1. Marc

    Free Medical Device Registration in Brazil - ANVISA 2019-04-24

    Some people asked Marcelo - maybe years ago :) - to write something about the medical device registration process regulated by Anvisa in Brazil. Included is a flowchart (based on a guidance document Anvisa developed) for a potential client and thought it might help others here. It´s a generic...
  2. A

    How should the Medical Device OEMs be declared to ANVISA?

    Hello! can any of you help me understand how should the OEMs be declared to ANVISA? a GMP audit is required for the Chinese manufacturer of the main parts? Thanks!
  3. Marcelo Antunes

    Medical Device News Disponibilizados textos das CPs 584, 585 e 585 da ANVISA

    Texts of ANVISA CPs 584, 585 and 585 are available. Comments and suggestion until March 9th. Disponibilizados textos das CPs 584, 585 e 585 da ANVISA. Comentários e sugestões até 9 de Março. Consulta Pública n° 584, de 20 de dezembro de 2018 – Proposta de Resolução que Dispõe sobre o...
  4. Marcelo Antunes

    Medical Device News ANVISA – Consulta Pública nº 586 de 20/12/2018 – Diretrizes de Garantia da Qualidade para Validação, Monitoramento e Controle de Rotina dos Processos

    ANVISA – Public Consultation No. 586 of 12/20/2018 – Proposal for Normative Ruling on the Quality Assurance Guidelines for Validation, Monitoring and Routine Control of Sterilization Processes and Automated Processes for Cleaning and Disinfection in Health Services. ANVISA – Consulta Pública nº...
  5. Marcelo Antunes

    Medical Device News ANVISA – Consulta Pública nº 585 de 20/12/2018 – Boas Práticas para o Processamento de Produtos utilizados na assistência à saúde

    ANVISA – Public Consultation No. 585 of 12/20/2018 – Proposal of Resolution of the Collegiate Board of Directors – RDC, which provides for the requirements of Good Practices for the Processing of Products used in health care, and provides other measures. ANVISA – Consulta Pública nº 585 de...
  6. Marcelo Antunes

    Medical Device News ANVISA – Consulta Pública nº 584 de 20/12/2018 – Enquadramento de dispositivo médico como de uso único ou reutilizável

    ANVISA – Public Consultation nº 584 of 12/20/2018 – Framework of medical device as single use or reusable ANVISA – Consulta Pública nº 584 de 20/12/2018 – Enquadramento de dispositivo médico como de uso único ou reutilizável Continue reading...
  7. Marcelo Antunes

    Medical Device News New ANVISA health services public consultations – Consultas públicas de serviços em saúde

    New ANVISA public consultations related to quality and safety of health services. Novas consultas públicas da ANVISA relacionadas à qualidade e segurança de serviços em saúde. Consulta Pública nº 573 de 10/12/2018 – Proposta de Resolução de Diretoria Colegiada que dispõe sobre os requisitos...
  8. Marcelo Antunes

    Medical Device News Novas normas publicadas pelo ABNT/CB-026 / New standards published by ABNT/CB-026

    O ABNT / CB-026 é o comitê técnico brasileiro que lida com a maioria das normas relacionados a dispositivos médicos. Mais informações sobre a ABNT / CB-026 podem ser encontradas no site As normas recentemente publicadas pelo ABNT / CB-026 estão abaixo. ABNT/CB-026 is the...
  9. J

    INMETRO process of Hypodermic Needle in Brazil

    Hello everyone:) I need help from a Forums member regarding the INMETRO certification in Brazil. Our company are preparing for a Brazil medical device registraion of a Class 3 product. Our products are inserted into the human body and do not require INMETRO certification, but Hypodermic...
  10. J

    Brazil GMP license work with multiple BRH?

    Hello, I have a Brazil GMP license related question. Much appreciated for any input. Currently we are a foreign manufacturer holding the B-GMP license and also a few dozen IVD products registered by our BRH/local distributor. I understand that these products are tied to our current BRH and my...
  11. J

    Brazil - Submitting Technical Files

    We are currently setting up an agreement with a company to be our registration holder in Brazil. However, we do not want to release the technical files to them and have been told that we can submit all registration information to the BRH other than the technical files, we would submit the tech...
  12. Marc

    200-year-old museum in Rio de Janeiro Destroyed by Fire - 2 SEPT 2018

    200-year-old National Museum of Brazil in Rio de Janeiro Destroyed by Fire CBS's article: National Museum fire today: Massive blaze engulfs 200-year-old museum in Rio de Janeiro, Brazil - CBS News National Museum in northern Rio, which houses artifacts from Egypt, Greco-Roman art and...
  13. A

    MDSAP benefit for manufacturer of low-risk devices

    Hi there, This is my first post to the Cove (but I come here often to read many interesting threads), I hope it will be of interest for some of you. My question today is about MDSAP. I work for a manufacturer of a low risk medical device (ISO13485 certified), and we are selling in all...
  14. S

    Compliance to Brazil GMP requirements

    Can I get your thoughts on how to proceed for getting compliant to ANVISA Brazil GMP requirements? We have a quality system complaint to ISO 13485:2016 and 21 CFR Part 820 so what needs to be done to show compliance to ANVISA requirements - being a contract manufacturer, do we just show...
  15. C

    Substantial Change in MDSAP Audit

    We recently exited the Brazilian market. We consulted with ANVISA to inform them of our decision. Now at our MDSAP audit, the auditor is claiming we did not notify the MDSAP Conformity Assessment Body (I guess that's what you call it) of the change. Our procedures for determining substantial...
  16. A

    Brazil - New RDC 183 - CBPF (GMP) question

    Hello all, I was informed that ANVISA issued an amendment to the GMP regulation, and I have some doubts about it. Does anyone know if we should expect a notification from ANVISA requesting additional documents, according to the following article? Art. 5º - Fica facultado ao...
  17. A

    Brazil - Import Medical Device Spare Parts - Without license

    Hello all!, I was hoping you can help me with a situation. We have a valid license for a device in Brazil. This license will end soon and we are not planning on further market this specific device in Brazil (but a succeeding model). BUT we already sold some of the devices in Brazil and we...
  18. A

    Medical Device License Transfer in Brazil

    Hello all, I hope you can help me with a doubt regarding License transfers in Brazil, particularly for REGISTRO. Given the following situation: 1. Let’s say that a Brazilian importer (Company A) has registered a product with ANVISA, manufactured by a foreign manufacturer (Company X). 2. The...
  19. A

    Brazil IVD Registration Fees

    Hello, Please does anyone know the current fee for registration of a class II IVD in Brazil? Thanks
  20. 3

    Brasil: OEM Medical Device Business - Product Design Customization

    Hi, I've skimmed through the massive amount of forums / posts regarding medical device registration in Brasil but haven't found an answer to my following questions: Our company is doing OEM business in the medical device sector. Hence, we're interested in customizing e.g. the design / trade...
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