Tochigi-Ken0 lines9 registrationssize 40.7
- 14MIZUHO CORPORATIONBUNKYO-KU Tokyo0 lines7 registrationssize 46.4
- 150 lines6 registrationssize 41.0
- 16J. MORITA MFG. CORP.FUSHIMI-KU Kyoto0 lines3 registrationssize 37.7
- 17INAMI & CO., LTD.Bunkyo Tokyo0 lines3 registrationssize 37.3
- 18Unisis CorporationKoshigaya-shi Saitama0 lines3 registrationssize 35.7
- 190 lines3 registrationssize 32.5
- 20GUNZE LIMITEDAyabe Kyoto0 lines3 registrationssize 27.8
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.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later. The Next 10 Markets report covers who holds the registration in each of your ten markets.
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 23 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 see the top three names. For a ranked shortlist for your device, see 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 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.