Updated 22 October 2026
In-vitro diagnostics distributors in Japan: 99 licensed establishments
The Bastion Hale Distributor Index lists 99 establishments in Japan whose registry records include in-vitro diagnostics: 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 98 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.
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
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 | 16 | 16% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 96 | 97% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 18 | 18% | 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 in-vitro diagnostics 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 (99)
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 | TAKAHASHI KEISEI CORPORATION Yamagata | Maker's own entity Distributor, Manufacturer | In-vitro diagnostics | 2 | 1 | 0 | 20.8 | 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 | TOSOH CORPORATION Chuo-ku Tokyo | Manufacturer Registration holder, Manufacturer, Exporter | In-vitro diagnostics | 128 | 61 | 0 | 63.4 | 3/5 |
| 4 | 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 |
| 5 | SYSMEX CORPORATION KOBE Hyogo, Kobe | Manufacturer Registration holder, Manufacturer, Exporter | In-vitro diagnostics, Imaging, radiology and radiotherapy | 96 | 42 | 0 | 60.2 | 3/5 |
| 6 | TERUMO CORPORATION SHIBUYA-KU, TOKYO | Manufacturer Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +4 more | 69 | 35 | 0 | 57.8 | 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 | TOPCON CORPORATION TOKYO | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics, Ophthalmic, Imaging, radiology and radiotherapy +1 more | 45 | 31 | 0 | 53.5 | 3/5 |
| 9 | NIPRO CORPORATION Settsu Osaka | Manufacturer Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Dental +4 more | 51 | 30 | 0 | 55.5 | 3/5 |
| 10 | SHOFU INC. FUKUINE, HIGASHIYAMA-KU Kyoto | Manufacturer Registration holder, Manufacturer, Exporter | General hospital and consumables, Dental, In-vitro diagnostics | 79 | 24 | 0 | 56.7 | 3/5 |
| 11 | ARKRAY Factory, Inc. Koka-shi Shiga | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics, Ophthalmic, Surgery and endoscopy | 21 | 18 | 0 | 47.3 | 3/5 |
| 12 | OMRON HEALTHCARE CO., LTD. MUKO Kyoto | Manufacturer Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 26 | 17 | 0 | 48.1 | 3/5 |
| 13 | ATOM MEDICAL CORPORATION Sakura-ku, Saitama-shi | Manufacturer Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 24 | 13 | 0 | 48.1 | 3/5 |
| 14 | 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 |
| 15 | PHC Corporation TOON Ehime, Gunma | Manufacturer Manufacturer, Exporter | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 49 | 11 | 0 | 46.9 | 3/5 |
| 16 | Fujirebio Inc. Sagamihara-shi Kanagawa, Minato-ku | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics | 13 | 7 | 0 | 40.9 | 3/5 |
| 17 | EIKEN CHEMICAL CO., LTD. Chiyoda-ku Tokyo | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics | 15 | 5 | 0 | 40.2 | 3/5 |
| 18 | INAMI & CO., LTD. Bunkyo Tokyo | Manufacturer Manufacturer | General hospital and consumables, In-vitro diagnostics, Ophthalmic +2 more | 32 | 3 | 0 | 37.3 | 3/5 |
| 19 | OTSUKA ELECTRONICS CO., LTD. Koka-city Shiga | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics | 2 | 3 | 0 | 27.4 | 3/5 |
| 20 | NIDEK CO., LTD. HAMACHO PLANT GAMAGORI, AICHI | Manufacturer Manufacturer, Exporter | In-vitro diagnostics, Ophthalmic, Imaging, radiology and radiotherapy +1 more | 64 | 2 | 0 | 38.3 | 3/5 |
Questions about in-vitro diagnostics distributors in Japan
How many in-vitro diagnostics distributors are there in Japan?
The Index counts 99 establishments in Japan with in-vitro diagnostics 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 in-vitro diagnostics 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 in-vitro diagnostics 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 in-vitro diagnostics 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 in-vitro diagnostics 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
In-vitro diagnostics in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 98 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 29 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 16 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.