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 has launched Call Notice 5/2026 to select up to 10 innovative medical device projects for regulatory evaluation and continuous dialogue in Brazil.

Anvisa has published technical documentation supporting the integration of electronic prescription systems with the SNCR, including API specifications, technical requirements and developer guidance.

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.

With the publication of the preliminary SIUD manual, Anvisa has begun the official implementation of the Unique Identification of Medical Devices (UDI) system in Brazil. This system, provided for in RDC 591/2021, obliges manufacturers and legal representatives to register the UDI-DI code in the system, ensuring greater traceability and transparency in the Brazilian market. Separate submissions are required per model, with mandatory fields such as GMDN codes and technical data for the device.

Anvisa has opened Public Consultation No. 1,313/2025 to receive suggestions on the Normative Instruction that regulates the transmission and management of the UDI Brasil database, as provided for in RDC No. 591/2021. The regulation will detail the technical and operational criteria for data transmission, making it essential for companies in the sector to be prepared for the future obligation.