Medical device distributors in Latin America: 7,435 licensed establishments in 23 markets

Medical device distributors in Latin America by country

Every market in Latin America with a licensed establishment in the Index, the most independent distributors first. Importers and holders (registration holders, authorised representatives and sponsors) count every establishment with that role, independent or not. Total counts every licensed establishment.

Top 20 medical device distributors in Latin America

Independent distributors only, ranked by the other manufacturers' lines each carries or represents in the registries, then registrations held, then size score. Not a ranking by revenue: the registries publish none.

1. 1
   CIRURGICA FERNANDES - COMERCIO DE MATERIAIS CIRURGICOS E HOSPITALARES - SOCIEDADE LIMITADASantana De Parnaíba, Brazil
   153 lines654 registrationsSize score 87 of 100
2. 2
   PASSROD IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS PARA SAÚDE LTDA - MERibeirão Preto, Brazil
   140 lines855 registrationsSize score 90 of 100
3. 3
   MEDIX BRASIL LTDACascavel, Brazil
   96 lines373 registrationsSize score 85 of 100
4. 4
   NUTRIEX IMPORTACAO E EXPORTACAO DE PRODUTOS NUTRICIONAIS E FARMOQUIMICOS LTDAAparecida De Goiânia, Brazil
   79 lines248 registrationsSize score 84 of 100
5. 5
   LABOR IMPORT COMERCIAL IMPORTADORA E EXPORTADORA LTDAOsasco, Brazil
   74 lines219 registrationsSize score 83 of 100
6. 6
   MANDALA BRASIL IMPORTACAO E DISTRIBUICAO DE PRODUTO MEDICO HOSPITALAR LTDAMaringá, Brazil
   65 lines402 registrationsSize score 86 of 100
7. 7
   BIOMÉDICA EQUIPAMENTOS E SUPRIMENTOS HOSPITALARES LTDABrasília, Brazil
   65 lines299 registrationsSize score 85 of 100
8. 8
   MONTSERRAT COMERCIAL IMPORTADORA E EXPORTADORA LTDASão Bernardo Do Campo, Brazil
   62 lines161 registrationsSize score 80 of 100
9. 9
   GRUPO MULTILASER S.A.São Paulo, Brazil
   62 lines137 registrationsSize score 77 of 100
10. 10
    JOÃOMED COMÉRCIO DE MATERIAIS CIRÚRGICOS S/ACuritiba, Brazil
    61 lines186 registrationsSize score 80 of 100
11. 11
    ARGOSLAB DISTRIBUIDORA DE PRODUTOS PARA LABORATÓRIOS LTDASão Paulo, Brazil
    59 lines633 registrationsSize score 87 of 100
12. 12
    CRAL ARTIGOS PARA LABORATORIO LTDACotia, Brazil
    56 lines240 registrationsSize score 84 of 100
13. 13
    BECARE COMÉRCIO DE PRODUTOS MÉDICO HOSPITALARES LTDA EPPSão Paulo, Brazil
    51 lines136 registrationsSize score 77 of 100
14. 14
    HTS - TECNOLOGIA EM SAÚDE, COMÉRCIO, IMPORTAÇÃO E EXPORTAÇÃO LTDALagoa Santa, Brazil
    50 lines222 registrationsSize score 84 of 100
15. 15
    CEI COMÉRCIO EXPORTAÇÃO E IMPORTAÇÃO DE MATERIAIS MÉDICOS LTDAAnápolis, Brazil
    46 lines293 registrationsSize score 85 of 100
16. 16
    CML- Centro Médico Logístico LtdaSão Paulo, Brazil
    45 lines165 registrationsSize score 80 of 100
17. 17
    PURE LATAM BRAZIL COMERCIO DE PRODUTOS HOSPITALARES LTDASão Paulo, Brazil
    42 lines152 registrationsSize score 77 of 100
18. 18
    SUPERMED COMERCIO E IMPORTACAO DE PRODUTOS MEDICOS E HOSPITALARES LTDACambuí, Brazil
    40 lines110 registrationsSize score 74 of 100
19. 19
    LINE LIFE CARDIOVASCULAR COM DE PROD MED E HOSP LTDASão Paulo, Brazil
    38 lines173 registrationsSize score 80 of 100
20. 20
    MEDMAX COMÉRCIO DE EQUIPAMENTOS MÉDICOS E SIMILARES LTDA- MESanta Rita Do Sapucaí, Brazil
    36 lines191 registrationsSize score 80 of 100

Segments in Latin America

Establishments in Latin America whose registry records include each segment (total), the independent distributors among them, and the country pages for the segment; a company can appear in several segments. Each segment links to its page for every market.

Medical device registration in Latin America, country by country

One line per registration rule, for the markets where a public source confirms it. Each country page has the full rule.

• Argentina: Class I and II devices authorised in a reference country (EU, EFTA, US, UK, Australia, Japan, Israel) need only a notification with a free sale certificate; class III and IV follow the full ANMAT route. Sources: Argentina government note, 6 Feb 2026: ANMAT Disposition 236/2026 under Decree 892/2025.
• Brazil: 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. Who holds registrations there: the list. Sources: ANVISA Instrucao Normativa 290/2024, optimised device registration based on an equivalent....
• Mexico: 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. Who holds registrations there: the list. Sources: PAHO/PANDRH, COFEPRIS equivalence agreements for medical devices.
• Peru: Registration with DIGEMID through a local distributor; reliance on high surveillance countries not verified for devices. Sources: US Commercial Service country guide.
• Puerto Rico: US territory under FDA rules. Sources: US FDA, Overview of device regulation.
• Uruguay: Registration through a local company; FDA approval alone is not sufficient. Sources: US Commercial Service country guide.

Who should hold the registration, and how a transfer works

General information, not legal advice. Local law varies; take local counsel.

Next steps

All guides

Other regions

Every market by region

Sources

• Brazil ANVISA medical device registrations, open data portal: 4,205 establishments, last seen 23 October 2026. Brazilian government open data.
• Mexico COFEPRIS medical device registrations (registros sanitarios): 2,694 establishments, last seen 23 October 2026. Mexican government publication.
• US FDA Establishment Registration and Device Listing, openFDA bulk download: 637 establishments, last seen 23 October 2026. US government work, public domain.
• UK MHRA Public Access Registration Database (PARD): 22 establishments, last seen 23 October 2026. Public register.
• Health Canada MDALL active licence listing and MDEL establishment licence listing: 19 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
• Company website (the establishment's own public site): 33 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.