Regulatory Open Forum

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  • 1.  RDC 665/2022 English version

    Posted 20-Apr-2022 10:44

    Good Morning All, 

    Just wondering if anyone has an English copy of RDC 665/2022 or any idea as to where to find it? So far I am only finding copies in Portuguese. We are in the process of terminating our current Registration Holder so they are not an option. 

    Thanks in advance. 



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    Rebecca Tucek
    Melbourne FL
    United States
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  • 2.  RE: RDC 665/2022 English version

    Posted 20-Apr-2022 11:50
    ANVISA RDC 665/2022 is the updated GMP regulation for medical devices and IVD.  You may need to file an administrative change request to update the registration holder information for your device?  This seems silly but Google translate does a decent job sometimes. See below :) 

    PT: Art. 1º Esta Resolução dispõe sobre as Boas Práticas de Fabricação (BPF) de Produtos Médicos e Produtos para Diagnóstico de Uso In Vitro, estabelecendo os requisitos que descrevem as BPF para métodos e controles usados no projeto, compras, fabricação, embalagem, rotulagem, armazenamento, distribuição, instalação e assistência técnica aplicáveis à fabricação de produtos médicos e produtos para diagnóstico de uso in vitro.

    EN: Art. 1 This Resolution provides for Good Manufacturing Practices (GMP) of Medical Products and Diagnostic Products for In Vitro Use, establishing the requirements that describe the GMP for methods and controls used in the design, purchasing, manufacturing, packaging, labeling, storage, distribution, installation and technical assistance applicable to the manufacture of medical products and products for in vitro use diagnosis.

    Thank you / Obrigada,

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    Juliane Carvalho RAC, MSc
    Lead Regulatory Health Project Manager
    United States
    **My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
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  • 3.  RE: RDC 665/2022 English version

    Posted 21-Apr-2022 07:10
    Hello.

    There is an English link to 655/2022 at the bottom of this page.
    https://passarini.com.br/en/anvisa-rdc-no665-gmp-for-medical-products-and-in-vitro-diagnostic-products/


    Regards,
    Dawn

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    Dawn Snow
    Marshfield MA
    United States
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