Updated 22 October 2026
ENT device distributors in Japan: 40 licensed establishments
The Bastion Hale Distributor Index lists 40 establishments in Japan whose registry records include ear, nose and throat: 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 39 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.
Ear, nose and throat covers hearing devices, cochlear implants, sinus and laryngology instruments, and audiology equipment. Hearing aids often go through retail audiology chains rather than hospital distributors, so the establishment list mixes both. Volumes per establishment are smaller than in surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 1 | 2% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 6 | 15% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 38 | 95% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 10 | 25% | 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 ear, nose and throat 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 (40)
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 | 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 |
| 2 | 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 |
| 3 | 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 |
| 4 | 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 |
| 5 | 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 |
| 6 | 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 |
| 7 | MIZUHO CORPORATION BUNKYO-KU Tokyo | Manufacturer Registration holder, Manufacturer, Exporter | General hospital and consumables, Ear, nose and throat, Patient monitoring and neurology +1 more | 29 | 7 | 0 | 46.4 | 3/5 |
| 8 | HOYA Corporation PENTAX Lifecare Division KURIHARA-SHI Miyagi | Manufacturer Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +3 more | 154 | 2 | 0 | 42.7 | 3/5 |
| 9 | Intuitive Surgical G.K. Tokyo | Manufacturer Manufacturer, Exporter | General hospital and consumables, Ear, nose and throat, Gastroenterology, urology and OB/GYN +2 more | 82 | 1 | 0 | 37.6 | 3/5 |
| 10 | AOMORI OLYMPUS CO., LTD. Kuroishi Site KUROISHI-SHI Aomori | Manufacturer Manufacturer | Ear, nose and throat, Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy +1 more | 104 | 1 | 0 | 36.5 | 3/5 |
| 11 | SHIRAKAWA OLYMPUS CO., LTD. NISHISHIRAKAWA-GUN Fukushima | Manufacturer Manufacturer | Ear, nose and throat, Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy +1 more | 103 | 1 | 0 | 36.5 | 3/5 |
| 12 | Aomori Olympus Co., Ltd. Hirosaki Site Hirosaki-shi Aomori | Manufacturer Manufacturer | Ear, nose and throat, Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy +1 more | 93 | 1 | 0 | 36.0 | 3/5 |
| 13 | AIZU OLYMPUS CO., LTD. AIZUWAKAMATSU-SHI Fukushima | Manufacturer Manufacturer | Ear, nose and throat, Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy | 78 | 1 | 0 | 35.1 | 3/5 |
| 14 | CHARMANT, INC. SABAE-CITY, FUKUI-PREF., FUKUI PREFECTURE | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Ear, nose and throat +4 more | 37 | 1 | 0 | 34.8 | 3/5 |
| 15 | FUJIFILM Corporation Medical Systems Research & Development Center Kaisei Ashigarakami-Gun Kanagawa | Manufacturer Manufacturer | Cardiovascular, Ear, nose and throat, Gastroenterology, urology and OB/GYN +1 more | 73 | 1 | 0 | 34.7 | 3/5 |
| 16 | Nihon Kohden Corporation - Eastern Japan Logistics Center Sakado City Saitama | Manufacturer Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 64 | 1 | 0 | 34.1 | 3/5 |
| 17 | FUJIFILM Healthcare Manufacturing Corporation Sano Office Sano City Tochigi | Manufacturer Manufacturer | Cardiovascular, Ear, nose and throat, Gastroenterology, urology and OB/GYN +1 more | 63 | 1 | 0 | 34.0 | 3/5 |
| 18 | ASHITAKA FACTORY OF TERUMO CORP. FUJINOMIYA Shizuoka | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Ear, nose and throat +1 more | 60 | 1 | 0 | 33.8 | 3/5 |
| 19 | Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center Tokorozawa Saitama | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 58 | 1 | 0 | 33.6 | 3/5 |
| 20 | RADIA INDUSTRY CO., LTD. Takasaki Gunma | Manufacturer Manufacturer | General hospital and consumables, Ear, nose and throat, Gastroenterology, urology and OB/GYN +3 more | 35 | 1 | 0 | 31.1 | 3/5 |
Questions about ear, nose and throat distributors in Japan
How many ear, nose and throat distributors are there in Japan?
The Index counts 40 establishments in Japan with ear, nose and throat 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 ear, nose and throat 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 ear, nose and throat 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 ear, nose and throat 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 ear, nose and throat 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
Ear, nose and throat in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 39 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 7 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 6 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.