Updated 23 October 2026
Orthopaedic and spine device distributors in Mexico: 534 licensed establishments
Mexico has 534 licensed establishments in the Index and no independent distributor yet.
The Bastion Hale Distributor Index lists 534 establishments in Mexico whose registry records include orthopaedics, spine and trauma: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 176 manufacturers' own import or sales entities, 307 regulatory representatives, and 51 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 (534)
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 lines161 registrationssize 59.4
- 50 lines161 registrationssize 59.4
- 6BIOMET MÉXICO, S.A. DE C.V.Mexico City Ciudad de Mexico0 lines143 registrationssize 63.9
- 70 lines138 registrationssize 57.9
- 80 lines120 registrationssize 56.6
- 90 lines117 registrationssize 56.3
- 100 lines116 registrationssize 56.2
- 110 lines109 registrationssize 55.6
- 120 lines104 registrationssize 55.2
- 130 lines100 registrationssize 54.8
- 140 lines97 registrationssize 54.5
- 150 lines86 registrationssize 53.3
- 160 lines83 registrationssize 53.0
- 170 lines74 registrationssize 51.9
- 180 lines73 registrationssize 51.8
- 190 lines73 registrationssize 51.8
- 200 lines71 registrationssize 51.5
Orthopaedics covers implants for joints, spine and trauma, together with instruments and bone substitutes. Implants are usually Class IIb or III, so the importer or registration holder carries real regulatory work and hospitals often buy through tenders. Distributors in this segment tend to employ clinical support staff who attend surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Registration holder | 495 | 93% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 50 | 9% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 16 | 3% | 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 orthopaedics, spine and trauma distributors in Mexico
How many orthopaedics, spine and trauma distributors are there in Mexico?
The Index counts 534 establishments in Mexico with orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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
Orthopaedics, spine and trauma in other Latin America and the Caribbean markets
Sources
- Mexico COFEPRIS medical device registrations (registros sanitarios): 495 establishments, last seen 23 October 2026. Mexican government publication.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 54 establishments, last seen 23 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 2 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- UK MHRA Public Access Registration Database (PARD): 2 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.