ANVISA Medical Device Registration and Approval

Realização de pré-auditoria de qualidade para verificação do atendimento aos requisitos das normas regulatórias (auditoria em empresas nacionais e estrangeiras para verificação da adequação à RDC 16 da ANVISA)
4 de novembro de 2018
Why choose QR Consulting as your Registration Holder?
5 de novembro de 2018

ANVISA Medical Device Registration and Approval

Registration Routes in Brazil: The first step in the Brazilian regulatory process is to determine the correct classification of your medical device. Lower risk (Class I and II devices) will follow the Cadastro registration route, which includes a simplified application. Higher risk (Class III and IV devices) must follow the normal registration process.

If your device is Class I or II, you must submit an application and legal documents to ANVISA for review and approval. Class I and II device manufacturers must also compile a comprehensive technical dossier for their BRH to keep on file, along with proposed labeling and IFU, in case of an ANVISA audit.

Class III and IV device manufacturers must prepare a Technical File that includes clinical data, clinical studies, and additional device information. Legal documents, IFUs, and proposed labeling are also included in the Technical File. Class III and IV registrations expire after ten years; Class I and II registrations do not expire.

INMETRO or ANATEL certification requirements: ANVISA requires certain medical devices to be certified by The National Institute of Metrology, Standardization and Industrial Quality (INMETRO) and/or ANATEL (the regulatory agency for telecommunication) which is responsible for the establishment of technical standards in Brazil. INMETRO certification is often required for electro-medical devices subject to IEC 60601, as well as some other medical devices. QR Consulting can assist by selecting an INMETRO and/or ANATEL certifier and communicate with them on your behalf.

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