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PROCESSO DE REGISTRO DE PRODUTOS PARA SAÚDE NO BRASIL

Authors: REIS, Pedro Rodrigo de Sous;

PROCESSO DE REGISTRO DE PRODUTOS PARA SAÚDE NO BRASIL

Abstract

Os produtos para saúde atualmente são enquadrados pela Agência Nacional de Vigilância Sanitário - ANVISA de acordo com o risco intrínseco que podem representar à saúde do usuário, desta forma, o processo de registro se torna parte essencial para os fabricantes cumprirem com os requisitos de segurança e integralidade do produto devendo apresentar através de peticionamento eletrônico uma série de documentos que comprovem a regularidade da empresa tais como: Autorização de Funcionamento da Empresa (AFE), Licença de Funcionamento e Certificado de Boas Práticas de Fabricação (BPF), somando-se ainda as exigências necessárias em relação ao produto de acordo com sua classificação de risco e agrupamento. Assim, este artigo tem como objetivo discorrer sobre o processo de registro de produtos para saúde elucidando sobre o correto processo de peticionamento eletrônico e cumprimento de exigências solicitadas pela ANVISA.

Keywords

Produtos para Saúde, Registro e ANVISA

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
views
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