Updated 22 October 2026
Medical device distributors in Japan: 526 licensed establishments
The Bastion Hale Distributor Index lists 526 medical device establishments registered with an address in Japan: 13 with a channel role (importer, distributor, wholesaler or authorised representative), 57 registration holders without a channel role, and 456 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.
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 | 11% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 494 | 94% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 106 | 20% | 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 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 | Daiso Industries Co., Ltd. Higashihiroshima | Channel Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +5 more | 34 | 1 | 0 | 34.8 | 3/5 |
| 2 | SHIKEN CORPORATION Osaka | Channel Distributor, Manufacturer, Exporter | Dental | 6 | 2 | 0 | 28.6 | 3/5 |
| 3 | PARAMOUNT BED CO., LTD. Chiba Factory Sammu-shi Chiba | Channel Distributor, Manufacturer | General hospital and consumables, Patient monitoring and neurology | 6 | 1 | 0 | 25.1 | 3/5 |
| 4 | LITM INC. Fukui | Channel Distributor, Manufacturer, Exporter | Ophthalmic | 3 | 1 | 0 | 23.8 | 3/5 |
| 5 | ATELIER CINQ CO., LTD Minato-Ku Tokyo | Channel Distributor, Manufacturer, Exporter | Ophthalmic | 2 | 1 | 0 | 22.4 | 3/5 |
| 6 | BETHEL CO., LTD. Ishioka Ibaraki | Channel Distributor, Manufacturer, Exporter | Dental | 2 | 1 | 0 | 22.4 | 3/5 |
| 7 | SUPLUS CO., LTD. Shinjuku-ku Tokyo | Channel Distributor, Manufacturer, Exporter | Ophthalmic | 2 | 1 | 0 | 22.4 | 3/5 |
| 8 | KAMEMANNEN CO., LTD. Sabae, Fukui | Channel Distributor, Exporter | Ophthalmic | 2 | 1 | 0 | 20.8 | 3/5 |
| 9 | TAKAHASHI KEISEI CORPORATION Yamagata | Channel Distributor, Manufacturer | In-vitro diagnostics | 2 | 1 | 0 | 20.8 | 3/5 |
| 10 | ATEX CO., LTD. Osaka | Channel Distributor, Manufacturer, Exporter | Patient monitoring and neurology | 1 | 1 | 0 | 20.3 | 3/5 |
| 11 | SHINNNICHI CORPORATION CO.,LTD Higashi-Osaka | Channel Distributor, Manufacturer, Exporter | Dental | 1 | 1 | 0 | 20.3 | 3/5 |
| 12 | Nishio Co., Ltd Chiba | Channel Distributor, Manufacturer | Dental | 1 | 1 | 0 | 18.7 | 3/5 |
| 13 | G.U. CO. LTD. YAMAGUCHI CITY | Channel Distributor | Ophthalmic | 1 | 1 | 0 | 16.5 | 3/5 |
| 14 | OLYMPUS MEDICAL SYSTEMS CORP. HACHIOJI-SHI Tokyo | Holder Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 351 | 183 | 0 | 71.2 | 3/5 |
| 15 | CANON INC. Kawasaki Kanagawa | Holder Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 673 | 107 | 0 | 70.4 | 3/5 |
| 16 | NAKANISHI INC. Kanuma Tochigi | Holder Registration holder, Manufacturer | Dental, Ear, nose and throat, Patient monitoring and neurology +2 more | 411 | 70 | 0 | 65.9 | 3/5 |
| 17 | FUJIFILM CORPORATION ASHIGARAKAMI-GUN Kanagawa | Holder Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +4 more | 163 | 60 | 0 | 60.5 | 3/5 |
| 18 | KURARAY NORITAKE DENTAL INC. Kurashiki | Holder Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +2 more | 258 | 50 | 0 | 58.6 | 3/5 |
| 19 | SYSMEX CORPORATION KOBE Hyogo | Holder Registration holder, Manufacturer, Exporter | In-vitro diagnostics, Imaging, radiology and radiotherapy | 96 | 30 | 0 | 56.3 | 3/5 |
| 20 | TERUMO CORPORATION SHIBUYA-KU, TOKYO | Holder Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +4 more | 69 | 32 | 0 | 54.9 | 3/5 |
Questions about medical device distributors in Japan
How many medical device distributors are there in Japan?
The Index counts 526 medical device establishments registered in Japan, of which 13 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 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 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 57 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.