Updated 25 October 2026
Who holds medical device registrations in Brazil
ANVISA issues a device registration or notification to a holder: a legal entity, either the manufacturer or an importer, that is responsible for the device in Brazil. The Index lists 4,204 ANVISA registration holders in Brazil from the ANVISA Brazil register, last read on 23 October 2026.
Medical device companies in Brazil: distributors, importers and makers
General information, not legal advice. Local law varies; take local counsel.
Who may hold a registration in Brazil
ANVISA issues a device registration or notification to a holder: a legal entity, either the manufacturer or an importer, that is responsible for the device in Brazil.
The local term is detentor do registro.
Sources: ANVISA RDC 751/2022 (English), Article 2.
ANVISA registration holders in Brazil: top 50
Ranked by valid ANVISA registrations. Each name opens its profile with roles, principals and sources.
- 12,387 registrationsRegulatory representative
- 2SIEMENS HEALTHCARE DIAGNÓSTICOS LTDASão Paulo, SP1,282 registrationsMaker's own entity
- 3ROCHE DIAGNÓSTICA BRASIL LTDASão Paulo, SP994 registrationsMaker's own entity
- 4AUTO SUTURE DO BRASIL LTDA.São Paulo, SP965 registrationsMaker's own entity
- 5ABBOTT LABORATORIOS DO BRASIL LTDASão Paulo, SP897 registrationsMaker's own entity
- 6PASSROD IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS PARA SAÚDE LTDA - MERibeirão Preto, SP855 registrationsDistributor
- 7697 registrationsRegulatory representative
- 8CIRURGICA FERNANDES - COMERCIO DE MATERIAIS CIRURGICOS E HOSPITALARES - SOCIEDADE LIMITADASantana De Parnaíba, SP654 registrationsDistributor
- 9VYTTRA DIAGNOSTICOS S.A.São Paulo, SP636 registrationsDistributor
- 10633 registrationsDistributor
- 11STRYKER DO BRASIL LTDASão Paulo, SP633 registrationsMaker's own entity
- 12JOHNSON & JOHNSON DO BRASIL INDUSTRIA E COMERCIO DE PRODUTOS PARA SAUDE LTDAGuarulhos Sao Paulo, SP588 registrationsMaker's own entity
- 13586 registrationsRegulatory representative
- 14LABORATORIOS B. BRAUN S/ASão Gonçalo, RJ522 registrationsMaker's own entity
- 15JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A.Curitiba Parana, PR488 registrationsMaker's own entity
- 16474 registrationsMaker's own entity
- 17Enzytec Biotecnologia Ltda.Belo Horizonte, MG470 registrationsDistributor
- 18MARDEN MEDICAL LTDASão Carlos, SP439 registrationsMaker's own entity
- 19MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDAVargem Grande Paulista, SP423 registrationsRegulatory representative
- 20BOSTON SCIENTIFIC DO BRASIL LTDASão Paulo, SP418 registrationsMaker's own entity
- 21409 registrationsMaker's own entity
- 22402 registrationsDistributor
- 23MEDIX BRASIL LTDACascavel, PR373 registrationsDistributor
- 24Smith & Nephew Comércio de Produtos Médicos Ltda.São Paulo, SP369 registrationsMaker's own entity
- 25E-MED PRODUTOS MÉDICO-HOSPITALARES LTDA - MEVargem Grande Paulista, SP356 registrationsMaker's own entity
- 26ZIMMER BIOMET BRASIL LTDASão Paulo, SP342 registrationsMaker's own entity
- 27PHADIA DIAGNOSTICOS LTDASão Paulo, SP339 registrationsMaker's own entity
- 28IN VITRO DIAGNOSTICA LTDAItabira, MG339 registrationsMaker's own entity
- 29WINNER INDUSTRIA DE DESCARTAVEIS LTDABrasília, DF333 registrationsMaker's own entity
- 30BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.Juiz DE Fora Minas Gerais, MG324 registrationsMaker's own entity
- 31BIOSYS LTDANiterói, RJ319 registrationsDistributor
- 32EUROIMMUN BRASIL MEDICINA DIAGNOSTICA LTDASão Caetano Do Sul, SP315 registrationsMaker's own entity
- 33QUIBASA - QUIMICA BASICA LTDABelo Horizonte, MG312 registrationsDistributor
- 34WERFEN MEDICAL LTDABarueri, SP300 registrationsDistributor
- 35300 registrationsDistributor
- 36299 registrationsDistributor
- 37293 registrationsDistributor
- 38LABTEST DIAGNOSTICA S/ALagoa Santa, MG281 registrationsDistributor
- 39CEDRS - GESTAO EMPRESARIAL LTDASão Bernardo Do Campo, SP280 registrationsDistributor
- 40275 registrationsMaker's own entity
- 41DESCARPACK DESCARTAVEIS DO BRASIL LTDASão Paulo, SP273 registrationsMaker's own entity
- 42LABORLAB PRODUTOS PARA LABORATÓRIOS LTDA EPPGuarulhos, SP266 registrationsDistributor
- 43CIENLABOR INDUSTRIA E COMERCIO LTDAJoão Pessoa, PB264 registrationsMaker's own entity
- 44Eco Diagnóstica LtdaNova Lima, MG257 registrationsMaker's own entity
- 45NUTRIEX IMPORTACAO E EXPORTACAO DE PRODUTOS NUTRICIONAIS E FARMOQUIMICOS LTDAAparecida De, Goiânia248 registrationsDistributor
- 46Domo Salute Consultoria Regulatória LtdaPorto Alegre, RS242 registrationsRegulatory representative
- 47CRAL ARTIGOS PARA LABORATORIO LTDACotia, SP240 registrationsDistributor
- 48Vida Biotecnologia Ltda - MEBelo Horizonte, MG239 registrationsDistributor
- 49SEBIA IMPORTAÇÕES COMERCIALIZAÇÃO E DISTRIBUIÇÃO DE APARELHOS E REATIVOS PARA DIAGNÓSTICO IN VITRO LTDA.São Paulo, SP239 registrationsMaker's own entity
- 50St. Jude Medical Brasil Ltda.Belo Horizonte Minas Gerais, SP237 registrationsMaker's own entity
Download all 4,202 company rows as CSV
Company level only: names that are only a person's name are left out.
How many holders also distribute
1,329 of the 4,204 holders listed here (32%) 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: 2,722 makers' own import or sales entities, 120 manufacturers and 33 regulatory representatives that hold registrations with no sign in the registries that they supply the market.
Holders that also distribute in Brazil: top 20
- 1PASSROD IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS PARA SAÚDE LTDA - MERibeirão Preto, SP855 registrationsDistributor
- 2CIRURGICA FERNANDES - COMERCIO DE MATERIAIS CIRURGICOS E HOSPITALARES - SOCIEDADE LIMITADASantana De Parnaíba, SP654 registrationsDistributor
- 3VYTTRA DIAGNOSTICOS S.A.São Paulo, SP636 registrationsDistributor
- 4633 registrationsDistributor
- 5Enzytec Biotecnologia Ltda.Belo Horizonte, MG470 registrationsDistributor
- 6402 registrationsDistributor
- 7MEDIX BRASIL LTDACascavel, PR373 registrationsDistributor
- 8BIOSYS LTDANiterói, RJ319 registrationsDistributor
- 9QUIBASA - QUIMICA BASICA LTDABelo Horizonte, MG312 registrationsDistributor
- 10WERFEN MEDICAL LTDABarueri, SP300 registrationsDistributor
- 11300 registrationsDistributor
- 12299 registrationsDistributor
- 13293 registrationsDistributor
- 14LABTEST DIAGNOSTICA S/ALagoa Santa, MG281 registrationsDistributor
- 15CEDRS - GESTAO EMPRESARIAL LTDASão Bernardo Do Campo, SP280 registrationsDistributor
- 16LABORLAB PRODUTOS PARA LABORATÓRIOS LTDA EPPGuarulhos, SP266 registrationsDistributor
- 17NUTRIEX IMPORTACAO E EXPORTACAO DE PRODUTOS NUTRICIONAIS E FARMOQUIMICOS LTDAAparecida De, Goiânia248 registrationsDistributor
- 18CRAL ARTIGOS PARA LABORATORIO LTDACotia, SP240 registrationsDistributor
- 19Vida Biotecnologia Ltda - MEBelo Horizonte, MG239 registrationsDistributor
- 20E TAMUSSINO E CIA LTDARio De Janeiro, RJ227 registrationsDistributor
See every independent distributor in Brazil on the country page.
Independent holders in Brazil: 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.
- 12,387 registrationsRegulatory representative
- 2697 registrationsRegulatory representative
- 3586 registrationsRegulatory representative
- 4MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDAVargem Grande Paulista, SP423 registrationsRegulatory representative
- 5Domo Salute Consultoria Regulatória LtdaPorto Alegre, RS242 registrationsRegulatory representative
- 6LATIN HEALTH IMPORTADORA E DISTRIBUIDORA LTDA.Vargem Grande Paulista, SP165 registrationsRegulatory representative
- 7130 registrationsRegulatory representative
- 8WISSEN CONSULTORIA LTDAPirassununga, SP46 registrationsRegulatory representative
- 9MIVIDA ASSUNTOS REGULATORIOS LTDARio De Janeiro, RJ27 registrationsRegulatory representative
- 10BRAZIL REGULATORY LTDAVinhedo, SP15 registrationsRegulatory representative
- 1115 registrationsRegulatory representative
- 12REACH LATAM CONSULTORIA E COMÉRCIO EXTERIOR LTDAEmbu Das Artes, SP13 registrationsRegulatory representative
- 13CONNECT ASSUNTOS REGULATÓRIOS, COMÉRCIO E DISTRIBUIDORA DE PRODUTOS MÉDICO-HOSPITALRES LTDAAsa Norte, DF12 registrationsRegulatory representative
- 14ANCORUP CONSULTORIA LTDAVila Velha, ES12 registrationsRegulatory representative
- 15FRDB CONSULTORIA REGULATORIA LTDA.Embu Das Artes, SP8 registrationsRegulatory representative
- 16lotus industria e comercio ltdaPato Branco, PR8 registrationsRegulatory representative
- 17PLANITRADE ASSESSORIA COMÉRCIO E REPRESENTAÇÕES LTDAPorto Alegre, RS7 registrationsRegulatory representative
- 18DOIS RIOS CONSULTORIA, PLANEJAMENTO E GESTAO LTDA.Rio De Janeiro, RJ4 registrationsRegulatory representative
- 19MANAGER CONSULTORIA EM INFORMATICA LTDAFlorianópolis, SC3 registrationsRegulatory representative
- 202 registrationsRegulatory representative
Medical device registration in Brazil with CE or FDA clearance
With CE marking: No reliance route on CE marking is confirmed in the source.
With FDA clearance: FDA clearance shortens part of the local 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.
Brazil risk classes I and II (devices and IVDs) are notified, not registered; the Good Manufacturing Practices certificate is tied to classes III and IV. A Brazil Registration Holder is still needed. Brazil classes I and II map roughly to EU classes I and IIa (IVDR A and B).
Sources: ANVISA Instrucao Normativa 290/2024, optimised device registration based on an equivalent foreign regulatory authority (AREE), ANVISA RDC 751/2022 (English), Articles 6 and 7, ANVISA RDC 830/2023 on IVDs (English), Articles 6 and 7. 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
ANVISA product registration search (Consulta a registro de produtos). Search by product or by company. Each record names the company that holds it.
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, 33 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
Registration holders in Brazil: questions
Who can be a registration holder in Brazil?
ANVISA issues a device registration or notification to a holder: a legal entity, either the manufacturer or an importer, that is responsible for the device in Brazil.
Can a distributor hold my registration in Brazil?
In the Index, 1,329 of the 4,204 ANVISA registration holders listed for Brazil are also independent distributors. Whether your distributor should hold it is a separate decision, because the holder controls market access: see Who holds the registration.
Is there a list of ANVISA registration holders?
Yes. This page lists the top 50 of the 4,204 ANVISA registration holders the Index holds for Brazil, each linked to its profile, and the CSV carries 4,202 company rows. The official record is the ANVISA product registration search (Consulta a registro de produtos).
How do I check who holds a device registration in Brazil?
Use the ANVISA product registration search (Consulta a registro de produtos). Search by product or by company. Each record names the company that holds it.
Sources
- Brazil ANVISA medical device registrations, open data portal: 4,204 establishments, last seen 23 October 2026. Brazilian government open data.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 61 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 15 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 6 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 17 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.
Registry data. Bastion Hale does not vouch for any establishment.