24 de fevereiro de 2019

BRAZIL NEWS: New Electronic Petition System for Medical Devices available on next Tuesday

From: www.anvisa.gov.br

Another evolution in Anvisa's Electronic Petitioning System, will allow the companies to submit all their documents do the General Management of Medical Devices Technology (GGTPS) [Gerência Geral de Tecnologia de Produtos para Saúde] in electronic format.
It will be available on next Tuesday (February, 26)
The new system does not require the forwarding of physical documents to GGTPS by companies. In this way, the procedures will be streamlined, with a significant reduction of administrative and logistical costs, both for companies and for the Agency itself.

Anvisa inaugurated, on January 21 of this year, in the Electronic Petitioning System, the Electronic Compliance of Requirement for GGTPS. This made it possible for companies to electronically submit the necessary documents to meet the notifications of requirements received as a result of the analysis of the petitions.

Online Procedures
To send the documents, the user must log in to the Electronic Request System and click on the option "Electronic compliance of requirement" [Cumprimento eletrônico de exigência]. Once this has been done, the license notification number will be informed, so that the user is directed to the file upload screen. Once the necessary steps have been taken, compliance with the requirement will be automatically filed and made available for GGTPS analysis.
Important: There is also a guidance available [only portuguese] with all important information about this procedures. Access the document here.

As of 26/2, subject-matter codes for secondary petitions, such as changes, revalidations, additions, cancellations and rectifications, among others, will also be available for electronic petition and protocol.
Before the implementation of the system, that is, before 26/2, it will not be possible to make online protocols.