Last June 28, ANVISA issued a Technical Note about the Cadastro process for lower risk medical and IVD devices (class I and II).

Starting from June 27, 2016 the “Nota Técnica Conjunta no. 02/2016“ simplifies the procedure to submit multiple changes to the same registration using a single application form.

Furthermore, the amendment fee for the application is no longer required.

It is important to specify that the technical note does not mention the higher-risk Medical Devices registrations.

For further information:
http://portal.anvisa.gov.br/documents/33912/447671/NOTA+T%C3%89CNICA+CONJUNTA+GGTPS+e+GEGAR+N%C2%BA+02+de+2016/554d46b0-86a0-498e-979f-cc435687c3db