Updated 23 October 2026
ENT device distributors in Mexico: 236 licensed establishments
Mexico has 236 licensed establishments in the Index and no independent distributor yet.
The Bastion Hale Distributor Index lists 236 establishments in Mexico 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), 81 manufacturers' own import or sales entities, 94 regulatory representatives, and 61 manufacturers or exporters, out of 2,964 medical device establishments in Mexico overall. The records come from COFEPRIS Mexico, US FDA (openFDA), Health Canada and MHRA UK, last seen on 23 October 2026.
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Include manufacturers, their own sales entities and regulatory representatives (236)
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.
- 10 lines369 registrationssize 64.6
- 20 lines341 registrationssize 64.2
- 30 lines254 registrationssize 62.7
- 40 lines138 registrationssize 57.9
- 50 lines120 registrationssize 56.6
- 60 lines104 registrationssize 55.2
- 70 lines100 registrationssize 54.8
- 80 lines97 registrationssize 54.5
- 90 lines83 registrationssize 53.0
- 100 lines73 registrationssize 51.8
- 110 lines71 registrationssize 51.5
- 120 lines64 registrationssize 50.5
- 130 lines57 registrationssize 49.4
- 140 lines49 registrationssize 47.9
- 150 lines42 registrationssize 46.5
- 160 lines42 registrationssize 46.5
- 170 lines41 registrationssize 46.2
- 180 lines33 registrationssize 44.2
- 190 lines33 registrationssize 44.2
- 200 lines32 registrationssize 43.9
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 | 0% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 184 | 78% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 61 | 26% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 14 | 6% | 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 Mexico
In Mexico the COFEPRIS sanitary registration is held by a Mexican entity, usually the distributor or a local holder of record. Transfers between holders are possible but slow, so decide the holder before signing.
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 ear, nose and throat distributors in Mexico
How many ear, nose and throat distributors are there in Mexico?
The Index counts 236 establishments in Mexico 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 COFEPRIS Mexico, US FDA (openFDA), Health Canada and MHRA UK and was last refreshed on 23 October 2026.
Who can hold an ear, nose and throat device registration in Mexico?
In Mexico the COFEPRIS sanitary registration is held by a Mexican entity, usually the distributor or a local holder of record. Transfers between holders are possible but slow, so decide the holder before signing.
How do I find an ear, nose and throat distributor in Mexico?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Mexico 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 ear, nose and throat distributor in Mexico?
A company that appears in a public regulatory registry with an address in Mexico 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 Mexico
Ear, nose and throat in other Latin America and the Caribbean markets
Sources
- Mexico COFEPRIS medical device registrations (registros sanitarios): 184 establishments, last seen 23 October 2026. Mexican government publication.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 65 establishments, last seen 23 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 1 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- UK MHRA Public Access Registration Database (PARD): 1 establishments, last seen 23 October 2026. Public register.
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.