Updated 22 October 2026
In-vitro diagnostics distributors in Mexico: 890 licensed establishments
The Bastion Hale Distributor Index lists 890 establishments in Mexico 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), 310 manufacturers' own import or sales entities, 509 regulatory representatives, and 71 manufacturers or exporters, out of 2,964 medical device establishments in Mexico overall. The records come from COFEPRIS Mexico and US FDA (openFDA), last seen on 23 October 2026.
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 | 2 | 0% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 833 | 94% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 72 | 8% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 20 | 2% | 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.
Top 0 independent in-vitro diagnostics 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 (889)
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 | PRODUCTOS ROCHE, S.A. DE C.V. | Maker's own entity Registration holder | Anaesthesia and respiratory, Cardiovascular, Ear, nose and throat +5 more | 369 | 369 | 0 | 64.6 | 2/5 |
| 2 | SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V. | Maker's own entity Registration holder | Cardiovascular, Dental, Ear, nose and throat +4 more | 341 | 341 | 0 | 64.2 | 2/5 |
| 3 | INSUMOS PARA LA SALUD, S.A. DE C.V. | Maker's own entity Registration holder | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 254 | 254 | 0 | 62.7 | 2/5 |
| 4 | GRIFOLS MÉXICO, S.A. DE C.V. | Maker's own entity Registration holder | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +4 more | 181 | 181 | 0 | 60.6 | 2/5 |
| 5 | BECKMAN COULTER DE MÉXICO, S.A. DE C.V. | Maker's own entity Registration holder | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +4 more | 161 | 161 | 0 | 59.4 | 2/5 |
| 6 | MINDRAY MEDICAL MÉXICO, S. DE R.L. DE C.V. | Maker's own entity Registration holder | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 161 | 161 | 0 | 59.4 | 2/5 |
| 7 | BIOMET MÉXICO, S.A. DE C.V. Mexico City Ciudad de Mexico | Maker's own entity Registration holder, Exporter | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +5 more | 142 | 143 | 0 | 63.9 | 3/5 |
| 8 | MEDTRONIC, S. DE R.L. DE C.V. | Maker's own entity Registration holder | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +9 more | 138 | 138 | 0 | 57.9 | 2/5 |
| 9 | CREATIVE INNOVATIONS CA, S.A. DE C.V. | Maker's own entity Registration holder | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 120 | 120 | 0 | 56.6 | 2/5 |
| 10 | JOHNSON & JOHNSON DE MÉXICO, S.A. DE C.V. | Maker's own entity Registration holder | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +6 more | 117 | 117 | 0 | 56.3 | 2/5 |
| 11 | DIASORIN MÉXICO, S.A. DE C.V. | Maker's own entity Registration holder | Cardiovascular, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +2 more | 116 | 116 | 0 | 56.2 | 2/5 |
| 12 | BOSTON SCIENTIFIC DE MÉXICO, S.A. DE C.V. | Maker's own entity Registration holder | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +7 more | 109 | 109 | 0 | 55.6 | 2/5 |
| 13 | BIO-RAD SA DE CV | Maker's own entity Registration holder | Cardiovascular, Ear, nose and throat, In-vitro diagnostics +2 more | 104 | 104 | 0 | 55.2 | 2/5 |
| 14 | MEDLINE MÉXICO, S. DE R.L. DE C.V. | Maker's own entity Registration holder | Anaesthesia and respiratory, General hospital and consumables, Dental +8 more | 100 | 100 | 0 | 54.8 | 2/5 |
| 15 | KENDALL DE MÉXICO, S.A. DE C.V. | Maker's own entity Registration holder | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 97 | 97 | 0 | 54.5 | 2/5 |
| 16 | STRYKER MÉXICO, S.A. DE C.V. | Maker's own entity Registration holder | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +7 more | 86 | 86 | 0 | 53.3 | 2/5 |
| 17 | SMITH & NEPHEW, S.A. DE C.V. | Maker's own entity Registration holder | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +5 more | 83 | 83 | 0 | 53.0 | 2/5 |
| 18 | AUXEIN MÉXICO, S.A. DE C.V. | Maker's own entity Registration holder | Cardiovascular, General hospital and consumables, In-vitro diagnostics +2 more | 74 | 74 | 0 | 51.9 | 2/5 |
| 19 | BIOMÉRIEUX MÉXICO, S.A. DE C.V. | Maker's own entity Registration holder | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +5 more | 73 | 73 | 0 | 51.8 | 2/5 |
| 20 | HIOSSEN DE MÉXICO, S.A. DE C.V. | Maker's own entity Registration holder | Anaesthesia and respiratory, General hospital and consumables, Dental +5 more | 73 | 73 | 0 | 51.8 | 2/5 |
Questions about in-vitro diagnostics distributors in Mexico
How many in-vitro diagnostics distributors are there in Mexico?
The Index counts 890 establishments in Mexico 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 COFEPRIS Mexico and US FDA (openFDA) and was last refreshed on 22 October 2026.
Who can hold a in-vitro diagnostics 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 a in-vitro diagnostics 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 reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a in-vitro diagnostics 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 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 Mexico
In-vitro diagnostics in other Latin America and the Caribbean markets
Sources
- Mexico COFEPRIS medical device registrations (registros sanitarios): 833 establishments, last seen 23 October 2026. Mexican government publication.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 78 establishments, last seen 23 October 2026. US government work, public domain.
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.