Anvisa Publishes Manual on Notification of Risk Class I and II Medical Devices
Anvisa has published a manual on the notification process for risk class I and II medical devices in Brazil, covering company regularization, product classification, Solicita electronic submission, documentation requirements and secondary petitions.
Anvisa Introduces Electronic Registration for International Manufacturers of Risk Class I and II Medical Devices
Anvisa has announced that registration requests for international manufacturers of risk class I and II medical devices, including IVDs, must now be submitted electronically through the Solicita system using subject code 80326.
Anvisa to Discontinue Sicert Medical Device Certificate Issuance System
Anvisa has announced the permanent discontinuation of the Sicert Medical Device Certificate Issuance System, completing the transition to the new certificate generation tool integrated into the Solicita System.