Updated 23 October 2026
In-vitro diagnostics distributors in Japan: 99 licensed establishments
Japan has 99 licensed establishments in the Index and no independent distributor yet.
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.
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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.
- 1TAKAHASHI KEISEI CORPORATIONYamagata0 lines1 registrationsize 20.8
- 2CANON INC.Kawasaki Kanagawa0 lines129 registrationssize 73.7
- 3TOSOH CORPORATIONChuo-ku Tokyo0 lines61 registrationssize 63.4
- 4NIDEK CO., LTD.Gamagori0 lines57 registrationssize 58.5
- 5SYSMEX CORPORATIONKOBE Hyogo, Kobe0 lines42 registrationssize 60.2
- 6TERUMO CORPORATIONSHIBUYA-KU, TOKYO0 lines35 registrationssize 57.8
- 7NIHON KOHDEN CORPORATIONSHINJUKU-KU Tokyo, Tokyo0 lines33 registrationssize 57.3
- 8TOPCON CORPORATIONTOKYO0 lines31 registrationssize 53.5
- 9NIPRO CORPORATIONSettsu Osaka0 lines30 registrationssize 55.5
- 10SHOFU INC.FUKUINE, HIGASHIYAMA-KU Kyoto0 lines24 registrationssize 56.7
- 11ARKRAY Factory, Inc.Koka-shi Shiga0 lines18 registrationssize 47.3
- 12OMRON HEALTHCARE CO., LTD.MUKO Kyoto0 lines17 registrationssize 48.1
- 13ATOM MEDICAL CORPORATIONSakura-ku, Saitama-shi0 lines13 registrationssize 48.1
- 140 lines12 registrationssize 44.2
- 15PHC CorporationTOON Ehime, Gunma0 lines11 registrationssize 46.9
- 16Fujirebio Inc.Sagamihara-shi Kanagawa, Minato-ku0 lines7 registrationssize 40.9
- 17EIKEN CHEMICAL CO., LTD.Chiyoda-ku Tokyo0 lines5 registrationssize 40.2
- 18INAMI & CO., LTD.Bunkyo Tokyo0 lines3 registrationssize 37.3
- 19OTSUKA ELECTRONICS CO., LTD.Koka-city Shiga0 lines3 registrationssize 27.4
- 20NIDEK CO., LTD. HAMACHO PLANTGAMAGORI, AICHI0 lines2 registrationssize 38.3
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.
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 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 23 October 2026.
Who can hold an 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 an 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 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 an 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 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.