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 I - NOTIFICAÇAO
- 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.