30. April 2019

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.

29. September 2017

By publishing RDC 179/2017 ANVISA introduces 3 options of showing compliance to the Brazilian GMP requirements.