Updated 23 October 2026

Patient monitoring and neurology device distributors in Brazil: 479 licensed establishments

The Bastion Hale Distributor Index lists 479 establishments in Brazil whose registry records include patient monitoring and neurology: 177 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 280 manufacturers' own import or sales entities, 7 regulatory representatives, and 15 manufacturers or exporters, out of 4,256 medical device establishments in Brazil overall. The records come from ANVISA Brazil, US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 October 2026.

479establishments
177independent distributors
280makers' own sales entities
15manufacturers only

Entry decision: patient monitoring and neurology (MONI) in Brazil

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

Go next Rank 33 of 112 markets for this maker.

Held back: ANVISA notification still needs a Brazil Registration Holder, and class III and IV devices need full registration; about 57% collected at the border, about 20% real after credits.

High confidence: official registry with device categories and 177 independent distributors confirmed in MONI; registration route from the regulator's published rules.

FDA cleared, shipping from the US

Go next Rank 6 of 112 markets for this maker.

Held back: ANVISA notification still needs a Brazil Registration Holder, and class III and IV devices need full registration; about 57% collected at the border, about 20% real after credits.

High confidence: official registry with device categories and 177 independent distributors confirmed in MONI; registration route from the regulator's published rules.

Registration route

With CE marking: Brazil notifies class I and II devices instead of registering them. High confidence.

With FDA clearance: Brazil notifies class I and II devices instead of registering them. High confidence.

A local holder or authorised representative must hold or file the registration. Who holds the registration

ANVISA optimised route for class III and IV relies on FDA, Health Canada, TGA and Japan decisions; the EU is not on the device list. Brazil Registration Holder, BGMP and INMETRO still apply.

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: ANVISA Instrucao Normativa 290/2024, optimised device registration based on an equivalent..., ANVISA RDC 751/2022 (English), Articles 6 and 7, ANVISA RDC 830/2023 on IVDs (English), Articles 6 and 7.

Sales channel

Distributor-led: Foreign makers sell through distributors here. A Brazil Registration Holder and a local importer or distributor are mandatory; distributor networks by state.

US Commercial Service country guide, published 21 August 2025.

Independent distributors in the Index: 177 for patient monitoring and neurology, 1,407 in Brazil overall.

Makers registered here: 280 makers' own import or sales entities and 15 manufacturers.

Landed cost

Landed cost from the EU: about 57% collected at the border, about 20% real after credits (medium confidence, confirm with a customs broker). Duty about 12%, import VAT or GST about 18%.

Landed cost from the US: about 57% collected at the border, about 20% real after credits (medium confidence, confirm with a customs broker). Duty about 12%, import VAT or GST about 18%.

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 076, MFN applied, HS6, ITA Country Commercial Guide: Brazil Import Tariffs (last published 2025-08-21).

Market size

Health spending: USD 213bn in 2023, USD 1,010 per person (World Bank).

Patient monitoring and neurology (TAM): about USD 450m to 1.3bn a year (estimate, low confidence).

For one product line sold through distributors: SAM about USD 37m to 170m, SOM about USD 110k to 690k 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 4,250 establishments, the 1,405 independent distributors first. Company records only. 6 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.

Top 20 independent patient monitoring and neurology distributors

Independent distributors only, ranked by the lines each distributor carries for other manufacturers, then registrations held, then size.

  1. 1
    159 lines654 registrationssize 86.9
  2. 2
    141 lines855 registrationssize 89.8
  3. 3
    69 lines186 registrationssize 79.8
  4. 4
    66 lines402 registrationssize 86.5
  5. 5
    65 lines161 registrationssize 79.5
  6. 6
    64 lines633 registrationssize 86.6
  7. 7
    51 lines136 registrationssize 76.7
  8. 8
    42 lines152 registrationssize 77.4
  9. 9
    39 lines191 registrationssize 81.0
  10. 10
    39 lines173 registrationssize 80.0
  11. 11
    35 lines78 registrationssize 72.7
  12. 12
    33 lines139 registrationssize 77.0
  13. 13
    H STRATTNER E CIA LTDARio De Janeiro, RJ
    32 lines171 registrationssize 80.3
  14. 14
    32 lines77 registrationssize 70.3
  15. 15
    31 lines123 registrationssize 74.9
  16. 16
    CMS PRODUTOS HOSPITALARES LTDAAparecida De Goiânia, GO
    31 lines121 registrationssize 77.8
  17. 17
    28 lines160 registrationssize 76.7
  18. 18
    27 lines92 registrationssize 71.8
  19. 19
    CEDRS - GESTAO EMPRESARIAL LTDASão Bernardo Do Campo, SP
    26 lines280 registrationssize 80.0
  20. 20
    26 lines77 registrationssize 71.8
Include manufacturers, their own sales entities and regulatory representatives (302)

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.

  1. 1
    78 lines219 registrationssize 83.4
  2. 2
    77 lines965 registrationssize 89.8
  3. 3
    68 lines299 registrationssize 84.6
  4. 4
    GRUPO MULTILASER S.A.São Paulo, SP
    63 lines137 registrationssize 76.8
  5. 5
    48 lines293 registrationssize 85.5
  6. 6
    46 lines165 registrationssize 80.4
  7. 7
    40 lines83 registrationssize 72.9
  8. 8
    LABORATORIOS B. BRAUN S/ASão Gonçalo, RJ
    38 lines522 registrationssize 88.9
  9. 9
    36 lines83 registrationssize 73.2
  10. 10
    30 lines71 registrationssize 70.2
  11. 11
    26 lines418 registrationssize 87.4
  12. 12
    23 lines633 registrationssize 89.5
  13. 13
    20 lines1,282 registrationssize 90.8
  14. 14
    20 lines151 registrationssize 75.0
  15. 15
    20 lines120 registrationssize 76.8
  16. 16
    20 lines117 registrationssize 73.2
  17. 17
    19 lines994 registrationssize 89.1
  18. 18
    18 lines111 registrationssize 74.9
  19. 19
    MOBIL SAÚDE COMERCIAL LTDASão Caetano Do Sul, SP
    18 lines43 registrationssize 62.5
  20. 20
    17 lines474 registrationssize 84.9

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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

RoleEstablishmentsShareWhat it means
Importer41987%Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence.
Distributor43691%Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH).
Registration holder47299%Holds device licences or registrations in its own name (Health Canada MDALL licence holder).
Manufacturer24050%Registered as a manufacturer with an address in this market, including foreign registrations.
Exporter22848%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 Brazil

In Brazil the ANVISA registration is held by a Brazilian Registration Holder (BRH). If the distributor is the BRH, it owns the registration; an independent holder lets you appoint and replace distributors under it.

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 Brazil

How many patient monitoring and neurology distributors are there in Brazil?

The Index counts 479 establishments in Brazil with patient monitoring and neurology in their registry record, of which 177 are independent distributors (a channel role and no manufacturing of their own). The number comes from ANVISA Brazil, US FDA (openFDA), MHRA UK and Health Canada and was last refreshed on 23 October 2026.

Who can hold a patient monitoring and neurology device registration in Brazil?

In Brazil the ANVISA registration is held by a Brazilian Registration Holder (BRH). If the distributor is the BRH, it owns the registration; an independent holder lets you appoint and replace distributors under it.

How do I find a patient monitoring and neurology distributor in Brazil?

Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Brazil 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 Brazil?

A company that appears in a public regulatory registry with an address in Brazil 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 Brazil?

With CE marking: Brazil notifies class I and II devices instead of registering them. With FDA clearance: Brazil notifies class I and II devices instead of registering them. A local holder or authorised representative must hold or file the registration. ANVISA optimised route for class III and IV relies on FDA, Health Canada, TGA and Japan decisions; the EU is not on the device list. Brazil Registration Holder, BGMP and INMETRO still apply. Confirm with a regulatory specialist before you plan a launch date.

How big is the patient monitoring and neurology market in Brazil?

Health spending in Brazil was USD 213bn in 2023 (World Bank). Bastion Hale estimates the patient monitoring and neurology market at about USD 450m to 1.3bn 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 Brazil

Patient monitoring and neurology in other Latin America and the Caribbean markets

Sources

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.