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                                                  Estabelece Regulamento Técnico de Produtos para Diagnóstico de uso in
                                                  vitro e seu Registro, Cadastramento, e suas alterações, revalidações e
                                                  cancelamento.

A Diretoria Colegiada da Agência Nacional de Vigilância Sanitária, no uso da atribuição que lhe confere o inciso IV do art.
11 do Regulamento aprovado pelo Decreto nº 3.029, de 16 de abril de 1999, e tendo em vista o disposto no inciso II e nos §§
1º e 3º do art. 54 do Regimento Interno aprovado nos termos do Anexo I da Portaria nº 354 da ANVISA, de 11 de agosto de
2006, republicada no DOU de 21 de agosto de 2006, em reunião realizada em 6 de novembro de 2006, e
considerando as disposições constitucionais e a Lei Federal n°8080, de 19 de setembro de 1990 que tratam das condições
para a promoção, proteção e recuperação da saúde, como direito fundamental do ser humano;
considerando a necessidade de atualizar os procedimentos para registro, cadastramento, alteração, revalidação e
cancelamento de Produtos para Diagnóstico de uso in vitro de que tratam a Lei n°6360, de 23 de setembro de 1976, o
Decreto n° 79.094, de 5 de janeiro de 1977;
adota a seguinte Resolução de Diretoria Colegiada e eu, Diretor-Presidente Substituto, determino a sua publicação:

              


                  



       







                



               




              

              






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
    CLÁUDIO MAIEROVITCH PESSANHA HENRIQUES
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    
    
    
    
    
                   
         
    
    
    
                
    
    
    
    
    
                  
            
                 
    
         
    
    
                 
                
    
    
                     
    
                    
                
    
    
                  
    
                     
    
    
    
    
    




2

              


              




              
              


            



                





             

            

            


             

           

 
            

               

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


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




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    
    
                    
    
    
                    
    
    
    
    
    
                     
    
    
    
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    
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    
    
    
    
    
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    
                 
    
    
                    
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    
    
                  
    
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4
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
             
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



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              



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

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
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
                

             



              


              
            
             


             
             




    




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
    
    
                  
    
    
                    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
                   
    
                    
    
                  
    
    
    
    
    
    
                  
    
    
    
    
    
    
    
                
    
                       
    
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


                

             

             
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
              


              
            
             


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

              




              


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
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


              

               
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
               








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                       
    
    
    
    
    
    
                     
    
    
    
    
    
    
    
                      
    
    
    
    
                 
    
    
    
    
    
                    
    
                    
    
                  
    
    
    
    
              
    
    
    
    
    
    
                
    




8
               



             


             
               


                




              



                 


                    




              




                 








                






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RDC Nº 206, DE 17 DE NOVEMBRO DE 2006
RDC Nº 206, DE 17 DE NOVEMBRO DE 2006
RDC Nº 206, DE 17 DE NOVEMBRO DE 2006

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RDC Nº 206, DE 17 DE NOVEMBRO DE 2006

  • 1.  Estabelece Regulamento Técnico de Produtos para Diagnóstico de uso in vitro e seu Registro, Cadastramento, e suas alterações, revalidações e cancelamento.  A Diretoria Colegiada da Agência Nacional de Vigilância Sanitária, no uso da atribuição que lhe confere o inciso IV do art. 11 do Regulamento aprovado pelo Decreto nº 3.029, de 16 de abril de 1999, e tendo em vista o disposto no inciso II e nos §§ 1º e 3º do art. 54 do Regimento Interno aprovado nos termos do Anexo I da Portaria nº 354 da ANVISA, de 11 de agosto de 2006, republicada no DOU de 21 de agosto de 2006, em reunião realizada em 6 de novembro de 2006, e considerando as disposições constitucionais e a Lei Federal n°8080, de 19 de setembro de 1990 que tratam das condições para a promoção, proteção e recuperação da saúde, como direito fundamental do ser humano; considerando a necessidade de atualizar os procedimentos para registro, cadastramento, alteração, revalidação e cancelamento de Produtos para Diagnóstico de uso in vitro de que tratam a Lei n°6360, de 23 de setembro de 1976, o Decreto n° 79.094, de 5 de janeiro de 1977; adota a seguinte Resolução de Diretoria Colegiada e eu, Diretor-Presidente Substituto, determino a sua publicação:                                                                                                                                 1
  • 2.  CLÁUDIO MAIEROVITCH PESSANHA HENRIQUES                                                                                                                                                                                                                          2
  • 3.                                                                                                                                                                                                                           3
  • 4.                                                                                                                                          4
  • 5.                                                                                                                                                                                         5
  • 6.                                                                                                                                                                      6
  • 7.                                                                                                                                                                                                                     7
  • 8.                                                                                                                                                                                     8
  • 9.                                                                                                                                                                                                                        9