Anvisa now requires digital signatures in medical device processes and petitions
The National Health Surveillance Agency – ANVISA circulated this week through Solicita System the Circular Letter No. 1/2022/SEI/GGTPS/DIRE3/ANVISA, which mainly provides with guidelines for signatures in process and petition documents for medical devices.
In this letter, Anvisa informs that the processes, petitions and documents filed must be digitally signed by the legally authorized person (or persons) of the company. To this end, e-CNPJ or e-CPF type certificates must be used, issued by certifying authorities recognized by the Brazilian Public Key Infrastructure – ICP/Brasil, as provided in the Collegiate Board Resolutio – RDC n° 470/2021.
Scanned documents must exclusively use a qualified signature (with a digital certificate in the ICP-Brasil standard), as provided for in Decree No. 10.278/2020. Native-digital documents, on the other hand. Can make use of both qualified (ICP-Brasil) and advanced signatures (used on the Gov.BR portal, at no cost to the citizen), according to Law No. 14.063/2020.
Therefore, as provided for in art. 10 of RDC 470/2021, signature formats that are not provided for in the legislation for processes, petitions and documents filed will no longer be accepted.
For more information and explanations about it, send us an e-mail: contato@passarini.com.br.
Passarini Group
Published: 02/09/2022
