Who holds medical device registrations in Mexico

Who may hold a registration in Mexico

COFEPRIS grants the registro sanitario to its titular, the person or company that holds the Health Ministry's authorisation to make, import, distribute or sell the device.

The local term is titular del registro sanitario.

Sources: NOM-137-SSA1-2008, numeral 3.30.

COFEPRIS registration holders in Mexico: top 50

Ranked by COFEPRIS registrations. Each name opens its profile with roles, principals and sources.

1. 1
   ISA HEALTH, S.A. DE C.V.Ciudad de Mexico
   441 registrationsRegulatory representative
2. 2
   EMERGO, S. DE R.L. DE C.V.
   426 registrationsRegulatory representative
3. 3
   KABLA COMERCIAL, S.A. DE C.V.Guadalupe, Nuevo Leon
   411 registrationsDistributor
4. 4
   ABBOTT LABORATORIES DE MÉXICO, S.A. DE C.V.Cuautitlan Izcalli Mexico
   386 registrationsManufacturer
5. 5
   PRODUCTOS ROCHE, S.A. DE C.V.
   369 registrationsMaker's own entity
6. 6
   SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V.
   341 registrationsMaker's own entity
7. 7
   INOCHEM, S.A. DE C.V.Tlalpan, Ciudad de Mexico
   303 registrationsMaker's own entity
8. 8
   INSUMOS PARA LA SALUD, S.A. DE C.V.
   254 registrationsMaker's own entity
9. 9
   GRIFOLS MÉXICO, S.A. DE C.V.
   181 registrationsMaker's own entity
10. 10
    I.L. DIAGNOSTICS, S.A. DE C.V.Miguel Hidalgo, Ciudad de Mexico
    174 registrationsMaker's own entity
11. 11
    DEGASA, S.A. DE C.V.Jiutepec Morelos
    174 registrationsManufacturer
12. 12
    MINDRAY MEDICAL MÉXICO, S. DE R.L. DE C.V.
    161 registrationsMaker's own entity
13. 13
    BECKMAN COULTER DE MÉXICO, S.A. DE C.V.
    161 registrationsMaker's own entity
14. 14
    BIOMET MÉXICO, S.A. DE C.V.Mexico City Ciudad de Mexico
    142 registrationsMaker's own entity
15. 15
    MEDTRONIC, S. DE R.L. DE C.V.
    138 registrationsMaker's own entity
16. 16
    QUIMIBIOL, S.A. DE C.V.
    138 registrationsRegulatory representative
17. 17
    CREATIVE INNOVATIONS CA, S.A. DE C.V.
    120 registrationsMaker's own entity
18. 18
    JOHNSON & JOHNSON DE MÉXICO, S.A. DE C.V.
    117 registrationsMaker's own entity
19. 19
    DIASORIN MÉXICO, S.A. DE C.V.
    116 registrationsMaker's own entity
20. 20
    BOSTON SCIENTIFIC DE MÉXICO, S.A. DE C.V.
    109 registrationsMaker's own entity
21. 21
    BIO-RAD SA DE CV
    104 registrationsMaker's own entity
22. 22
    MEDLINE MÉXICO, S. DE R.L. DE C.V.
    100 registrationsMaker's own entity
23. 23
    KENDALL DE MÉXICO, S.A. DE C.V.
    97 registrationsMaker's own entity
24. 24
    SUMINISTRO PARA USO MÉDICO Y HOSPITALARIO, S.A. DE C.V.
    97 registrationsRegulatory representative
25. 25
    LEVBETH MEDICAL, S.A. DE C.V.Monterrey, Nuevo Leon
    90 registrationsDistributor
26. 26
    CORPORINTER, S.A. DE C.V.Zapopan, Jalisco
    88 registrationsDistributor
27. 27
    STRYKER MÉXICO, S.A. DE C.V.
    86 registrationsMaker's own entity
28. 28
    REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.
    86 registrationsRegulatory representative
29. 29
    MEDSTENT, S.A. DE C.V.
    83 registrationsDistributor
30. 30
    SMITH & NEPHEW, S.A. DE C.V.
    83 registrationsMaker's own entity
31. 31
    AGUILAR MURGUÍA ASESORES EN SERVICIOS INTEGRALES DE SALUD, S.A. DE C.V.Benito Juarez, Ciudad de Mexico
    82 registrationsRegulatory representative
32. 32
    BESELTA ANALYTICS, S.A. DE C.V.Naucalpan de Juarez, Estado de Mexico
    79 registrationsManufacturer
33. 33
    PROMESURGICAL, S.A. DE C.V.
    79 registrationsRegulatory representative
34. 34
    3M MÉXICO, S.A. DE C.V.
    76 registrationsMaker's own entity
35. 35
    AUXEIN MÉXICO, S.A. DE C.V.
    74 registrationsMaker's own entity
36. 36
    BIOMÉRIEUX MÉXICO, S.A. DE C.V.
    73 registrationsMaker's own entity
37. 37
    HIOSSEN DE MÉXICO, S.A. DE C.V.
    73 registrationsMaker's own entity
38. 38
    MANDALA MÉXICO LEGAL AFFAIRS, S.A. DE C.V.
    73 registrationsRegulatory representative
39. 39
    ABALAT, S.A. DE C.V.Ciudad de México
    71 registrationsDistributor
40. 40
    FUJIFILM DE MÉXICO, S.A. DE C.V.
    71 registrationsMaker's own entity
41. 41
    VERAQUE, S. DE R.L. DE C.V.
    70 registrationsRegulatory representative
42. 42
    ALEACIONES DENTALES ZEYCO, S.A. DE C.V.Zapopan
    68 registrationsDistributor
43. 43
    LABORATORIOS LICON, S.A.
    68 registrationsMaker's own entity
44. 44
    ASESORES MÉDICO BIOLÓGICOS, S.A. DE C.V.
    68 registrationsRegulatory representative
45. 45
    DRPRO MED S.A. DE C.V.Ciudad de México
    66 registrationsDistributor
46. 46
    MERIT MÉXICO SALES, S. DE R.L. DE C.V.
    65 registrationsMaker's own entity
47. 47
    Arthrex Mexico, S.A. de C.V.Col. Napoles Mexico
    64 registrationsMaker's own entity
48. 48
    DIAGNÓSTICA INTERNACIONAL, S.A. DE C.V.
    64 registrationsMaker's own entity
49. 49
    MÉDICOS, S.A. DE C.V.
    64 registrationsRegulatory representative
50. 50
    DICIPA, S.A. DE C.V.
    62 registrationsRegulatory representative

Download all 2,688 company rows as CSV

Company level only: names that are only a person's name are left out.

How many holders also distribute

9 of the 2,689 holders listed here (under 1%) are also independent distributors in the Index: companies that supply the market for makers other than themselves, not a manufacturer, a maker's own entity or a regulatory service firm.

The others: 896 makers' own import or sales entities, 38 manufacturers and 1,746 regulatory representatives that hold registrations with no sign in the registries that they supply the market.

Holders that also distribute in Mexico: top 9

1. 1
   KABLA COMERCIAL, S.A. DE C.V.Guadalupe, Nuevo Leon
   411 registrationsDistributor
2. 2
   LEVBETH MEDICAL, S.A. DE C.V.Monterrey, Nuevo Leon
   90 registrationsDistributor
3. 3
   CORPORINTER, S.A. DE C.V.Zapopan, Jalisco
   88 registrationsDistributor
4. 4
   MEDSTENT, S.A. DE C.V.
   83 registrationsDistributor
5. 5
   ABALAT, S.A. DE C.V.Ciudad de México
   71 registrationsDistributor
6. 6
   ALEACIONES DENTALES ZEYCO, S.A. DE C.V.Zapopan
   68 registrationsDistributor
7. 7
   DRPRO MED S.A. DE C.V.Ciudad de México
   66 registrationsDistributor
8. 8
   ATYDE MÉXICO, S.A. DE C.V.Naucalpan de Juárez
   60 registrationsDistributor
9. 9
   ARFAMEX, S.A. DE C.V.Ciudad de México
   58 registrationsDistributor

See every independent distributor in Mexico on the country page.

Independent holders in Mexico: top 20

Companies that hold registrations here with no sign in the registries that they supply the market themselves: regulatory representatives and holders as a service. A holder that is not your distributor keeps your distributors replaceable. Confirm what each one does before you appoint it.

1. 1
   ISA HEALTH, S.A. DE C.V.Ciudad de Mexico
   441 registrationsRegulatory representative
2. 2
   EMERGO, S. DE R.L. DE C.V.
   426 registrationsRegulatory representative
3. 3
   QUIMIBIOL, S.A. DE C.V.
   138 registrationsRegulatory representative
4. 4
   SUMINISTRO PARA USO MÉDICO Y HOSPITALARIO, S.A. DE C.V.
   97 registrationsRegulatory representative
5. 5
   REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.
   86 registrationsRegulatory representative
6. 6
   AGUILAR MURGUÍA ASESORES EN SERVICIOS INTEGRALES DE SALUD, S.A. DE C.V.Benito Juarez, Ciudad de Mexico
   82 registrationsRegulatory representative
7. 7
   PROMESURGICAL, S.A. DE C.V.
   79 registrationsRegulatory representative
8. 8
   MANDALA MÉXICO LEGAL AFFAIRS, S.A. DE C.V.
   73 registrationsRegulatory representative
9. 9
   VERAQUE, S. DE R.L. DE C.V.
   70 registrationsRegulatory representative
10. 10
    ASESORES MÉDICO BIOLÓGICOS, S.A. DE C.V.
    68 registrationsRegulatory representative
11. 11
    MÉDICOS, S.A. DE C.V.
    64 registrationsRegulatory representative
12. 12
    DICIPA, S.A. DE C.V.
    62 registrationsRegulatory representative
13. 13
    BIO LEBEN, S.A. DE C.V.
    58 registrationsRegulatory representative
14. 14
    RAFCO SERVICES, S.A. DE C.V.
    57 registrationsRegulatory representative
15. 15
    SURTIDORA MÉDICA DE OCCIDENTE, S.A. DE C.V.
    57 registrationsRegulatory representative
16. 16
    MANOHAY MÉXICO, S.A DE C.V.
    57 registrationsRegulatory representative
17. 17
    BRAYSER S.C.
    54 registrationsRegulatory representative
18. 18
    SJ MEDICAL MÉXICO, S. DE R.L. DE C.V.
    53 registrationsRegulatory representative
19. 19
    AXMILAB, S.A. DE C.V.
    53 registrationsRegulatory representative
20. 20
    ENSAYOS Y TAMIZAJES DE MÉXICO, S.A. DE C.V.
    49 registrationsRegulatory representative

Medical device registration in Mexico with CE or FDA clearance

With CE marking: No reliance route on CE marking is confirmed in the source.

With FDA clearance: FDA clearance opens a shorter reliance route.

COFEPRIS equivalence agreements cover FDA and Health Canada (2010) and Japan (2012) device approvals. A 2025 abbreviated reliance pathway exists; whether it covers CE for devices is not confirmed. A Mexican registration holder is required.

Sources: PAHO/PANDRH, COFEPRIS equivalence agreements for medical devices (FDA and Health Canada 2010, Japan 2012), Diario Oficial de la Federacion, 18 Jul 2025, guidelines for the abbreviated regulatory pathway (reliance on reference authorities). Confidence in this route: medium, checked 23 October 2026. Rules change and differ by device class; confirm with the regulator before you plan a launch date.

How to check it yourself in the official register

COFEPRIS viewer of medical device registrations (Visor de Registros Sanitarios de Dispositivos Médicos). COFEPRIS opened this viewer in August 2026. It lists device registrations, and holders can send corrections for their own records.

The register is the record that counts. Check the holder named on your own device's registration before you sign, and again before you change distributors.

What changes if you switch holder

The registration sits in the holder's name, not yours. If the holder is also your distributor, changing or adding a distributor means moving the registration or filing a new one, and where a regulator publishes a transfer process, the current holder has to take part.

Independent holders, firms that hold registrations for makers without selling their products, keep your distributors replaceable. In the Index, 1,746 of the companies listed here show no sign in the registries that they supply the market themselves, which is a place to start looking; confirm what each one does before you appoint it.

The article Who holds the registration compares holding it yourself, through an independent holder or through your distributor, and lists the clauses to agree before the first order.

Next step

All guides

Sources

• Mexico COFEPRIS medical device registrations (registros sanitarios): 2,689 establishments, last seen 23 October 2026. Mexican government publication.
• US FDA Establishment Registration and Device Listing, openFDA bulk download: 46 establishments, last seen 23 October 2026. US government work, public domain.
• Health Canada MDALL active licence listing and MDEL establishment licence listing: 3 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.
• Company website (the establishment's own public site): 15 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.

Index build 25 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.