Registry Insights · COFEPRIS
Mexico Medical Device Registry Statistics
Aggregated from 13,216 official COFEPRIS registration records covering 4,690 manufacturers. Data as of 2024-07-16.
The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) regulates medical devices in Mexico. As of 2024-07-16, this registry snapshot contains 13,216 registration records.
The largest manufacturer by registrations is ABBOTT LABORATORIES DE MÉXICO, S.A. DE C.V. with 209 registrations.
Every figure on this page is computed from the official registry snapshot. Browse individual records in the searchable Mexico device database, or see our methodology for how the data is collected.
13,216
Registrations
4,690
Manufacturers
Registrations by Risk Class
COFEPRIS risk classification of registrations
| Risk class | Registrations | Share |
|---|---|---|
| Class I | 4,909 | 37.1% |
| Class II | 4,614 | 34.9% |
| Class III | 2,139 | 16.2% |
| Class I (low risk) | 1,554 | 11.8% |
New Registrations by Year
Registrations issued per year
| Year | New registrations |
|---|---|
| 2024 | 1,963 |
| 2023 | 5 |
| 2022 | 2,357 |
| 2021 | 2,209 |
| 2020 | 1,657 |
| 2019 | 2,275 |
| 2018 | 2,747 |
Registrations by Product Type
Largest product type groups among registrations
| Product Type | Registrations | Share |
|---|---|---|
| I. Medical Equipment | 3,598 | 27.2% |
| V. Surgical And Healing Materials | 2,770 | 21.0% |
| Iii. Diagnostic Agents | 2,770 | 21.0% |
| III. Diagnostic Agents | 1,255 | 9.5% |
| Ii. Prosthetics, Orthoses And Functional Aids | 895 | 6.8% |
| V. Surgical and Healing Materials | 685 | 5.2% |
| Iv. Dental Supplies | 391 | 3.0% |
| Vi. Hygienic Products | 289 | 2.2% |
| II. Protesis, órtesis y ayudas funcionales | 282 | 2.1% |
| IV. Dental Supplies | 126 | 1.0% |
| VI. Hygiene Products | 91 | 0.7% |
| Ii.Prostheses, Orthoses And Functional Aids | 39 | 0.3% |
| Ii. Prostheses, Orthoses And Functional Aids | 23 | 0.2% |
Top 50 Manufacturers in Mexico
Ranked by registrations. Company names are normalized; affiliated legal entities are listed separately, as registered.
| Rank | Manufacturer | Registrations | Top categories |
|---|---|---|---|
#1 | ABBOTT LABORATORIES DE MÉXICO, S.A. DE C.V. | 209 | Iii. Diagnostic Agents III. Diagnostic Agents I. Medical Equipment |
#2 | ISA HEALTH, S.A. DE C.V. | 164 | V. Surgical And Healing Materials I. Medical Equipment |
#3 | PRODUCTOS ROCHE, S.A. DE C.V. | 156 | Iii. Diagnostic Agents III. Diagnostic Agents I. Medical Equipment |
#4 | EMERGO, S. DE R.L. DE C.V. | 153 | I. Medical Equipment V. Surgical And Healing Materials Ii. Prosthetics, Orthoses And Functional Aids |
#5 | KABLA COMERCIAL, S.A. DE C.V. | 153 | III. Diagnostic Agents Iii. Diagnostic Agents I. Medical Equipment |
#6 | SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V. | 125 | Iii. Diagnostic Agents III. Diagnostic Agents I. Medical Equipment |
#7 | ABBOTT LABORATORIES DEMÉXICO, S.A. DE C.V. | 99 | Iii. Diagnostic Agents I. Medical Equipment Ii. Prosthetics, Orthoses And Functional Aids |
#8 | I.L. DIAGNOSTICS, S.A. DE C.V. | 90 | Iii. Diagnostic Agents III. Diagnostic Agents I. Medical Equipment |
#9 | DEGASA, S.A. DE C.V. | 89 | V. Surgical And Healing Materials V. Surgical and Healing Materials VI. Hygiene Products |
#10 | INOCHEM, S.A. DE C.V. | 89 | III. Diagnostic Agents Iii. Diagnostic Agents I. Medical Equipment |
#11 | GRIFOLS MÉXICO, S.A. DE C.V. | 73 | Iii. Diagnostic Agents III. Diagnostic Agents I. Medical Equipment |
#12 | BECKMAN COULTER DE MÉXICO, S.A. DE C.V. | 72 | III. Diagnostic Agents Iii. Diagnostic Agents I. Medical Equipment |
#13 | INSUMOS PARA LA SALUD, S.A. DE C.V. | 69 | III. Diagnostic Agents Iii. Diagnostic Agents I. Medical Equipment |
#14 | BIOMET MÉXICO, S.A. DE C.V. | 67 | I. Medical Equipment Ii. Prosthetics, Orthoses And Functional Aids |
#15 | REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V. | 55 | Iii. Diagnostic Agents III. Diagnostic Agents I. Medical Equipment |
#16 | JOHNSON & JOHNSON DE MÉXICO, S.A. DE C.V. | 53 | Ii. Prosthetics, Orthoses And Functional Aids I. Medical Equipment |
#17 | MINDRAY MEDICAL MÉXICO, S. DE R.L. DE C.V. | 52 | Iii. Diagnostic Agents III. Diagnostic Agents I. Medical Equipment |
#18 | SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V. | 50 | Iii. Diagnostic Agents I. Medical Equipment III. Diagnostic Agents |
#19 | SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V. | 49 | III. Diagnostic Agents Iii. Diagnostic Agents I. Medical Equipment |
#20 | MEDTRONIC, S. DE R.L. DE C.V. | 45 | V. Surgical And Healing Materials I. Medical Equipment Ii. Prosthetics, Orthoses And Functional Aids |
#21 | INOCHEM S.A. DE C.V. | 44 | Iii. Diagnostic Agents III. Diagnostic Agents I. Medical Equipment |
#22 | BECTON DICKINSON DE MÉXICO, S.A. DE C.V. | 43 | III. Diagnostic Agents Iii. Diagnostic Agents V. Surgical and Healing Materials |
#23 | BOSTON SCIENTIFIC DE MÉXICO, S.A. DE C.V. | 42 | V. Surgical And Healing Materials Ii. Prosthetics, Orthoses And Functional Aids V. Surgical and Healing Materials |
#24 | DICIPA, S.A. DE C.V. | 42 | Iii. Diagnostic Agents I. Medical Equipment III. Diagnostic Agents |
#25 | MEDSTENT, S.A. DE C.V. | 41 | V. Surgical And Healing Materials I. Medical Equipment Ii. Prosthetics, Orthoses And Functional Aids |
#26 | QUIMIBIOL, S.A. DE C.V. | 41 | III. Diagnostic Agents Iii. Diagnostic Agents I. Medical Equipment |
#27 | DIASORIN MÉXICO S.A. DE C.V. | 38 | Iii. Diagnostic Agents I. Medical Equipment |
#28 | ABALAT, S.A. DE C.V. | 37 | III. Diagnostic Agents Iii. Diagnostic Agents I. Medical Equipment |
#29 | ABBOTTLABORATORIES DEMÉXICO, S.A. DE C.V. | 37 | Iii. Diagnostic Agents I. Medical Equipment |
#30 | MEDLINE MÉXICO, S. DE R.L. DE C.V. | 37 | V. Surgical And Healing Materials V. Surgical and Healing Materials I. Medical Equipment |
#31 | SMITH & NEPHEW, S.A. DE C.V. | 37 | II. Protesis, órtesis y ayudas funcionales V. Surgical And Healing Materials V. Surgical and Healing Materials |
#32 | AGUILAR MURGUÍA ASESORES EN SERVICIOS INTEGRALES DE SALUD, S.A. DE C.V. | 36 | I. Medical Equipment V. Surgical and Healing Materials |
#33 | EMERGO S. DE R.L. DE C.V. | 36 | V. Surgical And Healing Materials I. Medical Equipment |
#34 | AXMILAB, S.A. DE C.V. | 35 | Iii. Diagnostic Agents III. Diagnostic Agents I. Medical Equipment |
#35 | STRYKER MÉXICO, S.A. DE C.V. | 35 | I. Medical Equipment V. Surgical And Healing Materials |
#36 | BIO SIMEX, S.A. DE C.V. | 34 | Iii. Diagnostic Agents III. Diagnostic Agents I. Medical Equipment |
#37 | ISA HEALTH S.A. DE C.V. | 32 | I. Medical Equipment Ii. Prosthetics, Orthoses And Functional Aids Iii. Diagnostic Agents |
#38 | LABORATORIOS LICON, S.A. | 31 | Iii. Diagnostic Agents I. Medical Equipment III. Diagnostic Agents |
#39 | MANDALA MÉXICO LEGAL AFFAIRS, S.A. DE C.V. | 31 | I. Medical Equipment Ii. Prosthetics, Orthoses And Functional Aids III. Diagnostic Agents |
#40 | CORPORINTER, S.A. DE C.V. | 30 | III. Diagnostic Agents V. Surgical and Healing Materials I. Medical Equipment |
#41 | LEVBETH MEDICAL, S.A. DE C.V. | 30 | V. Surgical and Healing Materials V. Surgical And Healing Materials Ii. Prosthetics, Orthoses And Functional Aids |
#42 | SIEMENS HEALTHCARE DIAGNOSTICS S DE RL DE CV | 30 | Iii. Diagnostic Agents I. Medical Equipment III. Diagnostic Agents |
#43 | 3M MÉXICO, S.A. DE C.V. | 29 | V. Surgical And Healing Materials IV. Dental Supplies V. Surgical and Healing Materials |
#44 | AUXEIN MÉXICO, S.A. DE C.V. | 29 | I. Medical Equipment II. Protesis, órtesis y ayudas funcionales V. Surgical and Healing Materials |
#45 | GE SISTEMAS MÉDICOS DE MÉXICO, S.A. DE C.V. | 28 | I. Medical Equipment Iii. Diagnostic Agents |
#46 | KANA UNDESA, S.A. DE C.V. | 27 | III. Diagnostic Agents Iii. Diagnostic Agents I. Medical Equipment |
#47 | VAMASA, S.A. DE C.V. | 27 | IV. Dental Supplies Iv. Dental Supplies I. Medical Equipment |
#48 | BIO-RAD, S.A. | 26 | Iii. Diagnostic Agents I. Medical Equipment III. Diagnostic Agents |
#49 | PROMESURGICAL, S.A. DE C.V. | 25 | V. Surgical And Healing Materials II. Protesis, órtesis y ayudas funcionales V. Surgical and Healing Materials |
#50 | DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V. | 24 | Iii. Diagnostic Agents III. Diagnostic Agents I. Medical Equipment |
About this data: statistics are computed from the official Comisión Federal para la Protección contra Riesgos Sanitarios registry as mirrored in the Pure Global database (13,216 records, newest registration dated 2024-07-16; page generated 2026-08-05). Company names are normalized for whitespace and case, but distinct legal entities of the same group are counted separately. See methodology.