News
February 5, 2019

ANVISA implements Cumprimento Eletrônico de Exigência electronic system

ANVISA has recently implemented Cumprimento Eletrônico de Exigência system in the currently available Sistema de Peticionamento Eletrônico. Cumprimento Eletrônico de Exigência is intended for regulatory inquiry management during the review process of Medical Device submissions.

Once launched, Medical Device companies will be able to receive and respond to Authority Compliance requests through the platform. The electronic protocol will be available for all Gerência Geral de Tecnologia de Produtos para Saúde (GGTPS) applications.

ANVISA expects to have Cumprimento Eletrônico de Exigência electronic system fully operational in the first half of this year, and has already announced that once the system is launched, physical documents will no longer be accepted.