Updated 23 October 2026
Patient monitoring and neurology device distributors in Mexico: 419 licensed establishments
Mexico has 4 independent distributors in the Index so far.
The Bastion Hale Distributor Index lists 419 establishments in Mexico whose registry records include patient monitoring and neurology: 4 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 139 manufacturers' own import or sales entities, 188 regulatory representatives, and 88 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.
Entry decision: patient monitoring and neurology (MONI) in Mexico
For a typical maker, from public data and the free Market Finder. Your own clearance, device class and current markets change the answer.
CE marked, shipping from the EU
Not now Rank 82 of 112 markets for this maker.
Held back: FDA clearance needed first; CE marking is not accepted here; the Index has only 9 independent distributor records here so far.
Medium confidence: registration route only partly confirmed in official sources.
FDA cleared, shipping from the US
Go next Rank 20 of 112 markets for this maker.
Held back: the Index has only 9 independent distributor records here so far.
Medium confidence: registration route only partly confirmed in official sources.
Registration route
With CE marking: FDA clearance needed first; CE marking is not accepted here. Medium confidence.
With FDA clearance: FDA opens a shorter reliance route. Medium confidence.
A local holder or authorised representative must hold or file the registration. Who holds the registration
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.
Timeline and fees are not shown: no official source we cite gives them for this market yet. Confirm with a regulatory specialist before you plan a launch date. Sources: PAHO/PANDRH, COFEPRIS equivalence agreements for medical devices, Diario Oficial de la Federacion, 18 Jul 2025, guidelines for the abbreviated regulatory....
Sales channel
Distributor-led: Foreign makers sell through distributors here. A Mexican Registration Holder is needed and the distributor must hold a COFEPRIS import licence; private hospitals and IMSS tenders.
US Commercial Service country guide, published 17 February 2026.
Independent distributors in the Index: 4 for patient monitoring and neurology, 9 in Mexico overall.
Makers registered here: 139 makers' own import or sales entities and 88 manufacturers.
Landed cost
Landed cost from the EU: about 17% collected at the border, about 1% real after credits (medium confidence, confirm with a customs broker). No duty, import VAT or GST about 16%.
Landed cost from the US: about 17% collected at the border, about 1% real after credits (medium confidence, confirm with a customs broker). No duty, import VAT or GST about 16%.
Tariff basket: patient monitoring and neurology. Cash is collected at clearance. Real cost is what stays after a registered distributor recovers VAT and charges. Sources: World Bank WITS TRAINS tariff API, reporter 484, MFN applied, HS6, ITA Country Commercial Guide: Mexico Import Tariffs (last published 2026-02-09).
Market size
Health spending: USD 98.7bn in 2023, USD 761 per person (World Bank).
Patient monitoring and neurology (TAM): about USD 410m to 980m a year (estimate, low confidence).
For one product line sold through distributors: SAM about USD 32m to 120m, SOM about USD 92k to 520k a year (estimate). The free Market Finder sizes your own product range.
Broad scope, as in MedTech Europe figures: devices, diagnostics and consumables at manufacturer prices. Narrower published figures are lower.
How we estimate. At manufacturer prices.
Next step
The finder ranks every market for your own device, clearance and current markets. The CSV lists 2,945 establishments, the 9 independent distributors first. Company records only. 19 rows are not in the CSV and stay on their profile pages, for example names of a person or records whose only source is the Health Canada licence list.
Listed
Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.
- 1KABLA COMERCIAL, S.A. DE C.V.Guadalupe, Nuevo Leon34 lines411 registrationssize 81.0
- 2LEVBETH MEDICAL, S.A. DE C.V.Monterrey, Nuevo Leon21 lines90 registrationssize 67.8
- 3DRPRO MED S.A. DE C.V.Ciudad de México11 lines66 registrationssize 62.5
- 40 lines83 registrationssize 55.3
Include manufacturers, their own sales entities and regulatory representatives (410)
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
- 2INOCHEM, S.A. DE C.V.Tlalpan, Ciudad de Mexico0 lines303 registrationssize 63.6
- 30 lines254 registrationssize 62.7
- 40 lines181 registrationssize 60.6
- 5I.L. DIAGNOSTICS, S.A. DE C.V.Miguel Hidalgo, Ciudad de Mexico0 lines174 registrationssize 60.2
- 60 lines161 registrationssize 59.4
- 70 lines161 registrationssize 59.4
- 8BIOMET MÉXICO, S.A. DE C.V.Mexico City Ciudad de Mexico0 lines143 registrationssize 63.9
- 90 lines138 registrationssize 57.9
- 100 lines120 registrationssize 56.6
- 110 lines117 registrationssize 56.3
- 120 lines116 registrationssize 56.2
- 130 lines109 registrationssize 55.6
- 140 lines104 registrationssize 55.2
- 150 lines100 registrationssize 54.8
- 160 lines97 registrationssize 54.5
- 170 lines86 registrationssize 53.3
- 180 lines76 registrationssize 52.2
- 190 lines73 registrationssize 51.8
- 200 lines71 registrationssize 51.5
See Brazil: 1,407 independent distributors
Distributor in Mexico? Add your company, free
Patient monitoring, neurology and physical medicine covers monitors, pulse oximetry, EEG and EMG, rehabilitation and wearable devices. Registries group a wide range of risk classes here, so the counts include both hospital capital equipment houses and consumer-grade device importers. Software and connectivity now feature in many registrations.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 5 | 1% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 341 | 81% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 86 | 21% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 18 | 4% | 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 patient monitoring and neurology distributors in Mexico
How many patient monitoring and neurology distributors are there in Mexico?
The Index counts 419 establishments in Mexico with patient monitoring and neurology in their registry record, of which 4 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 a patient monitoring and neurology 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 patient monitoring and neurology 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 names, free, no sign-up. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as a patient monitoring and neurology 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 patient monitoring and neurology segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
How are CE-marked and FDA-cleared patient monitoring and neurology devices registered in Mexico?
With CE marking: FDA clearance needed first; CE marking is not accepted here. With FDA clearance: FDA opens a shorter reliance route. A local holder or authorised representative must hold or file the registration. 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. Confirm with a regulatory specialist before you plan a launch date.
How big is the patient monitoring and neurology market in Mexico?
Health spending in Mexico was USD 98.7bn in 2023 (World Bank). Bastion Hale estimates the patient monitoring and neurology market at about USD 410m to 980m a year at manufacturer prices. This is a model estimate with low confidence: health spending times the device share of health spending times the segment's share of world medical technology spending. The methodology page shows every input and source.
Other segments in Mexico
Patient monitoring and neurology in other Latin America and the Caribbean markets
Sources
- Mexico COFEPRIS medical device registrations (registros sanitarios): 341 establishments, last seen 23 October 2026. Mexican government publication.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 91 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): 9 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
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.