Brazil ANVISA introduced a simplified NOTIFICATION process

A third procedure simplifying the registration process in Brazil was introduced with the publication of the RDC 270/2019.

All Class I products now just need a "NOTIFICATION" with ANVISA.


The procedures for market access in Brazil are now:


  • Class II - CADASTRO
  • Class III and IV - REGISTRO

Update 2019-11-13:

After introducing the new procedure ANVISA also published new application documents as combined form for NOTIFICAÇAO and CADASTRO.