Updated 23 October 2026
Cardiovascular device distributors in Japan: 73 licensed establishments
Japan has 73 licensed establishments in the Index and no independent distributor yet.
The Bastion Hale Distributor Index lists 73 establishments in Japan whose registry records include cardiovascular: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 0 manufacturers' own import or sales entities, 0 regulatory representatives, and 73 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 (73)
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.
- 1OLYMPUS MEDICAL SYSTEMS CORP.HACHIOJI-SHI Tokyo, Hachioji-shi0 lines229 registrationssize 74.0
- 2CANON INC.Kawasaki Kanagawa0 lines129 registrationssize 73.7
- 3FUJIFILM CORPORATIONASHIGARAKAMI-GUN Kanagawa0 lines87 registrationssize 64.7
- 40 lines51 registrationssize 54.1
- 5TERUMO CORPORATIONSHIBUYA-KU, TOKYO0 lines35 registrationssize 57.8
- 6NIHON KOHDEN CORPORATIONSHINJUKU-KU Tokyo, Tokyo0 lines33 registrationssize 57.3
- 7ASAHI INTECC CO., LTD.SETO Aichi, Aichi0 lines31 registrationssize 56.3
- 8NIPRO CORPORATIONSettsu Osaka0 lines30 registrationssize 55.5
- 9GE Healthcare Japan CorporationHINO-SHI Tokyo0 lines20 registrationssize 56.5
- 10OMRON HEALTHCARE CO., LTD.MUKO Kyoto0 lines17 registrationssize 48.1
- 11SHIMADZU CORPORATIONNakagyo-Ku0 lines16 registrationssize 49.6
- 12TOGO MEDIKIT CO., LTD.HYUGA CITY Miyazaki0 lines14 registrationssize 43.8
- 13ATOM MEDICAL CORPORATIONSakura-ku, Saitama-shi0 lines13 registrationssize 48.1
- 14Kitazato CorporationMinato-ku Tokyo, Shizuoka0 lines12 registrationssize 49.1
- 15FUKUDA DENSHI CO., LTD.Bunkyo-ku Tokyo0 lines8 registrationssize 41.3
- 16TORAY INDUSTRIES, INC.CHUO-KU Tokyo0 lines7 registrationssize 37.4
- 17FUJI SYSTEMS CORPORATIONNishi Shirakawa Gun0 lines5 registrationssize 30.2
- 18TERUMO CLINICAL SUPPLY CO., LTD.Kakamigahara Gifu0 lines4 registrationssize 29.9
- 19Anzai Medical Co., Ltd.SHINAGAWA-KU Tokyo0 lines3 registrationssize 39.2
- 20NEMOTO KYORINDO CO., LTD.KAWAGUCHI-SHI Saitama0 lines3 registrationssize 31.3
Cardiovascular covers stents, catheters, pacemakers, heart valves, ECG and vascular access. Most products are implantable or high risk, which concentrates the segment in fewer, better capitalised importers. Reimbursement rules shape who can sell here more than in any other segment.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Registration holder | 19 | 26% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 69 | 95% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 11 | 15% | 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 cardiovascular distributors in Japan
How many cardiovascular distributors are there in Japan?
The Index counts 73 establishments in Japan with cardiovascular 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 cardiovascular 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 cardiovascular 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 cardiovascular 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 cardiovascular 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
Cardiovascular in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 70 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 26 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 19 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.