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.

ANVISA has launched a public call for contributions to support the revision of Brazil's medical device vigilance regulatory framework, seeking feedback from medical device registration holders on post-market surveillance requirements and future regulatory developments.

ANVISA’s new 2024–2025 GCP inspection report highlights critical findings in clinical trials, data integrity, electronic systems, SOPs, and investigational product management. Learn what manufacturers and sponsors should review.

ANVISA publishes draft rules on UDI data transmission and SIUD management in Brazil. Learn how the new requirements impact medical device manufacturers.

ANVISA publishes final version (v1.3) of its Medical Device Registration Manual. See what manufacturers need to know for regulatory submissions in Brazil.

The newly published ANVISA manual provides updated guidance for the regularisation of medical devices and in vitro diagnostic products in Brazil. Covering topics such as device classification, documentation, GMP certification, and use of the Solicita system, this manual is essential for medical device and IVD manufacturers looking to expand into Brazil. By ensuring regulatory compliance, manufacturers can achieve faster access to Brazil’s large and growing healthcare market.

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.