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.