Updated 22 October 2026
Medical device distributors in Japan: 568 licensed establishments
The Bastion Hale Distributor Index lists 568 medical device establishments registered with an address in Japan: 2 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 11 manufacturers' own import or sales entities, 0 regulatory representatives (authorised representatives or registration holders with no import or distribution role), and 555 manufacturers or exporters. The records come from US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 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.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 13 | 2% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 57 | 10% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 537 | 95% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 106 | 19% | 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 it per market.
Top 2 independent distributors
Independent distributors only: a channel role (importer, distributor, wholesaler, authorised representative), no manufacturing of their own and no sign of being a manufacturer's own sales company. Ranked by the other manufacturers' lines they carry, then registrations held, then size (a 0 to 100 score). Complete is 0 to 5 for website, address, segments, principals and counts.
Only 2 independent distributors are registered here; the rest are manufacturers or their own sales entities.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | KAMEMANNEN CO., LTD. Sabae, Fukui | Distributor Distributor, Exporter | Ophthalmic | 2 | 1 | 0 | 20.8 | 3/5 |
| 2 | G.U. CO. LTD. YAMAGUCHI CITY | Distributor Distributor | Ophthalmic | 1 | 1 | 0 | 16.5 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (566)
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 | SHIKEN CORPORATION Osaka | Maker's own entity Distributor, Manufacturer, Exporter | Dental | 6 | 2 | 0 | 28.6 | 3/5 |
| 2 | 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 |
| 3 | PARAMOUNT BED CO., LTD. Chiba Factory Sammu-shi Chiba | Maker's own entity Distributor, Manufacturer | General hospital and consumables, Patient monitoring and neurology | 6 | 1 | 0 | 25.1 | 3/5 |
| 4 | LITM INC. Fukui | Maker's own entity Distributor, Manufacturer, Exporter | Ophthalmic | 3 | 1 | 0 | 23.8 | 3/5 |
| 5 | ATELIER CINQ CO., LTD Minato-Ku Tokyo | Maker's own entity Distributor, Manufacturer, Exporter | Ophthalmic | 2 | 1 | 0 | 22.4 | 3/5 |
| 6 | BETHEL CO., LTD. Ishioka Ibaraki | Maker's own entity Distributor, Manufacturer, Exporter | Dental | 2 | 1 | 0 | 22.4 | 3/5 |
| 7 | SUPLUS CO., LTD. Shinjuku-ku Tokyo | Maker's own entity Distributor, Manufacturer, Exporter | Ophthalmic | 2 | 1 | 0 | 22.4 | 3/5 |
| 8 | TAKAHASHI KEISEI CORPORATION Yamagata | Maker's own entity Distributor, Manufacturer | In-vitro diagnostics | 2 | 1 | 0 | 20.8 | 3/5 |
| 9 | ATEX CO., LTD. Osaka | Maker's own entity Distributor, Manufacturer, Exporter | Patient monitoring and neurology | 1 | 1 | 0 | 20.3 | 3/5 |
| 10 | SHINNNICHI CORPORATION CO.,LTD Higashi-Osaka | Maker's own entity Distributor, Manufacturer, Exporter | Dental | 1 | 1 | 0 | 20.3 | 3/5 |
| 11 | Nishio Co., Ltd Chiba | Maker's own entity Distributor, Manufacturer | Dental | 1 | 1 | 0 | 18.7 | 3/5 |
| 12 | 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 |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |
| 16 | TOSOH CORPORATION Chuo-ku Tokyo | Manufacturer Registration holder, Manufacturer, Exporter | In-vitro diagnostics | 128 | 61 | 0 | 63.4 | 3/5 |
| 17 | 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 |
| 18 | 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 |
| 19 | 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 |
| 20 | SYSMEX CORPORATION KOBE Hyogo, Kobe | Manufacturer Registration holder, Manufacturer, Exporter | In-vitro diagnostics, Imaging, radiology and radiotherapy | 96 | 42 | 0 | 60.2 | 3/5 |
Questions about medical device distributors in Japan
How many medical device distributors are there in Japan?
The Index counts 568 medical device establishments registered in Japan, of which 2 are independent distributors: importers, distributors, wholesalers or authorised representatives that do not manufacture themselves and are not a manufacturer's own sales company. The rest are manufacturers or their own sales entities. The number comes from US FDA (openFDA), MHRA UK and Health Canada and was last refreshed on 22 October 2026.
Who can hold a medical 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 medical device distributor in Japan?
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 Japan to see the counts for your segment and reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a distributor in Japan?
An establishment is a company that appears in a public regulatory registry with an address in Japan, 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 Japan
Related markets in Asia Pacific
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 510 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 132 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 57 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.