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.

22. January 2018

Anvisa expands the validity of registrations for Brazil from previously 5 years to now 10 years!

03. November 2017

The Brazilian system for registration of medical devices requires a mandatory product inspection under the so called "Sistema Brasileiro de Avaliação da Conformidade" (SBAC). This product inspection is one of the prerequisites for a "Cadastro or Registro" (listing or registration procedure) with the Brazil ANVISA. The most current list of the document "INSTRUÇÃO NORMATIVA No 4", 2015 is published in the DOU No. 211. Please take into account for any of the planned market introduction for...

29. September 2017

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